{"id":12789,"date":"2026-02-19T18:18:00","date_gmt":"2026-02-19T18:18:00","guid":{"rendered":"https:\/\/csiag.eu\/?p=12789"},"modified":"2026-02-21T06:07:24","modified_gmt":"2026-02-21T06:07:24","slug":"imunsunu-terapija","status":"publish","type":"post","link":"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/","title":{"rendered":"Im\u016bn\u0161\u016bnu terapija"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_83 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Satura r\u0101d\u012bt\u0101js<\/p>\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><ul class='ez-toc-list-level-2' ><li class='ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Das_Immunsystem_%E2%80%93_was_macht_das\" >Im\u016bnsist\u0113ma - ko t\u0101 dara?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Was_Immunzelltherapie_macht\" >Ko dara im\u016bn\u0161\u016bnu terapija<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Das_Geniale_daran\" >T\u0101s \u0123enialit\u0101te<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Die_drei_Typen_%E2%80%93_ganz_einfach\" >Tr\u012bs veidi - \u013coti vienk\u0101r\u0161i<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#T-Zellen_und_ihre_Rolle\" >T \u0161\u016bnas un to loma<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Tumorimmunologie-Grundprinzip\" >Audz\u0113ju imunolo\u0123ijas pamatprincips<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#CAR-T-Zelltherapie_%E2%80%93_Konstruktion_und_Mechanismus\" >CAR-T \u0161\u016bnu terapija - dizains un meh\u0101nisms<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Molekularer_Aufbau_des_CAR\" >CAR molekul\u0101r\u0101 strukt\u016bra<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Herstellungsprozess_Autolog\" >Ra\u017eo\u0161anas process (autologs)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Wirkmechanismus_Effektorphase\" >Iedarb\u012bbas meh\u0101nisms un efektora f\u0101ze<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#TCR-T-Zelltherapie_Die_entscheidenden_Unterschiede\" >TCR-T \u0161\u016bnu terapija: galven\u0101s at\u0161\u0137ir\u012bbas<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Warum_TCR_und_nicht_CAR_fur_intrazellulare_Antigene\" >K\u0101p\u0113c TCR, nevis CAR attiec\u012bb\u0101 uz intracelul\u0101rajiem antig\u0113niem?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Struktur_des_therapeutischen_TCR\" >Terapeitisk\u0101 TCR strukt\u016bra<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#TIL-Therapie_%E2%80%93_Prinzip_der_naturlichen_Tumorerkennung\" >TIL terapija - dabisk\u0101 audz\u0113ja atkl\u0101\u0161anas princips<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Biologische_Grundlage\" >Biolo\u0123iskais pamats<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Herstellungsprozess_Lifileucel\" >Ra\u017eo\u0161anas process (Lifileucel)<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Herausforderungen_%E2%80%93_aktuelle_Forschungsansatze\" >Izaicin\u0101jumi - pa\u0161reiz\u0113j\u0101s p\u0113tniec\u012bbas pieejas<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Antigen-Escape\" >Antig\u0113na izk\u013c\u016b\u0161ana<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-19\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#T-Zell-Erschopfung_Exhaustion\" >T-\u0161\u016bnu izs\u012bkums (izs\u012bkums)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-20\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Tumormikroumgebung_TME\" >Audz\u0113ja mikrovide (TME)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-21\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Zytokinsturm_CRS_ICANS\" >Citok\u012bnu v\u0113tra (CRS) un ICANS<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-22\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Allogene_%E2%80%9EOff-the-shelf%E2%80%9C-Therapien\" >Allog\u0113nisk\u0101s \u201egatav\u0101s\u201c terapijas<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-23\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#27_Quantitative_Wirksamkeitsdaten_im_Uberblick\" >2.7 Kvantitat\u012bvie efektivit\u0101tes dati \u012bsum\u0101<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-24\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Weiterfuhrende_Literatur_Ressourcen\" >Papildu las\u0101mviela un resursi<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-25\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Weltweit_zugelassene_Immunzelltherapien\" >Pasaul\u0113 apstiprin\u0101tas im\u016bn\u0161\u016bnu terapijas<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-26\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Einleitung_Die_drei_grosen_Klassen\" >Ievads: Tr\u012bs galven\u0101s klases<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-27\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#CAR-T-ZELLTHERAPIEN\" >CAR-T \u0160\u016aNU TERAPIJA<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-28\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Tisagenlecleucel_Kymriah%C2%AE_%E2%80%93_Novartis\" >Tisag\u0113nleikleucels (Kymriah\u00ae) - Novartis<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-29\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Axicabtagene_Ciloleucel_Yescarta%C2%AE_%E2%80%93_KiteGilead\" >Aksikabtag\u0113na ciloleucels (Yescarta\u00ae) - Kite\/Gilead<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-30\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Brexucabtagene_Autoleucel_Tecartus%C2%AE_%E2%80%93_KiteGilead\" >Brexucabtagene Autoleucel (Tecartus\u00ae) - Kite\/Gilead<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-31\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Lisocabtagene_Maraleucel_Breyanzi%C2%AE_%E2%80%93_Bristol_Myers_Squibb\" >Lisocabtag\u0113ns Maraleucel (Breyanzi\u00ae) - Bristol Myers Squibb<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-32\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Idecabtagene_Vicleucel_Abecma%C2%AE_%E2%80%93_Bristol_Myers_Squibb_2seventy_bio\" >Idecabtagene Vicleucel (Abecma\u00ae) - Bristol Myers Squibb \/ 2seventy bio<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-33\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Ciltacabtagene_Autoleucel_Carvykti%C2%AE_%E2%80%93_JanssenLegend_Biotech\" >Ciltacabtagene Autoleucel (Carvykti\u00ae) - Janssen\/Legend Biotech<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-34\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Obecabtagene_Autoleucel_Aucatzyl%C2%AE_%E2%80%93_Autolus_neu_112024\" >Obecabtagene Autoleucel (Aucatzyl\u00ae) - Autolus (jauna: 11.2024)<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-35\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#WELTWEIT_ZUGELASSEN_%E2%80%93_NICHT_IN_USAEU_weitere_Lander\" >PASAUL\u0112 PIE\u013bAUTS - NE ASV\/ES (cit\u0101s valst\u012bs)<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-36\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#China_NMPA_%E2%80%93_vier_zusatzliche_CAR-T-Produkte\" >\u0136\u012bna (NMPA) - \u010detri papildu CAR-T produkti<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-37\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Indien_CDSCO\" >Indija (CDSCO)<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-38\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#TCR-T-ZELLTHERAPIEN_zugelassen\" >TCR-T \u0161\u016bnu terapijas (at\u013cautas)<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-39\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Afamitresgene_Autoleucel_Tecelra%C2%AE_%E2%80%93_Adaptimmune_August_2024\" >Afamitresgene Autoleucel (Tecelra\u00ae) - Adaptimmune (2024. gada augusts)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-40\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Tebentafusp-tebn_Kimmtrak%C2%AE_%E2%80%93_Immunocore_Januar_2022\" >Tebentafusp-tebn (Kimmtrak\u00ae) - Immunocore (2022. gada janv\u0101ris)<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-41\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#TIL-THERAPIE_zugelassen\" >TIL-TERAPIJA (at\u013cauta)<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-42\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Lifileucel_Amtagvi%C2%AE_%E2%80%93_Iovance_Biotherapeutics_Februar_2024\" >Lifileucel (Amtagvi\u00ae) - Iovance Biotherapeutics (2024. gada febru\u0101ris)<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-43\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Ubersicht_aller_Immunzelltherapien_weltweit\" >P\u0101rskats par vis\u0101m im\u016bn\u0161\u016bnu terapij\u0101m vis\u0101 pasaul\u0113<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-44\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Nebenwirkungen_%E2%80%93_Was_alle_Therapien_verbindet\" >Blakuspar\u0101d\u012bbas - kas kop\u012bgs vis\u0101m terapij\u0101m<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-45\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Wo_werden_diese_Therapien_in_Deutschland_angeboten\" >Kur V\u0101cij\u0101 tiek pied\u0101v\u0101tas \u0161\u012bs terapijas?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-46\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Ausblick_Was_kommt_als_nachstes\" >Perspekt\u012bvas: Kas t\u0101l\u0101k?<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-1'><a class=\"ez-toc-link ez-toc-heading-47\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#GKV-Erstattung_von_Immunzelltherapien_in_Deutschland\" >Im\u016bn\u0161\u016bnu terapijas SHI kompens\u0101cija V\u0101cij\u0101<\/a><ul class='ez-toc-list-level-2' ><li class='ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-48\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#CAR-T-Zelltherapien\" >CAR-T \u0161\u016bnu terapijas<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-49\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#AMNOG_NUB-Verfahren\" >AMNOG un NUB proced\u016bra<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-50\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Fruhe_Nutzenbewertung_durch_den_G-BA\" >G-BA veikts agr\u012bns ieguvumu nov\u0113rt\u0113jums<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-51\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Preisverhandlung_nach_%C2%A7_130b_SGB_V\" >Sarunas par cenu saska\u0146\u0101 ar SGB 130.b pantu V<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-52\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#NUB-Verfahren_fur_Krankenhauser\" >NUB proced\u016bra slimn\u012bc\u0101m<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-53\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Die_Realitat_Einzelfallantrage_und_Burokratie\" >Realit\u0101te: individu\u0101li pieteikumi un birokr\u0101tija<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-54\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Das_%E2%80%9EPay-for-Outcome%E2%80%9C-Modell\" >\u201eMaks\u0101juma par rezult\u0101tu\u201c modelis<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-55\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Welche_CAR-T-Produkte_sind_in_Deutschland_erstattungsfahig\" >Kuri CAR-T produkti ir kompens\u0113jami V\u0101cij\u0101?<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-56\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Kimmtrak_Tebentafusp_%E2%80%93_Sonderfall\" >Kimmtrak (Tebentafusp) - \u012bpa\u0161s gad\u012bjums<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-57\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#TIL-Therapie_Lifileucel_Amtagvi_%E2%80%93_In_Deutschland_derzeit_NICHT_erstattungsfahig\" >TIL terapija (Lifileucel \/ Amtagvi) - pa\u0161laik V\u0101cij\u0101 NAV kompens\u0113jama.<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-58\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#TCR-T-Therapien_Afami-cel_Tecelra_%E2%80%93_In_Europa_nicht_zugelassen\" >TCR-T terapija (Afami-cel \/ Tecelra) - Eirop\u0101 nav at\u013cauta.<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-59\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Was_tun_wenn_die_Kasse_ablehnt_Rechtliche_Moglichkeiten\" >Ko dar\u012bt, ja apdro\u0161in\u0101\u0161anas sabiedr\u012bba atsaka? Juridisk\u0101s iesp\u0113jas<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-60\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Osterreich\" >Austrija<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-61\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Schweiz\" >\u0160veice<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-62\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Zusammenfassung\" >Kopsavilkums<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-63\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#PKV_und_Immunzelltherapie_%E2%80%93_Die_vollstandige_Rechtslage\" >PKV un im\u016bn\u0161\u016bnu terapija - piln\u012bga juridisk\u0101 situ\u0101cija<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-64\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Das_rechtliche_Fundament_%C2%A7_192_VVG_und_MBKK_2009\" >Juridiskais pamats: VVG 192. pants un MB\/KK 2009. gads<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-65\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Der_Schlusselbegriff_%E2%80%9EMedizinisch_notwendige_Heilbehandlung%E2%80%9C\" >Galvenais termins: \u201emedic\u012bniski nepiecie\u0161ama \u0101rst\u0113\u0161ana\u201c.\u201c<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-66\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Das_Richtungsurteil_OLG_Frankfurt_29062022_%E2%80%93_Az_7_U_14021\" >Galvenais spriedums: OLG Frankfurt, 29.06.2022. - Ref. 7 U 140\/21.<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-67\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Das_%E2%80%9Eauffallige_Missverhaltnis%E2%80%9C_nach_%C2%A7_192_Abs_2_VVG_%E2%80%93_und_warum_es_bei_CAR-T_nicht_greift\" >\u201eAc\u012bmredzama disproporcija\u201c saska\u0146\u0101 ar VVG 192. panta 2. punktu - un k\u0101p\u0113c t\u0101 neattiecas uz CAR-T<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-68\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Das_Voranfrageverfahren_nach_%C2%A7_192_Abs_8_VVG_%E2%80%93_der_wichtigste_praktische_Schritt\" >Iepriek\u0161\u0113jas izmekl\u0113\u0161anas proced\u016bra saska\u0146\u0101 ar VVG 192. panta 8. punktu - vissvar\u012bg\u0101kais praktiskais solis<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-69\" href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/#Bei_Ablehnung_Rechtsmittel_und_Klage\" >Atteikuma gad\u012bjum\u0101: p\u0101rs\u016bdz\u012bba un tiesved\u012bba.<\/a><\/li><\/ul><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<span class=\"span-reading-time rt-reading-time\" style=\"display: block;\"><span class=\"rt-label rt-prefix\">Las\u012b\u0161anas laiks<\/span> <span class=\"rt-time\"> 20<\/span> <span class=\"rt-label rt-postfix\">protokols<\/span><\/span>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Das_Immunsystem_%E2%80%93_was_macht_das\"><\/span>Im\u016bnsist\u0113ma - ko t\u0101 dara?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Im\u016bnsist\u0113ma uztur veselu armiju izl\u016bku, kaujinieku (<em>T-\u0161\u016bnas<\/em>) un pal\u012bgiem. T\u0101s nep\u0101rtraukti patrul\u0113 organism\u0101 un mekl\u0113 iebruc\u0113jus, piem\u0113ram, bakt\u0113rijas, v\u012brusus, k\u0101 ar\u012b pa\u0161a organisma \u0161\u016bnas, kas k\u013cuvu\u0161as me\u017eon\u012bgas - v\u0113\u017ea \u0161\u016bnas.<\/p>\n\n\n\n<p>Parasti im\u016bnsist\u0113mas sarg\u0101t\u0101ji \u0101tri atkl\u0101j \u0161\u0101das niknumainas \u0161\u016bnas, nogalina t\u0101s un atliekas aizv\u0101c un iz\u0101rda. Tas notiek nep\u0101rtraukti katru dienu. \u0160\u0101d\u0101 veid\u0101 im\u016bnsist\u0113ma ne\u013cauj vairumam v\u0113\u017ea \u0161\u016bnu izplat\u012bties un t\u0101s savlaic\u012bgi k\u013c\u016bst nekait\u012bgas.<\/p>\n\n\n\n<p>Ta\u010du v\u0113\u017ea \u0161\u016bnas ir izdomas bag\u0101tas, jo t\u0101s par katru cenu v\u0113las izdz\u012bvot. T\u0101p\u0113c t\u0101s mask\u0113jas, efekt\u012bvi sl\u0113pjas no im\u016bnsist\u0113mas sargiem un turpina izplat\u012bties gandr\u012bz nekontrol\u0113ti. T\u0101s ne tikai padara sevi neatpaz\u012bstamu k\u0101 ienaidnieku, bet ar\u012b tik \u013coti nodarbina im\u016bnsist\u0113mu, ka p\u0113c zin\u0101ma laika t\u0101 iztuk\u0161ojas un, iesp\u0113jams, pat izple\u0161 sp\u0101rnus - un padodas v\u0113zim.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Was_Immunzelltherapie_macht\"><\/span>Ko dara im\u016bn\u0161\u016bnu terapija<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Im\u016bn\u0161\u016bnu terapij\u0101 im\u016bn\u0161\u016bnas tiek iz\u0146emtas no pacienta, apr\u012bkotas, piem\u0113ram, ar lab\u0101ku atpaz\u012b\u0161anas tehnolo\u0123iju, liel\u0101ku kaujas sp\u0113ku vai jaunu \u201em\u0113r\u0137a optiku\u201c un atgrieztas organism\u0101, kur t\u0101s var m\u0113r\u0137tiec\u012bg\u0101k uzbrukt v\u0113zim un izn\u012bcin\u0101t to.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Das_Geniale_daran\"><\/span>T\u0101s \u0123enialit\u0101te<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>At\u0161\u0137ir\u012bb\u0101 no \u0137\u012bmijterapijas, kas princip\u0101 nogalina visu, kas \u0101tri dal\u0101s (v\u0113\u017ea \u0161\u016bnas, no vienas puses, bet ar\u012b - net\u012b\u0161i - matu \u0161\u016bnas, zarnu \u0161\u016bnas u. c.), im\u016bn\u0161\u016bnu terapija ir v\u0113rsta uz visu, kas \u0101tri dal\u0101s. <strong>tikai uz v\u0113\u017ea \u0161\u016bn\u0101m.<\/strong> - vismaz teor\u0113tiski.<\/p>\n\n\n\n<p>T\u0101 k\u0101 im\u016bnsist\u0113ma atceras atpaz\u012btos ienaidniekus, t\u0101 nekav\u0113joties uzbr\u016bk jaunaj\u0101m v\u0113\u017ea \u0161\u016bn\u0101m un izn\u012bcina t\u0101s, ja v\u0113zis atgrie\u017eas. Tas izskaidro, k\u0101p\u0113c da\u017ei pacienti p\u0113c vienas inf\u016bzijas paliek past\u0101v\u012bgi br\u012bvi no audz\u0113ja.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Die_drei_Typen_%E2%80%93_ganz_einfach\"><\/span>Tr\u012bs veidi - \u013coti vienk\u0101r\u0161i<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>1 CAR-T \u0161\u016bnas: P\u0101rveide<\/strong><br>Tiek \u0146emtas T \u0161\u016bnas (im\u016bnsist\u0113mas kaujas sp\u0113ks) un laboratorij\u0101 t\u0101m tiek ieb\u016bv\u0113ta piln\u012bgi jauna \u201esatver\u0161anas roka\u201c - m\u0101ksl\u012bgais receptoru. Tas atpaz\u012bst \u013coti specifisku iez\u012bmi uz v\u0113\u017ea \u0161\u016bnas virsmas un p\u0113c tam tie\u0161i izn\u012bcina v\u0113\u017ea \u0161\u016bnu.<\/p>\n\n\n\n<p><strong>2 TCR T \u0161\u016bnas: Lab\u0101kas brilles<\/strong><br>L\u012bdz\u012bgi k\u0101 CAR-T, m\u0101ksl\u012bg\u0101s satver\u0161anas rokas viet\u0101 T \u0161\u016bnai tiek pie\u0161\u0137irts uzlabots dabiskais receptoru, kas atpaz\u012bst ar\u012b \u012bpa\u0161\u012bbas, kuras ir dzi\u013ci saist\u012btas ar T \u0161\u016bn\u0101m. <em>iek\u0161pus\u0113<\/em> v\u0113\u017ea \u0161\u016bnas, un no \u0101rpuses ir redzami tikai nelieli fragmenti.<\/p>\n\n\n\n<p><strong>3. TIL terapija: veter\u0101ns<\/strong><br>\u0160aj\u0101 gad\u012bjum\u0101 tiek \u0146emtas T \u0161\u016bnas, kas jau ir <em>pa\u0161\u0101 audz\u0113j\u0101<\/em> un paz\u012bt vi\u0146u. T\u0101s tiek ieg\u016btas, masveid\u0101 pavairotas laboratorij\u0101 - da\u017eas \u0161\u016bnas k\u013c\u016bst par miljardiem - un nos\u016bt\u012btas atpaka\u013c pieredz\u0113ju\u0161iem \u201eveter\u0101niem\u201c.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"T-Zellen_und_ihre_Rolle\"><\/span>T \u0161\u016bnas un to loma<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Adapt\u012bv\u0101s im\u016bnsist\u0113mas pamat\u0101 ir divi galvenie \u0161\u016bnu tipi: <strong>B \u0161\u016bnas<\/strong> (antivielu ra\u017eo\u0161ana) un <strong>T-\u0161\u016bnas<\/strong> (\u0161\u016bnu imunit\u0101te). T \u0161\u016bnas, kas iedal\u0101s div\u0101s funkcion\u0101l\u0101s popul\u0101cij\u0101s, galvenok\u0101rt ir svar\u012bgas vis\u0101m im\u016bn\u0161\u016bnu terapij\u0101m:<\/p>\n\n\n\n<p><strong>CD8+ citotoksisk\u0101s T \u0161\u016bnas (CTL)<\/strong><br>Atpaz\u012bst pept\u012bdu-MHC I klases kompleksus uz infic\u0113to vai \u013caundab\u012bgo \u0161\u016bnu virsmas, izmantojot T-\u0161\u016bnu receptoru (TCR), un izraisa to apoptozi, atbr\u012bvojot perfor\u012bnu\/granz\u012bmu B vai mijiedarbojoties FasL\/Fas.<\/p>\n\n\n\n<p><strong>CD4+ pal\u012bgvielas T \u0161\u016bnas<\/strong><br>Koordin\u0113 im\u016bnsist\u0113mas atbildes reakciju, izdalot citok\u012bnus (IL-2, IFN-\u03b3, TNF-\u03b1), un ir b\u016btiski CTL atbildes reakcijas ilgtermi\u0146a notur\u012bbai.<\/p>\n\n\n\n<p><strong>Zin\u0101tniskais pamatojums:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>T-\u0161\u016bnu imunolo\u0123ijas pamatdarbi: <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK10757\/\" target=\"_blank\" rel=\"noopener\">Janeway's Immunobiology (NCBI Bookshelf)<\/a><\/li>\n\n\n\n<li>P\u0101rskats par T-\u0161\u016bnu izs\u012bk\u0161anu v\u0113\u017ea gad\u012bjum\u0101: <a href=\"https:\/\/www.nature.com\/articles\/nri3862\" target=\"_blank\" rel=\"noopener\">Wherry &amp; Kurachi, Nature Reviews Immunology 2015<\/a><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tumorimmunologie-Grundprinzip\"><\/span>Audz\u0113ju imunolo\u0123ijas pamatprincips<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>V\u0113zis neatt\u012bst\u0101s imunolo\u0123isk\u0101 vakuum\u0101. Uz <strong>V\u0113\u017ea im\u016bnoedit\u0101cija<\/strong>-(Dunn, Bruce &amp; Schreiber, 2004) apraksta tr\u012bs f\u0101zes:<\/p>\n\n\n\n<p><strong>Elimin\u0101cija<\/strong><br>Im\u016bnsist\u0113ma atpaz\u012bst un izn\u012bcina transform\u0113t\u0101s \u0161\u016bnas, izmantojot ar audz\u0113ju saist\u012btos antig\u0113nus (TAA) un audz\u0113jam specifiskos antig\u0113nus (TSA). MHC-I medi\u0113ta mut\u0113to pept\u012bdu prezent\u0101cija aktiviz\u0113 CTL.<\/p>\n\n\n\n<p><strong>L\u012bdzsvars<\/strong><br>Im\u016bnsist\u0113ma uztur l\u012bdzsvaru audz\u0113ju aug\u0161an\u0101, bet vienlaikus atlasa im\u016bnrezistentus variantus.<\/p>\n\n\n\n<p><strong>Aizb\u0113gt<\/strong><br>V\u0113\u017ea \u0161\u016bnas izgl\u0101bjas, pazeminot MHC-I regul\u0101ciju, p\u0101rm\u0113r\u012bgi ekspres\u0113jot im\u016bnsist\u0113mas kontrolpunktus (PD-L1, CTLA-4 ligandi), izdalot imunosupres\u012bvus citok\u012bnus (TGF-\u03b2, IL-10) un rekrut\u0113jot regul\u0113jo\u0161\u0101s T \u0161\u016bnas (Tregs).<\/p>\n\n\n\n<p><strong>Zin\u0101tniskais pamatojums:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.cell.com\/immunity\/fulltext\/S1074-7613(02)00272-3\" target=\"_blank\" rel=\"noopener\">Dunn et al, Immunity 2002<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.cell.com\/immunity\/fulltext\/S1074-7613(13)00272-X\" target=\"_blank\" rel=\"noopener\">Chen &amp; Mellman, Immunity 2013 - V\u0113\u017ea imunit\u0101tes cikls<\/a><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CAR-T-Zelltherapie_%E2%80%93_Konstruktion_und_Mechanismus\"><\/span>CAR-T \u0161\u016bnu terapija - dizains un meh\u0101nisms<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Molekularer_Aufbau_des_CAR\"><\/span>CAR molekul\u0101r\u0101 strukt\u016bra<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Him\u0113riskais antig\u0113na receptoru (CAR) ir sint\u0113tisks transmembr\u0101nas prote\u012bns ar \u010detriem funkcion\u0101liem dom\u0113niem:<\/p>\n\n\n\n<p><strong>1. ekstracelul\u0101r\u0101s saist\u012b\u0161an\u0101s dom\u0113ns<\/strong><br>Galvenok\u0101rt a <strong>scFv<\/strong> (monoklon\u0101l\u0101s antivielas vienas \u0137\u0113des main\u012bgais fragments). Tie\u0161i saist\u0101s ar virsmas antig\u0113nu (piem., CD19 B \u0161\u016bn\u0101s, BCMA plazmas \u0161\u016bn\u0101s) MHC neatkar\u012bg\u0101 veid\u0101. \u0160\u012b MHC neatkar\u012bba ir b\u016btiska at\u0161\u0137ir\u012bba no dabisk\u0101 TCR.<\/p>\n\n\n\n<p><strong>2. viru\/saite\u0146u re\u0123ions<\/strong><br>Elast\u012bgs starpposms starp saist\u012b\u0161anas dom\u0113nu un \u0161\u016bnu membr\u0101nu (piem\u0113ram, IgG4-Hinge, CD8\u03b1-Hinge). Garums un elast\u012bgums b\u016btiski ietekm\u0113 saist\u012b\u0161an\u0101s efektivit\u0101ti.<\/p>\n\n\n\n<p><strong>3. transmembr\u0101nas dom\u0113ns<\/strong><br>Nostiprina CAR T \u0161\u016bnas membr\u0101n\u0101; ietekm\u0113 sign\u0101la stabilit\u0101ti.<\/p>\n\n\n\n<p><strong>4. intracelul\u0101rais signaliz\u0101cijas dom\u0113ns<\/strong><br>Sast\u0101v no prim\u0101r\u0101 aktiv\u0101cijas dom\u0113na (CD3\u03b6 ar 3 ITAM) + kostimul\u0101cijas dom\u0113niem. Ko-stimul\u0113jo\u0161ie dom\u0113ni nosaka <strong>CAR \u0123ener\u0113\u0161ana:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Generation<\/th><th>Ko-stimul\u0101cija<\/th><th>Funkcija<\/th><\/tr><\/thead><tbody><tr><td>1. dzimums<\/td><td>Tikai CD3\u03b6<\/td><td>\u012aslaic\u012bga, v\u0101ja prolifer\u0101cija<\/td><\/tr><tr><td>2. paaudzes<\/td><td>CD28 <strong>vai<\/strong> 4-1BB (CD137) + CD3\u03b6<\/td><td>Standarta \u0161odien; Kymriah=4-1BB; Yescarta=CD28<\/td><\/tr><tr><td>3. paaudze<\/td><td>CD28 <strong>un<\/strong> 4-1BB + CD3\u03b6<\/td><td>Sp\u0113c\u012bg\u0101ka aktiviz\u0101cija, paaugstin\u0101ts CRS risks<\/td><\/tr><tr><td>4. paaudze<\/td><td>2. g\u0113ns + transg\u0113ns (piem\u0113ram, IL-12, IL-15).<\/td><td>\u201eBru\u0146otais CAR\u201c, uzlabota audz\u0113ja mikrovide<\/td><\/tr><tr><td>5. paaudze<\/td><td>2. g\u0113ns + intracelul\u0101rais IL-2R\u03b2 dom\u0113ns<\/td><td>Jagged-CAR; JAK-STAT signaliz\u0101cijas ce\u013c\u0161<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>4-1BB pret CD28 ko-stimul\u0101ciju<\/strong><br>4-1BB-CAR (Kymriah) uzr\u0101da lab\u0101ku ilgtermi\u0146a notur\u012bbu un maz\u0101ku izsmel\u0161anu (maz\u0101ku T-\u0161\u016bnu izsmel\u0161anu), CD28-CAR (Yescarta) uzr\u0101da \u0101tr\u0101ku s\u0101kotn\u0113jo aktiviz\u0101ciju un augst\u0101ku agr\u012bn\u0101s atbildes reakcijas l\u012bmeni, bet atbildes reakcija parasti ir \u012bs\u0101ka.<\/p>\n\n\n\n<p><strong>Zin\u0101tniskais pamatojums:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>B\u016bvniec\u012bbas p\u0101rskats CAR: <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMra1706169\" target=\"_blank\" rel=\"noopener\">June &amp; Sadelain, NEJM 2018<\/a><\/li>\n\n\n\n<li>4-1BB un CD28 sal\u012bdzin\u0101jums: <a href=\"https:\/\/www.nature.com\/articles\/s41591-018-0087-0\" target=\"_blank\" rel=\"noopener\">Salter et al, Nature Medicine 2018<\/a><\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Herstellungsprozess_Autolog\"><\/span>Ra\u017eo\u0161anas process (autologs)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p><strong>Leukafer\u0113ze<\/strong><br>Vien\u0161\u016bnas asins \u0161\u016bnu sav\u0101k\u0161ana no pacienta asin\u012bm, veicot \u0161\u016bnu atdal\u012b\u0161anu 3-5 stundu laik\u0101.<\/p>\n\n\n\n<p><strong>T-\u0161\u016bnu aktiviz\u0101cija<\/strong><br>Ex vivo stimul\u0101cija ar anti-CD3\/anti-CD28 antiviel\u0101m p\u0101rkl\u0101t\u0101m lod\u012bt\u0113m vai rekombinantiem ligandiem; IL-2 un IL-7\/IL-15 pievieno\u0161ana prolifer\u0101cijas veicin\u0101\u0161anai.<\/p>\n\n\n\n<p><strong>G\u0113nu p\u0101rnese<\/strong><br>CAR g\u0113na ievie\u0161ana, izmantojot:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u013bentiv\u012brusu vektors<\/strong> (Kymriah, Breyanzi): Stabila integr\u0101cija saimnieka genom\u0101; ilgtermi\u0146a ekspresija.<\/li>\n\n\n\n<li><strong>Gammaretrov\u012brusu vektors<\/strong> (Yescarta, Tecartus): L\u012bdz\u012bgs, bet liel\u0101ks insercijas mutagen\u0113zes risks.<\/li>\n\n\n\n<li><strong>Transpozonu sist\u0113mas \/ mRNS<\/strong> (eksperiment\u0101li): Neintegr\u0113jo\u0161as alternat\u012bvas<\/li>\n<\/ul>\n\n\n\n<p><strong>Papla\u0161in\u0101\u0161ana<\/strong><br>Transduc\u0113to \u0161\u016bnu pavairo\u0161ana 7-14 dienu laik\u0101 l\u012bdz parasti 10\u2078-10\u2079 \u0161\u016bnu.<\/p>\n\n\n\n<p><strong>Kvalit\u0101tes kontrole<\/strong><br>CAR transdukcijas efektivit\u0101tes, sterilit\u0101tes, atliku\u0161o komponentu, T-\u0161\u016bnu fenotipa, potences tests.<\/p>\n\n\n\n<p><strong>Kriokonserv\u0113\u0161ana un transport\u0113\u0161ana<\/strong><br>uz \u0101rstniec\u012bbas centru.<\/p>\n\n\n\n<p><strong>Limfodezerv\u0113\u0161ana<\/strong><br>2-7 dienas pirms CAR-T inf\u016bzijas pacients sa\u0146em \u0137\u012bmijterapiju (parasti fludarab\u012bnu + ciklofosfam\u012bdu), lai samazin\u0101tu organisma im\u016bno \u0161\u016bnu daudzumu un rad\u012btu \u201etelpu\u201c (limfodepleks\u012bva kondicion\u0113\u0161ana). \u0160is solis iev\u0113rojami palielina CAR-T \u0161\u016bnu prolifer\u0101ciju un notur\u012bbu, izmantojot homeostatisko IL-7\/IL-15 signaliz\u0101ciju.<\/p>\n\n\n\n<p><strong>Inf\u016bzija<\/strong><br>CAR-T \u0161\u016bnu vienreiz\u0113ja intravenoza inf\u016bzija.<\/p>\n\n\n\n<p><strong>Zin\u0101tnisk\u0101 pamatinform\u0101cija:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Limfod\u0113ljeksijas meh\u0101nisms: <a href=\"https:\/\/www.nature.com\/articles\/nm1263\" target=\"_blank\" rel=\"noopener\">Gattinoni et al, Nature Medicine, 2005. gads.<\/a><\/li>\n\n\n\n<li>Ra\u017eo\u0161anas p\u0101rskats: <a href=\"https:\/\/www.cell.com\/molecular-therapy-family\/molecular-therapy\/fulltext\/S1525-0016(16)45462-1\" target=\"_blank\" rel=\"noopener\">Levine et al, Molecular Therapy 2017<\/a><\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Wirkmechanismus_Effektorphase\"><\/span>Iedarb\u012bbas meh\u0101nisms un efektora f\u0101ze<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>P\u0113c inf\u016bzijas CAR-T \u0161\u016bnas uz audz\u0113ja \u0161\u016bn\u0101m atpaz\u012bst m\u0113r\u0137a antig\u0113nu, t\u0101d\u0113j\u0101di veidojas imunolo\u0123isk\u0101 sinaps\u0113: CAR saist\u0101s ar antig\u0113nu \u2192 CD3\u03b6-ITAM tiek fosforil\u0113ti \u2192 ZAP-70\/Lck kin\u0101\u017eu kask\u0101de \u2192 NF-\u03baB, NFAT, AP-1 aktiv\u0101cija \u2192 perfor\u012bna\/granz\u012bma B izdal\u012b\u0161an\u0101s (tie\u0161a citol\u012bze) + IFN-\u03b3, TNF-\u03b1 (citok\u012bnu sekr\u0113cija).<\/p>\n\n\n\n<p>Paral\u0113li: <strong>Bystander aktiviz\u0113\u0161ana<\/strong> - izdal\u012btie citok\u012bni aktiviz\u0113 citas endog\u0113n\u0101s im\u016bn\u0101s \u0161\u016bnas un var izrais\u012bt citok\u012bnu izdal\u012b\u0161an\u0101s sindromu (CRS).<\/p>\n\n\n\n<p><strong>Zin\u0101tne:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>CAR-T darb\u012bbas meh\u0101nisms: <a href=\"https:\/\/www.science.org\/doi\/10.1126\/science.aam8871\" target=\"_blank\" rel=\"noopener\">Lim &amp; June, Zin\u0101tne 2017<\/a><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"TCR-T-Zelltherapie_Die_entscheidenden_Unterschiede\"><\/span>TCR-T \u0161\u016bnu terapija: galven\u0101s at\u0161\u0137ir\u012bbas<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Warum_TCR_und_nicht_CAR_fur_intrazellulare_Antigene\"><\/span>K\u0101p\u0113c TCR, nevis CAR attiec\u012bb\u0101 uz intracelul\u0101rajiem antig\u0113niem?<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>CAR receptori atpaz\u012bst tikai <strong>Virsmas olbaltumvielas<\/strong>. Tom\u0113r, t\u0101 k\u0101 liel\u0101k\u0101 da\u013ca audz\u0113jiem specifisko antig\u0113nu ir lokaliz\u0113ti intracelul\u0101ri (transkripcijas faktori, metabolisma enz\u012bmi, v\u0113\u017ea s\u0113klinieku antig\u0113ni, piem\u0113ram, PRAME, MAGE-A4), CAR-T \u0161os m\u0113r\u0137us neredz\u0113s.<\/p>\n\n\n\n<p>Dabiskajam TCR piem\u012bt sp\u0113ja atpaz\u012bt intracelul\u0101r\u0101s olbaltumvielas, jo \u0161\u016bnu olbaltumvielas past\u0101v\u012bgi atpaz\u012bst. <strong>Proteazoma<\/strong> tiek sadal\u012bti l\u012bdz ~8-11 aminosk\u0101bju gariem pept\u012bdiem. \u0160ie pept\u012bdi tiek sadal\u012bti endoplazmatiskaj\u0101 retikul\u0101 l\u012bdz <strong>MHC I klases molekulas (HLA cilv\u0113kiem).<\/strong> un transport\u0113ti uz \u0161\u016bnas virsmas. Tur t\u0101s saist\u0101s ar \u03b1\u03b2-TCR, kas ir meh\u0101nisms, kur\u0161 ir akt\u012bvs vis\u0101s kodol\u0161\u016bn\u0101s.<\/p>\n\n\n\n<p><strong>TCR terapijas tehniskais izaicin\u0101jums<\/strong> ir nepiecie\u0161amais HLA ierobe\u017eojums: dabiskais augstas afinit\u0101tes TCR atpaz\u012bst specifisku pept\u012bdu tikai saist\u012bb\u0101 ar specifisku HLA al\u0113li (piem\u0113ram, HLA-A*02:01, kas sastopama aptuveni 40-50 % Kauk\u0101za iedz\u012bvot\u0101ju vid\u016b). Tas noz\u012bm\u0113, ka pacientiem ir j\u0101b\u016bt gan HLA sader\u012bgiem, gan pozit\u012bviem attiec\u012bb\u0101 uz m\u0113r\u0137a antig\u0113nu.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Struktur_des_therapeutischen_TCR\"><\/span>Terapeitisk\u0101 TCR strukt\u016bra<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Terapeitiskie TCR liel\u0101koties ir <strong>\u03b1\u03b2-TCR heterodim\u0113ri<\/strong>, kas:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Izstr\u0101d\u0101ts, izmantojot f\u0101gu displeju vai pe\u013cu humaniz\u0101ciju, ar \u0101rk\u0101rt\u012bgi augstu afinit\u0101ti (KD pM diapazon\u0101). Dabiskajam TCR ir tikai vid\u0113ja afinit\u0101te (\u03bcM), jo p\u0101r\u0101k augsta afinit\u0101te izrais\u012btu autoimunit\u0101ti.<\/li>\n\n\n\n<li>Stabiliz\u0113ti pret nejau\u0161u savieno\u0161anu ar endog\u0113naj\u0101m TCR \u0137\u0113d\u0113m, izmantojot mur\u012bnu aizvietot\u0101ju vai disulf\u012bdu tilti\u0146us.<\/li>\n\n\n\n<li>ievad\u012bt pacienta T \u0161\u016bn\u0101s, izmantojot lentiv\u012brusu transdukciju.<\/li>\n<\/ul>\n\n\n\n<p><strong>Zin\u0101tne:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>TCR afinit\u0101tes in\u017eenierija: <a href=\"https:\/\/www.jimmunol.org\/content\/180\/9\/6116\" target=\"_blank\" rel=\"noopener\">Robbins et al, Journal of Immunology, 2008. gads.<\/a><\/li>\n\n\n\n<li>Meh\u0101nisma p\u0101rskats TCR-T: <a href=\"https:\/\/aacrjournals.org\/cancerimmunolres\/article\/7\/8\/1236\/469286\" target=\"_blank\" rel=\"noopener\">Dangaj et al, Cancer Immunology Research 2019<\/a><\/li>\n\n\n\n<li>MAGE-A4 TCR b\u0101ze Tecelra: <a href=\"https:\/\/aacrjournals.org\/clincancerres\/article\/25\/24\/7537\/82286\" target=\"_blank\" rel=\"noopener\">Kageyama et al, Clin Cancer Research 2019<\/a><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"TIL-Therapie_%E2%80%93_Prinzip_der_naturlichen_Tumorerkennung\"><\/span>TIL terapija - dabisk\u0101 audz\u0113ja atkl\u0101\u0161anas princips<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Biologische_Grundlage\"><\/span>Biolo\u0123iskais pamats<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Audz\u0113ji ir infiltr\u0113ti ar im\u016bn\u0161\u016bn\u0101m. <strong>audz\u0113ju infiltr\u0113jo\u0161ie limfoc\u012bti (TIL).<\/strong>. \u0160\u012bs T \u0161\u016bnas jau ir atpazinu\u0161as audz\u0113ju, bet bie\u017ei vien ir izsmeltas, aner\u0123iskas vai to ir p\u0101r\u0101k maz, jo audz\u0113ja mikrovide (TME) ir im\u016bnsupres\u012bva. Liels TIL bl\u012bvums audz\u0113j\u0101 korel\u0113 ar lab\u0101ku prognozi daudzu v\u0113\u017ea veidu gad\u012bjum\u0101.<\/p>\n\n\n\n<p>TIL terapijas ideja (ko 80. gados izstr\u0101d\u0101ja St\u012bvens Rozenbergs (Steven Rosenberg) NCI, Bethesda, 80. gados): TIL (TIL, kas jau ir specifiskas audz\u0113jam, tiek izmantotas, atbr\u012bvotas no im\u016bnsupres\u012bv\u0101s vides, masveid\u0101 aktiviz\u0113tas un pavairotas ex vivo un atgrie\u017eas tik liel\u0101 skait\u0101, ka t\u0101s k\u013c\u016bst terapeitiski efekt\u012bvas, neraugoties uz tendenci izsmelties.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Herstellungsprozess_Lifileucel\"><\/span>Ra\u017eo\u0161anas process (Lifileucel)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p><strong>Audz\u0113ja izgrie\u0161ana<\/strong><br>Vismaz 1,5 cm\u00b3 audz\u0113ja audu tiek iz\u0146emti \u0137irur\u0123iski un nekav\u0113joties apstr\u0101d\u0101ti. <a href=\"https:\/\/www.iovance.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">Iovance Biotherapeutics, Inc.<\/a> nos\u016bt\u012bts.<\/p>\n\n\n\n<p><strong>S\u0101kotn\u0113j\u0101 papla\u0161in\u0101\u0161ana (aptuveni 11 dienas)<\/strong><br>Audz\u0113js tiek meh\u0101niski un fermentat\u012bvi disoci\u0113ts; TIL kultiv\u0113 IL-2 kl\u0101tb\u016btn\u0113 \u2192 Pre-REP (Pre-Rapid Expansion Protocol).<\/p>\n\n\n\n<p><strong>\u0100tr\u0101 papla\u0161in\u0101\u0161an\u0101s (aptuveni 11 dienas)<\/strong><br>TIL tiek apstr\u0101d\u0101ti ar anti-CD3 antiviel\u0101m (OKT3), apstarot\u0101m alog\u0113n\u0101m PBMC (kas darbojas k\u0101 antig\u0113nu prezent\u0113jo\u0161\u0101s \u0161\u016bnas) un IL-2, lai <strong>&gt;7,5 \u00d7 10\u2079 \u0161\u016bnu<\/strong> papla\u0161in\u0101s (no da\u017eiem miljoniem l\u012bdz miljardiem).<\/p>\n\n\n\n<p><strong>Limfodelekcija un inf\u016bzija<\/strong><br>L\u012bdz\u012bgi k\u0101 CAR-T: Flu\/Cy kondicion\u0113\u0161ana, p\u0113c tam vienreiz\u0113ja TIL inf\u016bzija, kam seko IL-2 ievad\u012b\u0161ana t\u0101l\u0101kai in vivo papla\u0161in\u0101\u0161anai.<\/p>\n\n\n\n<p><strong>Termi\u0146\u0161<\/strong><br>Aptuveni 22 dienas; kopum\u0101 no audz\u0113ja iz\u0146em\u0161anas l\u012bdz inf\u016bzijai aptuveni 6-7 ned\u0113\u013cas.<\/p>\n\n\n\n<p><strong>Zin\u0101tne:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Rozenberga novatoriskais darbs: <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJM198812223192529\" target=\"_blank\" rel=\"noopener\">Rosenberg et al, NEJM 1988<\/a><\/li>\n\n\n\n<li>Lifileucel 2. f\u0101zes pamatp\u0113t\u012bjums (C-144-01): <a href=\"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.21.02179\" target=\"_blank\" rel=\"noopener\">Chesney et al, JCO 2022<\/a><\/li>\n\n\n\n<li>5 gadu nov\u0113ro\u0161ana: <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/40699950\/\" target=\"_blank\" rel=\"noopener\">PubMed FDA apstiprin\u0101juma kopsavilkums 2024<\/a><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Herausforderungen_%E2%80%93_aktuelle_Forschungsansatze\"><\/span>Izaicin\u0101jumi - pa\u0161reiz\u0113j\u0101s p\u0113tniec\u012bbas pieejas<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Antigen-Escape\"><\/span>Antig\u0113na izk\u013c\u016b\u0161ana<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p><strong>Probl\u0113mas defin\u012bcija<\/strong><br>Audz\u0113ja \u0161\u016bnas var samazin\u0101t vai zaud\u0113t m\u0113r\u0137a antig\u0113na ekspresiju. CD19-CAR-T gad\u012bjum\u0101 CD19-negat\u012bvs recid\u012bvs rodas 30-40 % gad\u012bjumu.<\/p>\n\n\n\n<p><strong>Risin\u0101jums<\/strong><br>Du\u0101l\u0101s m\u0113r\u0137\u0113\u0161anas strat\u0113\u0123ijas (CD19+CD22, BCMA+CD38), tand\u0113mu CAR, lo\u0123isko v\u0101rtu CAR (AND v\u0101rti: nepiecie\u0161ami divi antig\u0113ni; NOT v\u0101rti: nogalina tikai \u0161\u016bnas bez aizsarg\u0101jo\u0161\u0101 antig\u0113na).<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.nature.com\/articles\/nm.4164\" target=\"_blank\" rel=\"noopener\">Ruella et al, Nature Medicine 2016 (CD19-Escape)<\/a><\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"T-Zell-Erschopfung_Exhaustion\"><\/span>T-\u0161\u016bnu izs\u012bkums (izs\u012bkums)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p><strong>Probl\u0113mas defin\u012bcija<\/strong><br>Audz\u0113ja \u0161\u016bnas var samazin\u0101t vai zaud\u0113t m\u0113r\u0137a antig\u0113na ekspresiju. CD19-CAR-T gad\u012bjum\u0101 CD19-negat\u012bvs recid\u012bvs rodas 30-40 % gad\u012bjumu.<\/p>\n\n\n\n<p>Hroniska antig\u0113nu iedarb\u012bba \u2192 Izs\u012bkuma mar\u0137ieru (PD-1, TIM-3, LAG-3, TOX transkripcijas faktors) ekspresija \u2192 Funkcijas zudums.<\/p>\n\n\n\n<p><strong>Risin\u0101jums:<\/strong> Kombin\u0101cija ar kontrolpunktu inhibitoriem, epi\u0123en\u0113tiska p\u0101rprogramm\u0113\u0161ana, izmantojot TET2 nom\u0101k\u0161anu, n\u0101kam\u0101s paaudzes CAR mode\u013ci ar ieb\u016bv\u0113tu kontrolpunktu blok\u0101di.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.nature.com\/articles\/s41586-019-1546-z\" target=\"_blank\" rel=\"noopener\">Chen et al, Nature 2019 (TET2 nokaut\u0113\u0161ana)<\/a><\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tumormikroumgebung_TME\"><\/span>Audz\u0113ja mikrovide (TME)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p><strong>Probl\u0113mas defin\u012bcija<\/strong><br>Audz\u0113ja \u0161\u016bnas var samazin\u0101t vai zaud\u0113t m\u0113r\u0137a antig\u0113na ekspresiju. CD19-CAR-T gad\u012bjum\u0101 CD19-negat\u012bvs recid\u012bvs rodas 30-40 % gad\u012bjumu.<\/p>\n\n\n\n<p>Cietajiem audz\u0113jiem ir naid\u012bga mikrovide: hipoksija, glikozes defic\u012bts, imunosupres\u012bvi citok\u012bni (TGF-\u03b2, IL-10), Tregs, MDSC.<\/p>\n\n\n\n<p><strong>Risin\u0101jums<\/strong><br>Bru\u0146oti CAR ar IL-12\/IL-15\/IL-18 sekr\u0113ciju, PD-1 rezistenti CAR, kombin\u0101cija ar anti-VEGF, lok\u0101las intratumor\u0101las injekcijas.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.nature.com\/articles\/s41598-017-10259-0\" target=\"_blank\" rel=\"noopener\">Yeku et al, Scientific Reports 2017 (bru\u0146otie automobi\u013ci)<\/a><\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Zytokinsturm_CRS_ICANS\"><\/span>Citok\u012bnu v\u0113tra (CRS) un ICANS<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p><strong>Probl\u0113mas defin\u012bcija<\/strong><br>CRS izraisa masveida citok\u012bnu (IL-6, IFN-\u03b3, IL-1\u03b2) izdal\u012b\u0161an\u0101s no aktiv\u0113tiem CAR-T un makrof\u0101giem. Smagas pak\u0101pes CRS (3.-4. pak\u0101pes) gad\u012bjum\u0101 nepiecie\u0161ama intens\u012bva terapija. ICANS (neirolo\u0123iska toksicit\u0101te) rodas endot\u0113lija aktiv\u0101cijas un asins-smadze\u0146u barjeras disfunkcijas d\u0113\u013c.<\/p>\n\n\n\n<p><strong>Vad\u012bba<\/strong><br>Tocilizumabs (IL-6R blok\u0101de), kortikostero\u012bdi, anakinra (IL-1 blok\u0101de); agr\u012bna iejauk\u0161an\u0101s uzlabo rezult\u0101tus.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4116524\/\" target=\"_blank\" rel=\"noopener\">Lee et al, Blood 2014 - CRS klasifik\u0101cijas sist\u0113ma<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.nature.com\/articles\/nrneurol.2018.138\" target=\"_blank\" rel=\"noopener\">Neelapu et al, Nature Reviews Neurology 2018 - ICANS<\/a><\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Allogene_%E2%80%9EOff-the-shelf%E2%80%9C-Therapien\"><\/span>Allog\u0113nisk\u0101s \u201egatav\u0101s\u201c terapijas<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p><strong>Probl\u0113mas defin\u012bcija<\/strong><br>Audz\u0113ja \u0161\u016bnas var samazin\u0101t vai zaud\u0113t m\u0113r\u0137a antig\u0113na ekspresiju. CD19-CAR-T gad\u012bjum\u0101 CD19-negat\u012bvs recid\u012bvs rodas 30-40 % gad\u012bjumu.<\/p>\n\n\n\n<p>Autolog\u0101 ra\u017eo\u0161ana ilgst 3-6 ned\u0113\u013cas un ir d\u0101rga (400 000-600 000 \u20ac).<\/p>\n\n\n\n<p><strong>Risin\u0101jums<\/strong><br>Alog\u0113niska CAR-T no veseliem donoriem ar endog\u0113n\u0101 TCR (GvHD profilakse) un HLA komponentu (atme\u0161anas profilakse) izsl\u0113g\u0161anu ar CRISPR.<\/p>\n\n\n\n<p><strong>Pa\u0161reiz\u0113jie dati<\/strong><br>CTX112 (CRISPR-allogeneic CD19-CAR-T) 1. f\u0101z\u0113 uzr\u0101da pirm\u0101s piln\u012bgas remisijas CLL.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.science.org\/doi\/10.1126\/science.abb4845\" target=\"_blank\" rel=\"noopener\">Stadtmauer et al, Science 2020 - CRISPR CAR-T 1. f\u0101ze<\/a><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"27_Quantitative_Wirksamkeitsdaten_im_Uberblick\"><\/span>2.7 Kvantitat\u012bvie efektivit\u0101tes dati \u012bsum\u0101<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Terapija<\/th><th>Nor\u0101de<\/th><th>ORR<\/th><th>CR likme<\/th><th>OS medi\u0101na<\/th><th>Avots:<\/th><\/tr><\/thead><tbody><tr><td>Tisag\u0113nkleicels<\/td><td>B-ALL pediatrijas<\/td><td>81 %<\/td><td>60 %<\/td><td>NR (63 % 12 m\u0113ne\u0161u laik\u0101)<\/td><td>NEJM 2018<\/td><\/tr><tr><td>Axicabtagene-cel<\/td><td>DLBCL 3. l\u012bnija<\/td><td>83 %<\/td><td>58 %<\/td><td>NR (74 % 12 m\u0113ne\u0161u laik\u0101)<\/td><td>NEJM 2017<\/td><\/tr><tr><td>Ciltacabtagene-cel<\/td><td>Mult. mieloma<\/td><td>98 %<\/td><td>78 %<\/td><td>NR (&gt;80 % 12 m\u0113ne\u0161u laik\u0101)<\/td><td>Lancet 2021<\/td><\/tr><tr><td>Lifileucel<\/td><td>Melanoma<\/td><td>31,4 %<\/td><td>7,5 %<\/td><td>NR (49 % 24 m\u0113ne\u0161u laik\u0101)<\/td><td>JCO 2022<\/td><\/tr><tr><td>Afamitresgene-cel<\/td><td>Sinovi\u0101l\u0101 sarkoma<\/td><td>43 %<\/td><td>4 %<\/td><td>16,4 m\u0113ne\u0161i<\/td><td>Lancet 2024<\/td><\/tr><tr><td>Tebentafusp<\/td><td>Uve\u0101l\u0101 melanoma<\/td><td>9 % (ORR)<\/td><td>&lt;1 %<\/td><td>21,7 m\u0113ne\u0161i<\/td><td>NEJM 2021<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><em>(NR = nav sasniegts; OS* v\u0113l nav sasniegts)<\/em><\/p>\n\n\n\n<p>*<em>OS<\/em> (<em>Kop\u0113jais izdz\u012bvo\u0161anas ilgums<\/em>\u00a0) - piem\u0113ram, \u201e<em>OS medi\u0101na 21,7<\/em>\u201e puse pacientu bija miru\u0161i p\u0113c 21,7 m\u0113ne\u0161iem, bet otra puse joproj\u0101m bija dz\u012bva.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Weiterfuhrende_Literatur_Ressourcen\"><\/span>Papildu las\u0101mviela un resursi<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>Atsauksmes:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.science.org\/doi\/10.1126\/science.aar6711\" target=\"_blank\" rel=\"noopener\">June et al, Science 2018 - CAR-T terapijas p\u0101rskats<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/link.springer.com\/article\/10.1007\/s00428-019-02571-3\" target=\"_blank\" rel=\"noopener\">Rohaan et al, Virchows Arch 2019 - TIL terapijas p\u0101rskats<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.nature.com\/articles\/s41586-019-1840-9\" target=\"_blank\" rel=\"noopener\">Stadtmauer et al, Nature 2020 - Allogenisk\u0101 TCR\/CAR-T<\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>Vadl\u012bnijas un datub\u0101zes:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/clinicaltrials.gov\/search?term=CAR-T+OR+TIL+OR+TCR-T&amp;recency=5\" target=\"_blank\" rel=\"noopener\">ClinicalTrials.gov - visi notieko\u0161ie im\u016bn\u0161\u016bnu terapijas p\u0113t\u012bjumi<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.cancer.gov\/about-cancer\/treatment\/types\/immunotherapy\/t-cell-transfer-therapy\" target=\"_blank\" rel=\"noopener\">NCI - Im\u016bnterapijas p\u0101rskats<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.dgho.de\/informationen\/stellungnahmen\/gute-wissenschaftliche-praxis\/car-t-zellen\" target=\"_blank\" rel=\"noopener\">V\u0101cijas Hematologu biedr\u012bba (DGHO) - CAR-T terapija<\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>Pacientiem draudz\u012bgi resursi (v\u0101cu valod\u0101):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.krebshilfe.de\/informieren\/ueber-krebs\/therapie\/immuntherapie\/\" target=\"_blank\" rel=\"noopener\">Krebshilfe Deutschland - Im\u016bnterapijas skaidrojums<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.kitz-heidelberg.de\/forschungsprogramme\/zell-und-gentherapie\/\" target=\"_blank\" rel=\"noopener\">KiTZ Heidelberg - Pacienti un im\u016bnterapija<\/a><\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><em>Nepilnu desmit gadu laik\u0101 im\u016bn\u0161\u016bnu terapija no eksperiment\u0101las koncepcijas ir p\u0101rtapusi par standarta kl\u012bnisko terapiju, un apstiprin\u0101to produktu un indik\u0101ciju skaits turpina strauji pieaugt. Pacientiem, kuriem t\u0101 ir piem\u0113rota, t\u0101 var b\u016bt vien\u012bg\u0101 potenci\u0101li \u0101rstniecisk\u0101 iesp\u0113ja.<\/em><\/p>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Weltweit_zugelassene_Immunzelltherapien\"><\/span>Pasaul\u0113 apstiprin\u0101tas im\u016bn\u0161\u016bnu terapijas<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Statuss 02.2026<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Einleitung_Die_drei_grosen_Klassen\"><\/span>Ievads: Tr\u012bs galven\u0101s klases<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>M\u016bsdien\u0101s termins \u201eim\u016bn\u0161\u016bnu terapija\u201c onkolo\u0123ijas kontekst\u0101 aptver tr\u012bs da\u017e\u0101das produktu kategorijas:<\/p>\n\n\n\n<p><strong>1. CAR-T \u0161\u016bnu terapija<\/strong> (him\u0113risko antig\u0113nu receptoru T-\u0161\u016bnas)<br>\u0122en\u0113tiski modific\u0113tas T \u0161\u016bnas ar sint\u0113tisku virsmas receptoru, kas atpaz\u012bst audz\u0113ja antig\u0113nus uz \u0161\u016bnu virsmas. Visi l\u012bdz \u0161im apstiprin\u0101tie produkti ir v\u0113rsti pret CD19 vai BCMA un ir at\u013cauti asins v\u0113\u017ea \u0101rst\u0113\u0161anai.<\/p>\n\n\n\n<p><strong>2. TCR-T \u0161\u016bnu terapija<\/strong> (T-\u0161\u016bnu receptoru T-\u0161\u016bnas)<br>\u0122en\u0113tiski modific\u0113tas T \u0161\u016bnas ar optimiz\u0113tu dabisko T \u0161\u016bnu receptoru, kas atpaz\u012bst iek\u0161\u0161\u016bnu audz\u0113ju prote\u012bnus, kas atrodas HLA kompleks\u0101. Pirmo reizi apstiprin\u0101ts cietajiem audz\u0113jiem 2024. gad\u0101.<\/p>\n\n\n\n<p><strong>3. TIL terapija<\/strong> (audz\u0113ju infiltr\u0113jo\u0161ie limfoc\u012bti)<br>\u0122en\u0113tiski nemodific\u0113tas T \u0161\u016bnas, kas ieg\u016btas no pacienta audz\u0113ja, masveid\u0101 pavairotas un atk\u0101rtoti ievad\u012btas. Pirmo reizi apstiprin\u0101ts melanomas \u0101rst\u0113\u0161anai 2024. gad\u0101.<\/p>\n\n\n\n<p>2024. gada decembr\u012b FDA bija apstiprin\u0101jusi se\u0161as CAR-T \u0161\u016bnu terapijas, un pasaul\u0113 bija komerci\u0101li pieejamas desmit CAR-T \u0161\u016bnu terapijas. Turkl\u0101t ir pieejama TIL terapija (Lifileucel) un TCR terapija (Afamitresgene autoleucel) - pirm\u0101s sav\u0101 klas\u0113, kas paredz\u0113tas stabiliem audz\u0113jiem. <a href=\"https:\/\/www.curemelanoma.org\/blog\/melanoma-clinical-trials-to-watch-fall-2025\" target=\"_blank\" rel=\"noreferrer noopener\">MRA<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CAR-T-ZELLTHERAPIEN\"><\/span>CAR-T \u0160\u016aNU TERAPIJA<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tisagenlecleucel_Kymriah%C2%AE_%E2%80%93_Novartis\"><\/span>Tisag\u0113nkleicels (Kymriah\u00ae) - <em>Novartis<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>M\u0113r\u0137a antig\u0113ns:<\/strong> CD19 <br><strong>Pilnvarots:<\/strong> FDA 2017 \/ EMA 2018<br><strong>Pirmais CAR-T produkts, kas jebkad apstiprin\u0101ts vis\u0101 pasaul\u0113<\/strong><\/p>\n\n\n\n<p><strong>Indik\u0101cijas<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>B\u0113rni un jaunie\u0161i l\u012bdz 25 gadu vecumam: recidiv\u0113jusi\/refrakt\u0101ra B \u0161\u016bnu ALL (ak\u016bta limfoblastisk\u0101 leik\u0113mija)<\/li>\n\n\n\n<li>Pieaugu\u0161ie: recid\u012bv\u0113jusi\/refrakt\u0101ra lielo B \u0161\u016bnu limfoma (LBCL) p\u0113c \u2265 2 sist\u0113misk\u0101m terapij\u0101m.<\/li>\n\n\n\n<li>Atgriezusies\/refrakt\u0101ra folikul\u0101r\u0101 limfoma (FL)<\/li>\n<\/ul>\n\n\n\n<p><strong>Svar\u012bg\u0101kie p\u0113t\u012bjumi<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ELIANA p\u0113t\u012bjums (ALL pediatrij\u0101): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT02435849\" target=\"_blank\" rel=\"noopener\">NCT02435849<\/a> | <a href=\"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.21.01019\" target=\"_blank\" rel=\"noopener\">JCO 2021<\/a><\/li>\n\n\n\n<li>JULIET p\u0113t\u012bjums (LBCL): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT02445248\" target=\"_blank\" rel=\"noopener\">NCT02445248<\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>At\u013caujas pie\u0161\u0137\u012br\u0113jas iest\u0101des<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA<\/li>\n\n\n\n<li>EMA<\/li>\n\n\n\n<li>TGA (Austr\u0101lija)<\/li>\n\n\n\n<li>PMDA (Jap\u0101na) <\/li>\n<\/ul>\n\n\n\n<p><strong>Ra\u017eot\u0101js\/vietne:<\/strong> <a href=\"https:\/\/www.novartis.com\/us-en\/sites\/novartis_us\/files\/kymriah.pdf\" target=\"_blank\" rel=\"noopener\">Novartis Kymriah<\/a><\/p>\n\n\n\n<p><strong>FDA produkta lapa:<\/strong> <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/kymriah\" target=\"_blank\" rel=\"noopener\">Kymriah FDA<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Axicabtagene_Ciloleucel_Yescarta%C2%AE_%E2%80%93_KiteGilead\"><\/span>Aksicabtag\u0113ns Ciloleucel (Yescarta\u00ae) - <em>Kite\/Gilead<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>M\u0113r\u0137a antig\u0113ns:<\/strong> CD19<br><strong>Pilnvarots:<\/strong> FDA 2017. gada oktobris \/ EMA 2018. gada augusts<\/p>\n\n\n\n<p><strong>Indik\u0101cijas<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Lielo B \u0161\u016bnu limfoma (DLBCL, PMBCL, HGBCL, tFL) p\u0113c \u2265 2 sist\u0113misk\u0101m terapij\u0101m<\/li>\n\n\n\n<li>Prim\u0101ri refrakt\u0101rs DLBCL vai recid\u012bvs 12 m\u0113ne\u0161u laik\u0101 (2. l\u012bnija)<\/li>\n\n\n\n<li>Atgriezusies\/refrakt\u0101ra folikul\u0101r\u0101 limfoma p\u0113c \u2265 2 sist\u0113misk\u0101m terapij\u0101m<\/li>\n<\/ul>\n\n\n\n<p><strong>Svar\u012bg\u0101kie p\u0113t\u012bjumi<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ZUMA-1 (LBCL, ORR 82 %): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT02348216\" target=\"_blank\" rel=\"noopener\">NCT02348216<\/a> | <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa1707447\" target=\"_blank\" rel=\"noopener\">NEJM 2017<\/a><\/li>\n\n\n\n<li>ZUMA-7 (2. l\u012bnija pret ASCT): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03391466\" target=\"_blank\" rel=\"noopener\">NCT03391466<\/a><\/li>\n\n\n\n<li>ZUMA-5 (folikul\u0101r\u0101 limfoma, ORR &gt; 90 %): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03105336\" target=\"_blank\" rel=\"noopener\">NCT03105336<\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>\u0100rst\u0113\u0161anas centri (D\/A\/CH atlase)<\/strong><\/p>\n\n\n\n<p>Visi kvalific\u0113tie FACT\/JACIE akredit\u0113tie transplant\u0101cijas centri; V\u0101cij\u0101, piem\u0113ram, Universit\u0101tes Medic\u012bnas centrs Hamburg-Eppendorf, Charit\u00e9 Berlin, LMU Klinikum M\u00fcnchen, Universit\u0101tes Medic\u012bnas centrs Heidelberg.<\/p>\n\n\n\n<p><strong>Ra\u017eot\u0101js \/ t\u012bmek\u013ca vietne<\/strong>: <a href=\"https:\/\/www.yescarta.com\" target=\"_blank\" rel=\"noopener\">Gilead Yescarta<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Brexucabtagene_Autoleucel_Tecartus%C2%AE_%E2%80%93_KiteGilead\"><\/span>Brexucabtagene Autoleucel (Tecartus\u00ae) - <em>Kite\/Gilead<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>M\u0113r\u0137a antig\u0113ns:<\/strong> CD19<br><strong>Pilnvarots:<\/strong> FDA 2020. gada j\u016blijs (MCL), 2021. gada oktobris (VISIEM pieaugu\u0161ajiem) \/ EMA 2020. gada decembris<\/p>\n\n\n\n<p><strong>Indik\u0101cijas<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Atgriezusies\/refrakt\u0101ra mantijas \u0161\u016bnu limfoma (MCL) p\u0113c BTK inhibitora lieto\u0161anas<\/li>\n\n\n\n<li>Pieaugu\u0161ie ar recidiv\u0113ju\u0161u\/refrakt\u0101ru B \u0161\u016bnu ALL<\/li>\n<\/ul>\n\n\n\n<p><strong>Svar\u012bg\u0101kie p\u0113t\u012bjumi<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ZUMA-2 (MCL, OS 12 m\u0113ne\u0161i: 83 %): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT02601313\" target=\"_blank\" rel=\"noopener\">NCT02601313<\/a><\/li>\n\n\n\n<li>ZUMA-3 (pieaugu\u0161o B-ALL, OS medi\u0101na 18,2 m\u0113ne\u0161i): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT02614066\" target=\"_blank\" rel=\"noopener\">NCT02614066<\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>FDA produkta lapa:<\/strong> <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/tecartus\" target=\"_blank\" rel=\"noopener\">FDA Tecartus<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Lisocabtagene_Maraleucel_Breyanzi%C2%AE_%E2%80%93_Bristol_Myers_Squibb\"><\/span>Lisocabtag\u0113ns Maraleucel (Breyanzi\u00ae) - <em>Bristol Myers Squibb<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>M\u0113r\u0137a antig\u0113ns:<\/strong> CD19<br><strong>Pilnvarots:<\/strong> FDA 2021. gada febru\u0101ris (s\u0101kotn\u0113jais) \/ papla\u0161in\u0101t\u0101s indik\u0101cijas 2022-2024 \/ EMA 2022. gada oktobris<\/p>\n\n\n\n<p><strong>Indik\u0101cijas<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Lielo B \u0161\u016bnu limfoma (LBCL, DLBCL, HGBCL, FL) 2. + 3. l\u012bnija<\/li>\n\n\n\n<li>Hroniska limfoc\u012btisk\u0101 leik\u0113mija (CLL) \/ maz\u0161\u016bnu limfoc\u012btisk\u0101 limfoma (SLL) p\u0113c \u2265 2 terapij\u0101m, ieskaitot BTK inhibitoru (FDA 2024)<\/li>\n\n\n\n<li>Folikul\u0101r\u0101 limfoma (FL) p\u0113c \u22652 sist\u0113misk\u0101m terapij\u0101m<\/li>\n<\/ul>\n\n\n\n<p><strong>Svar\u012bg\u0101kie p\u0113t\u012bjumi<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>TRANSFORM (2. l\u012bnijas DLBCL): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03575351\" target=\"_blank\" rel=\"noopener\">NCT03575351<\/a><\/li>\n\n\n\n<li>TRANSCEND-CLL-004 (CLL\/SLL): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03331198\" target=\"_blank\" rel=\"noopener\">NCT03331198<\/a> | <a href=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(24)00422-7\/fulltext\" target=\"_blank\" rel=\"noopener\">Lancet 2024<\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>FDA produkta lapa:<\/strong> <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/breyanzi\" target=\"_blank\" rel=\"noopener\">FDA Breyanzi<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Idecabtagene_Vicleucel_Abecma%C2%AE_%E2%80%93_Bristol_Myers_Squibb_2seventy_bio\"><\/span>Idecabtagene Vicleucel (Abecma\u00ae) - <em>Bristol Myers Squibb \/ 2seventy bio<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>M\u0113r\u0137a antig\u0113ns:<\/strong> BCMA (B \u0161\u016bnu nobrie\u0161anas antig\u0113ns)<br><strong>Pilnvarots:<\/strong> FDA 2021. gada marts \/ EMA 2021. gada augusts<\/p>\n\n\n\n<p><strong>Nor\u0101de<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Atgriezusies\/refrakt\u0101ra multipl\u0101 mieloma p\u0113c \u2265 4 iepriek\u0161\u0113j\u0101m terapijas l\u012bnij\u0101m<\/li>\n<\/ul>\n\n\n\n<p><strong>Svar\u012bg\u0101kais p\u0113t\u012bjums<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>KarMMa p\u0113t\u012bjums (ORR 73 %): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03361748\" target=\"_blank\" rel=\"noopener\">NCT03361748<\/a> | <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2024850\" target=\"_blank\" rel=\"noopener\">NEJM 2021<\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>FDA produkta lapa:<\/strong> <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/abecma\" target=\"_blank\" rel=\"noopener\">FDA Abecma<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ciltacabtagene_Autoleucel_Carvykti%C2%AE_%E2%80%93_JanssenLegend_Biotech\"><\/span>Ciltacabtagene Autoleucel (Carvykti\u00ae) - <em>Janssen\/Legend Biotech<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>M\u0113r\u0137a antig\u0113ns:<\/strong> BCMA (dubult\u0101 saist\u012b\u0161ana)<br><strong>Pilnvarots:<\/strong> FDA 2022. gada febru\u0101ris (\u22654 l\u012bnijas), pagarin\u0101ts 2024. gada apr\u012blis (\u22651 l\u012bnija) \/ EMA 2022. gada maijs<\/p>\n\n\n\n<p><strong>\u012apa\u0161\u0101 funkcija:<\/strong> Unik\u0101la divu antivielu CAR ar div\u0101m BCMA saisto\u0161\u0101m vienas dom\u0113na antiviel\u0101m; tiek uzskat\u012bta par l\u012bdz \u0161im visefekt\u012bv\u0101ko apstiprin\u0101to mielomas terapiju.<\/p>\n\n\n\n<p><strong>Indik\u0101cijas<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Atgriezusies\/refrakt\u0101ra multipl\u0101 mieloma p\u0113c \u2265 4 terapijas l\u012bnij\u0101m<\/li>\n\n\n\n<li>Kop\u0161 2024. gada apr\u012b\u013ca (FDA): p\u0113c \u2265 1 terapijas l\u012bnijas lenalidom\u012bdam rezistentas slim\u012bbas gad\u012bjum\u0101.<\/li>\n<\/ul>\n\n\n\n<p><strong>Svar\u012bg\u0101kie p\u0113t\u012bjumi<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>CARTITUDE-1 (ORR 98 %, CR 78 %): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03548207\" target=\"_blank\" rel=\"noopener\">NCT03548207<\/a> | <a href=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(21)00933-4\/fulltext\" target=\"_blank\" rel=\"noopener\">Lancet 2021<\/a><\/li>\n\n\n\n<li>CARTITUDE-4 (3. f\u0101ze, 1. recid\u012bva pagarin\u0101jums): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04181827\" target=\"_blank\" rel=\"noopener\">NCT04181827<\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>FDA produkta lapa:<\/strong> <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/carvykti\" target=\"_blank\" rel=\"noopener\">P\u0101rtikas un z\u0101\u013cu p\u0101rvalde (FDA) Carvykti<\/a><br><strong>Ra\u017eot\u0101js:<\/strong> <a href=\"https:\/\/www.carvykti.com\" target=\"_blank\" rel=\"noopener\">carvykti.com<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Obecabtagene_Autoleucel_Aucatzyl%C2%AE_%E2%80%93_Autolus_neu_112024\"><\/span>Obecabtagene Autoleucel (Aucatzyl\u00ae) - <em>Autolus<\/em> <em>(jauns: 11.2024.)<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>M\u0113r\u0137a antig\u0113ns:<\/strong> CD19 (\u0101tras izvad\u012b\u0161anas \u0101truma konstrukcija - zem\u0101ka toksicit\u0101te nek\u0101 priek\u0161g\u0101j\u0113jam)<br><strong>Pilnvarots:<\/strong> FDA 2024. gada 8. novembris<\/p>\n\n\n\n<p><strong>Nor\u0101de<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pieaugu\u0161ie ar recidiv\u0113ju\u0161u\/refrakt\u0101ru B \u0161\u016bnu ALL<\/li>\n<\/ul>\n\n\n\n<p><strong>\u012apa\u0161\u0101 funkcija:<\/strong> Pirmais CAR-T produkts, kas apstiprin\u0101ts bez REMS (riska nov\u0113rt\u0113\u0161anas un mazin\u0101\u0161anas strat\u0113\u0123ijas) programmas; tas liecina par uzlabotu dro\u0161\u012bbu un jaunu CD19 saist\u012b\u0161anas koncepciju.<br><a href=\"https:\/\/www.dasgelbeblatt.de\/welt\/immunzelltherapie-heilt-ueberraschend-krebs-bei-einem-jugendlichen-zr-94168662.html\" target=\"_blank\" rel=\"noreferrer noopener\">Dzelten\u0101 lapa<\/a><\/p>\n\n\n\n<p><strong>Svar\u012bg\u0101kais p\u0113t\u012bjums<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FELIX p\u0113t\u012bjums (1\/2 f\u0101ze, CR r\u0101d\u012bt\u0101js 42 % 3 m\u0113ne\u0161u laik\u0101): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04404660\" target=\"_blank\" rel=\"noopener\">NCT04404660<\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>FDA produkta lapa:<\/strong> <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/aucatzyl\" target=\"_blank\" rel=\"noopener\">FDA Aucatzyl<\/a><br><strong>Ra\u017eot\u0101js:<\/strong> <a href=\"https:\/\/www.autolus.com\" target=\"_blank\" rel=\"noopener\">autolus.com<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"WELTWEIT_ZUGELASSEN_%E2%80%93_NICHT_IN_USAEU_weitere_Lander\"><\/span>PASAUL\u0112 PIE\u013bAUTS - NE ASV\/ES (cit\u0101s valst\u012bs)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"China_NMPA_%E2%80%93_vier_zusatzliche_CAR-T-Produkte\"><\/span>\u0136\u012bna (NMPA) - \u010detri papildu CAR-T produkti<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Pasaul\u0113 s\u0101kotn\u0113ju apstiprin\u0101jumu ir sa\u0146\u0113mu\u0161as vienpadsmit autolog\u0101s CAR-T \u0161\u016bnu terapijas. Septi\u0146as no t\u0101m ir apstiprin\u0101jusi FDA un \u010detras - \u0136\u012bnas NMPA, un t\u0101s visas ir paredz\u0113tas recid\u012bviem\/refrakt\u0101riem hematolo\u0123iskiem \u013caundab\u012bgiem audz\u0113jiem.<br><a href=\"https:\/\/ucla.clinicaltrials.researcherprofiles.org\/trial\/NCT06743126\" target=\"_blank\" rel=\"noreferrer noopener\">Immatics US, Inc.<\/a><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Tirdzniec\u012bbas nosaukums<\/th><th>Akt\u012bv\u0101 viela<\/th><th>M\u0113r\u0137a antig\u0113ns<\/th><th>Nor\u0101de<\/th><th>Autoriz\u0101cija<\/th><\/tr><\/thead><tbody><tr><td>Carteyva<\/td><td>Relmacabtagene autoleucel<\/td><td>BCMA<\/td><td>Mult. Mieloma, DLBCL<\/td><td>NMPA 2021\/2023<\/td><\/tr><tr><td>Fucaso<\/td><td>Equecabtagene autoleucel<\/td><td>BCMA<\/td><td>Mult. mieloma<\/td><td>NMPA 2023<\/td><\/tr><tr><td>Yuanruida<\/td><td>Satricabtagene autoleucel<\/td><td>CD19<\/td><td>B \u0161\u016bnu limfoma<\/td><td>NMPA<\/td><\/tr><tr><td>Zever-cel<\/td><td>\u2014<\/td><td>CD19\/BCMA<\/td><td>Hematolog.<\/td><td>NMPA<\/td><\/tr><tr><td>Carvykti<\/td><td>Ciltacabtagene autoleucel<\/td><td>BCMA<\/td><td>Mult. mieloma<\/td><td>NMPA 2024<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Indien_CDSCO\"><\/span>Indija (CDSCO)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>NexCAR19<\/strong> (Actalycabtagene autoleucel) tika apstiprin\u0101ts 2023. gada oktobr\u012b k\u0101 pirm\u0101 Indij\u0101 izstr\u0101d\u0101t\u0101 CAR-T terapija. \u0160o terapiju izstr\u0101d\u0101ja ImmunoACT IIT Bombej\u0101, un t\u0101 maks\u0101 aptuveni 50 000 ASV dol\u0101ru - aptuveni desmito da\u013cu no sal\u012bdzin\u0101miem Rietumu produktiem. <a href=\"https:\/\/www.dasgelbeblatt.de\/welt\/immunzelltherapie-heilt-ueberraschend-krebs-bei-einem-jugendlichen-zr-94168662.html\" target=\"_blank\" rel=\"noreferrer noopener\">Dzelten\u0101 lapa<\/a><\/p>\n\n\n\n<p><strong>Nor\u0101de<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Atgriezusies\/refrakt\u0101ra B-\u0161\u016bnu ne-Hod\u017ekina limfoma un B-\u0161\u016bnu ALL<\/li>\n<\/ul>\n\n\n\n<p><strong>\u0100rstniec\u012bbas centrs:<\/strong> Tata memori\u0101l\u0101 slimn\u012bca, Mumbai <br><strong>Ra\u017eot\u0101js:<\/strong> <a href=\"https:\/\/www.immunoact.com\" target=\"_blank\" rel=\"noopener\">ImmunoACT<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"TCR-T-ZELLTHERAPIEN_zugelassen\"><\/span>TCR-T \u0161\u016bnu terapijas (at\u013cautas)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Afamitresgene_Autoleucel_Tecelra%C2%AE_%E2%80%93_Adaptimmune_August_2024\"><\/span>Afamitresg\u0113ns Autoleucel (Tecelra\u00ae) - <em>Adaptimmune<\/em> <em>(2024. gada augusts)<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>2024. gada 2. august\u0101 FDA apstiprin\u0101ja Afamitresgene autoleucel (Afami-cel, Tecelra) k\u0101 pirmo TCR T-\u0161\u016bnu terapiju v\u0113\u017ea \u0101rst\u0113\u0161anai un jo \u012bpa\u0161i k\u0101 pirmo \u0123en\u0113tiski in\u017eenierijas T-\u0161\u016bnu prepar\u0101tu, kas paredz\u0113ts stabilu audz\u0113ju \u0101rst\u0113\u0161anai. <a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC12283372\/\" target=\"_blank\" rel=\"noreferrer noopener\">PubMed Central<\/a><\/p>\n\n\n\n<p><strong>M\u0113r\u0137a antig\u0113ns:<\/strong> MAGE-A4 (intracelul\u0101rais v\u0113\u017ea s\u0113klinieku antig\u0113ns), ko rada HLA-A*02:01.<br><strong>Pilnvarots:<\/strong> FDA 2024. gada augusts<\/p>\n\n\n\n<p><strong>Nor\u0101de<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pieaugu\u0161ie ar ne\u0101rst\u0113jamu v\u0113zi vai v\u0113zi ar metast\u0101z\u0113m <strong>Sinovi\u0101l\u0101 sarkoma<\/strong> (m\u012bksto audu sarkoma), iepriek\u0161 \u0101rst\u0113ta ar \u0137\u012bmijterapiju, MAGE-A4 pozit\u012bva un HLA-A*02:01 pozit\u012bva.<\/li>\n<\/ul>\n\n\n\n<p>Galvenaj\u0101 2. f\u0101zes p\u0113t\u012bjum\u0101 SPEARHEAD-1 sinovi\u0101l\u0101s sarkomas pacientu audz\u0113ji rea\u0123\u0113ja uz \u0101rst\u0113\u0161anu vid\u0113ji 11,6 m\u0113ne\u0161us. Da\u017eiem pacientiem audz\u0113ju nevar\u0113ja konstat\u0113t vair\u0101kus gadus. <a href=\"https:\/\/www.clinicaltrialvanguard.com\/news\/t-knife-files-for-phase-1-trial-of-prame-t-cell-therapy\/\" target=\"_blank\" rel=\"noreferrer noopener\">Clinicaltrialvanguard<\/a><\/p>\n\n\n\n<p><strong>Svar\u012bg\u0101kais p\u0113t\u012bjums<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>SPEARHEAD-1 (2. f\u0101ze): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04044858\" target=\"_blank\" rel=\"noopener\">NCT04044858<\/a> | <a href=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(24)00319-2\/fulltext\" target=\"_blank\" rel=\"noopener\">Lancet 2024. gada apr\u012blis<\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>\u0100rstniec\u012bbas centrs (Pioneer):<\/strong> Memorial Sloan Kettering Cancer Centre, \u0145ujorka - <a href=\"https:\/\/www.mskcc.org\/news\/immunotherapy-clinical-trial-shows-promise-for-treating-rare-sarcomas\" target=\"_blank\" rel=\"noopener\">MSK Tecelra Info<\/a><br><strong>FDA produkta lapa:<\/strong> <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/tecelra\" target=\"_blank\" rel=\"noopener\">FDA Tecelra<\/a> <br><strong>NCI raksts:<\/strong> <a href=\"https:\/\/www.cancer.gov\/news-events\/cancer-currents-blog\/2024\/fda-tecelra-synovial-sarcoma-mage-a4\" target=\"_blank\" rel=\"noopener\">cancer.gov TCR terapija<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tebentafusp-tebn_Kimmtrak%C2%AE_%E2%80%93_Immunocore_Januar_2022\"><\/span>Tebentafusp-tebn (Kimmtrak\u00ae) - <em>Immunocore<\/em> <em>(2022. gada janv\u0101ris)<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Tas nav klasisks \u0161\u016bnu produkts (nevis inf\u016bziju veid\u0101 ievad\u012bts T \u0161\u016bnu produkts), bet gan bispecifisks TCR fusion prote\u012bns, ta\u010du meh\u0101niski ietilpst uz TCR balst\u012btas im\u016bnterapijas kategorij\u0101 un bie\u017ei tiek apspriests k\u0101 PRAME-TCER\u00ae tehnolo\u0123ijas priek\u0161tece.<\/p>\n\n\n\n<p><strong>Meh\u0101nisms:<\/strong> No vienas puses, saist\u0101s ar gp100 pept\u012bdu + HLA-A*02:01 uz audz\u0113ja \u0161\u016bn\u0101m, no otras - ar CD3 uz T \u0161\u016bn\u0101m (ImmTAC tehnolo\u0123ija).<br><strong>Pilnvarots:<\/strong> FDA 2022. gada janv\u0101ris \/ EMA 2022. gada febru\u0101ris<\/p>\n\n\n\n<p><strong>Indik\u0101cijas:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>HLA-A*02:01 pozit\u012bvi pieaugu\u0161ie ar neresekt\u0113jamu vai metast\u0101z\u0113tu v\u0113zi <strong>uve\u0101l\u0101 melanoma<\/strong> (acu melanoma) - 1. l\u012bnija<\/li>\n<\/ul>\n\n\n\n<p><strong>\u012apa\u0161\u0101 funkcija:<\/strong> Pirm\u0101s jebkad apstiprin\u0101t\u0101s z\u0101les uve\u0101l\u0101s melanomas \u0101rst\u0113\u0161anai<\/p>\n\n\n\n<p>IMCgp100-202 3. f\u0101zes p\u0113t\u012bjum\u0101 tebentafusp uzr\u0101d\u012bja b\u016btisku izdz\u012bvo\u0161anas ilguma priek\u0161roc\u012bbu sal\u012bdzin\u0101jum\u0101 ar \u0101rsta izv\u0113l\u0113to (pembrolizumabs, ipilimumabs vai dakarbaz\u012bns): OS medi\u0101na 21,7 pret 16,0 m\u0113ne\u0161iem (HR 0,51; p&lt;0,0001). Viena gada OS r\u0101d\u012bt\u0101js bija 73 % pret 59 %. <a href=\"https:\/\/www.kitz-heidelberg.de\/das-kitz\/kitz-programme\/\" target=\"_blank\" rel=\"noreferrer noopener\">Kitz-heidelberg<\/a><\/p>\n\n\n\n<p><strong>Svar\u012bg\u0101kais p\u0113t\u012bjums<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>IMCgp100-202 (3. f\u0101ze): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03070392\" target=\"_blank\" rel=\"noopener\">NCT0307070392<\/a> | <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2103485\" target=\"_blank\" rel=\"noopener\">NEJM 2021<\/a> | <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2304753\" target=\"_blank\" rel=\"noopener\">3 gadu atjaunin\u0101jums NEJM 2023<\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>FDA lapa:<\/strong> <a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-disco-burst-edition-fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma\" target=\"_blank\" rel=\"noopener\">fda.gov Kimmtrak<\/a> <br><strong>Ra\u017eot\u0101js:<\/strong> <a href=\"https:\/\/www.immunocore.com\/pipeline\/kimmtrak\" target=\"_blank\" rel=\"noopener\">immunocore.com\/kimmtrak<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"TIL-THERAPIE_zugelassen\"><\/span>TIL-TERAPIJA (at\u013cauta)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Lifileucel_Amtagvi%C2%AE_%E2%80%93_Iovance_Biotherapeutics_Februar_2024\"><\/span>Lifileucel (Amtagvi\u00ae) - <em>Iovance Biotherapeutics<\/em> <em>(2024. gada febru\u0101r\u012b)<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Lifileucel tika apstiprin\u0101ts 2024. gada 16. febru\u0101r\u012b k\u0101 pirm\u0101 T-\u0161\u016bnu terapija ciet\u0101 audz\u0113ja \u0101rst\u0113\u0161anai un ar\u012b pirm\u0101 TIL terapija v\u0113stur\u0113. <a href=\"https:\/\/investors.immatics.com\/news-releases\/news-release-details\/immatics-initiates-phase-12-clinical-trial-evaluate-prame-tcr\/\" target=\"_blank\" rel=\"noreferrer noopener\">Immatics N.V.<\/a><\/p>\n\n\n\n<p><strong>Meh\u0101nisms:<\/strong> Audz\u0113js tiek \u0137irur\u0123iski iz\u0146emts, audz\u0113ju infiltr\u0113jo\u0161ie limfoc\u012bti (TIL) tiek izol\u0113ti, masveid\u0101 pavairoti un p\u0113c limfodepil\u0101cijas atkal ievad\u012bti. \u0122en\u0113tisko modifik\u0101ciju nav - tiek izmantota TIL dabisk\u0101 audz\u0113ja atpaz\u012b\u0161ana.<\/p>\n\n\n\n<p><strong>Nor\u0101de<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pieaugu\u0161ie ar ne\u0101rst\u0113jamu v\u0113zi vai v\u0113zi ar metast\u0101z\u0113m <strong>Melanoma<\/strong> (\u0101das melanoma) p\u0113c iepriek\u0161\u0113jas anti-PD-1 terapijas un BRAF\/MEK inhibitora (ja ir BRAF mut\u0101cija).<\/li>\n<\/ul>\n\n\n\n<p>Lifileucel 2. f\u0101zes C-144-01 p\u0113t\u012bjuma piecu gadu ilg\u0101 nov\u0113ro\u0161an\u0101 pier\u0101d\u012bja, ka objekt\u012bv\u0101s atbildes reakcijas r\u0101d\u012bt\u0101js bija 31,4 % un atbildes reakcijas vid\u0113jais ilgums - 36,5 m\u0113ne\u0161i - ar notur\u012bgu ilgtermi\u0146a atbildes reakciju vair\u0101k nek\u0101 30 % atbild\u0113t\u0101jiem. <a href=\"https:\/\/dailyreporter.esmo.org\/esmo-immuno-oncology-congress-2025\/news\/next-generation-prame-directed-tcr-t-cell-therapy-shows-early-activity-in-solid-tumours\" target=\"_blank\" rel=\"noreferrer noopener\">Esmo<\/a><\/p>\n\n\n\n<p><strong>Svar\u012bg\u0101kais p\u0113t\u012bjums<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>C-144-01 (2. f\u0101ze, NCT02360579): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT02360579\" target=\"_blank\" rel=\"noopener\">ClinicalTrials<\/a> | <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/40699950\/\" target=\"_blank\" rel=\"noopener\">FDA apstiprin\u0101juma kopsavilkums PubMed<\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>\u0100rstniec\u012bbas centri (ASV atlase):<\/strong> Johns Hopkins, UCLA, MD Anderson, UCSF, Memorial Sloan Kettering, Mayo Clinic<br><strong>NCI raksts:<\/strong> <a href=\"https:\/\/www.cancer.gov\/news-events\/cancer-currents-blog\/2024\/fda-amtagvi-til-therapy-melanoma\" target=\"_blank\" rel=\"noopener\">cancer.gov TIL terapija<\/a><br><strong>Ra\u017eot\u0101js:<\/strong> <a href=\"https:\/\/www.iovance.com\" target=\"_blank\" rel=\"noopener\">iovance.com<\/a><br><strong>FDA produkta lapa:<\/strong> <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/amtagvi\" target=\"_blank\" rel=\"noopener\">FDA Amtagvi<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ubersicht_aller_Immunzelltherapien_weltweit\"><\/span>P\u0101rskats par vis\u0101m im\u016bn\u0161\u016bnu terapij\u0101m vis\u0101 pasaul\u0113<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Produkts<\/th><th>Akt\u012bv\u0101 viela<\/th><th>Tips<\/th><th>M\u0113r\u0137is<\/th><th>Nor\u0101de<\/th><th>Autoriz\u0101cija<\/th><th>Gads<\/th><\/tr><\/thead><tbody><tr><td><strong>Kymriah<\/strong><\/td><td>Tisag\u0113nkleicels<\/td><td>CAR-T<\/td><td>CD19<\/td><td>B-ALL pediatrij\u0101, LBCL, FL<\/td><td>FDA, EMA<\/td><td>2017<\/td><\/tr><tr><td><strong>Yescarta<\/strong><\/td><td>Axicabtagene-cel<\/td><td>CAR-T<\/td><td>CD19<\/td><td>DLBCL, PMBCL, FL, tFL<\/td><td>FDA, EMA<\/td><td>2017<\/td><\/tr><tr><td><strong>Tecartus<\/strong><\/td><td>Brexucabtagene-cel<\/td><td>CAR-T<\/td><td>CD19<\/td><td>MCL, pieaugu\u0161o B-ALL<\/td><td>FDA, EMA<\/td><td>2020<\/td><\/tr><tr><td><strong>Breyanzi<\/strong><\/td><td>Lisocabtagene-cel<\/td><td>CAR-T<\/td><td>CD19<\/td><td>LBCL, CLL\/SLL, FL<\/td><td>FDA, EMA<\/td><td>2021<\/td><\/tr><tr><td><strong>Abecma<\/strong><\/td><td>Idecabtagene-cel<\/td><td>CAR-T<\/td><td>BCMA<\/td><td>Mult. Mieloma \u22654 rindas<\/td><td>FDA, EMA<\/td><td>2021<\/td><\/tr><tr><td><strong>Carvykti<\/strong><\/td><td>Ciltacabtagene-cel<\/td><td>CAR-T<\/td><td>BCMA<\/td><td>Mult. Mieloma \u22651 l\u012bnija<\/td><td>FDA, EMA, NMPA<\/td><td>2022<\/td><\/tr><tr><td><strong>Kimmtrak<\/strong><\/td><td>Tebentafusp-tebn<\/td><td>TCR-Bispecifiskais<\/td><td>gp100+HLA<\/td><td>Uve\u0101l\u0101 melanoma<\/td><td>FDA, EMA<\/td><td>2022<\/td><\/tr><tr><td><strong>NexCAR19<\/strong><\/td><td>Actalycabtagene-cel<\/td><td>CAR-T<\/td><td>CD19<\/td><td>B-ALL, NHL<\/td><td>CDSCO (Indija)<\/td><td>2023<\/td><\/tr><tr><td><strong>Amtagvi<\/strong><\/td><td>Lifileucel<\/td><td>TIL<\/td><td>Poliklon\u0101ls<\/td><td>Melanoma (sol\u012bds audz\u0113js)<\/td><td>FDA<\/td><td>2024<\/td><\/tr><tr><td><strong>Tecelra<\/strong><\/td><td>Afamitresgene-cel<\/td><td>TCR-T<\/td><td>MAGE-A4+HLA<\/td><td>Sinovi\u0101l\u0101 sarkoma<\/td><td>FDA<\/td><td>2024<\/td><\/tr><tr><td><strong>Aucatzyl<\/strong><\/td><td>Obecabtagene-cel<\/td><td>CAR-T<\/td><td>CD19<\/td><td>Pieaugu\u0161o B-ALL<\/td><td>FDA<\/td><td>2024<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Nebenwirkungen_%E2%80%93_Was_alle_Therapien_verbindet\"><\/span>Blakuspar\u0101d\u012bbas - kas kop\u012bgs vis\u0101m terapij\u0101m<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Svar\u012bg\u0101kie kop\u0113jie riski:<\/p>\n\n\n\n<p><strong>Citok\u012bnu v\u0113tra (CRS)<\/strong><br>Bie\u017ei sastopama ar CAR-T un TCR-T; reti ar TIL.<br>\u0100rst\u0113\u0161ana ar tocilizumabu.<br>Kop\u0161 2024. gada uz visiem CAR-T mar\u0137\u0113jumiem: br\u012bdin\u0101jums ielikum\u0101 par sekund\u0101riem T \u0161\u016bnu \u013caundab\u012bgiem audz\u0113jiem (\u013coti reti, ~ 3,6 % gadu laik\u0101).<\/p>\n\n\n\n<p><strong>ICANS (neirotoksicit\u0101te)<\/strong><br>Im\u016bn\u0161\u016bnu izrais\u012bts neirotoksicit\u0101tes sindroms; paz\u012bstams CAR-T, ret\u0101k sastopams TIL.<\/p>\n\n\n\n<p><strong>Citop\u0113nijas<\/strong><br>Nepiecie\u0161am\u0101 limfodepil\u0101cija (\u0137\u012bmijterapija pirms inf\u016bzijas) vienm\u0113r izraisa \u012bslaic\u012bgas asins ainas izmai\u0146as.<\/p>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Wo_werden_diese_Therapien_in_Deutschland_angeboten\"><\/span>Kur V\u0101cij\u0101 tiek pied\u0101v\u0101tas \u0161\u012bs terapijas?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Visi FDA\/EMA apstiprin\u0101tie CAR-T produkti tiek ra\u017eoti <strong>specializ\u0113tie transplant\u0101cijas centri<\/strong> ko sertific\u0113ju\u0161i ra\u017eot\u0101ji un akredit\u0113jusi DKMS\/EBMT:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Hamburgas-Eppendorfas Universit\u0101tes Medic\u012bnas centrs (UKE):<\/strong> <a href=\"https:\/\/www.uke.de\" target=\"_blank\" rel=\"noopener\">uke.de<\/a><\/li>\n\n\n\n<li><strong>Charit\u00e9 - Universit\u00e4tsmedizin Berlin:<\/strong> <a href=\"https:\/\/www.charite.de\" target=\"_blank\" rel=\"noopener\">charite.de<\/a><\/li>\n\n\n\n<li><strong>LMU Minhenes kl\u012bniskais centrs:<\/strong> <a href=\"https:\/\/www.lmu-klinikum.de\" target=\"_blank\" rel=\"noopener\">lmu-klinikum.de<\/a><\/li>\n\n\n\n<li><strong>Heidelbergas Universit\u0101tes slimn\u012bca \/ KiTZ:<\/strong> <a href=\"https:\/\/www.kitz-heidelberg.de\" target=\"_blank\" rel=\"noopener\">kitz-heidelberg.de<\/a> <em>(ar\u012b: PRAME p\u0113t\u012bjums)<\/em><\/li>\n\n\n\n<li><strong>Frankfurtes Universit\u0101tes slimn\u012bca:<\/strong> <a href=\"https:\/\/www.uniklinik-frankfurt.de\" target=\"_blank\" rel=\"noopener\">uniklinik-frankfurt.de<\/a><\/li>\n\n\n\n<li><strong>Freiburgas Universit\u0101tes Medic\u012bnas centrs:<\/strong> <a href=\"https:\/\/www.uniklinik-freiburg.de\" target=\"_blank\" rel=\"noopener\">uniklinik-freiburg.de<\/a><\/li>\n\n\n\n<li><strong>Diseldorfas Universit\u0101tes slimn\u012bca \/ Esene:<\/strong> specializ\u0113jas MCL\/DLBCL-CAR-T jom\u0101.<\/li>\n<\/ul>\n\n\n\n<p><strong>Pilns sertific\u0113to CAR-T centru saraksts:<\/strong> <a href=\"https:\/\/www.ebmt.org\/registry\/center-search\" target=\"_blank\" rel=\"noopener\">EBMT centra mekl\u0113\u0161ana<\/a><\/p>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ausblick_Was_kommt_als_nachstes\"><\/span>Perspekt\u012bvas: Kas t\u0101l\u0101k?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>N\u0101kamais apstiprin\u0101to im\u016bn\u0161\u016bnu terapiju vilnis gaid\u0101ms 2026.-2028. gad\u0101:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>IMA203 \/ Anzu-cel (PRAME-TCR):<\/strong> Tiek veikts SUPRAME 3. f\u0101zes p\u0113t\u012bjums - <em>Iesp\u0113jam\u0101 at\u013cauja melanomas \u0101rst\u0113\u0161anai 2027\/2028<\/em><\/li>\n\n\n\n<li><strong>Lifileucel + pembrolizumabs (3. f\u0101ze):<\/strong> Pirm\u0101s l\u012bnijas p\u0113t\u012bjums NCT05727904 - - <em>Iesp\u0113jamais melanomas pirm\u0101s l\u012bnijas apstiprin\u0101jums<\/em><\/li>\n\n\n\n<li><strong>Brenetafusp (PRISM-MEL-301):<\/strong> 3. f\u0101zes p\u0113t\u012bjums PRAME\u00d7CD3-Bispecifiskais - <em>Iesp\u0113jam\u0101 at\u013cauja 2027<\/em><\/li>\n\n\n\n<li><strong>CAR-T autoim\u016bno slim\u012bbu (SLE, MS) \u0101rst\u0113\u0161anai:<\/strong> 2. f\u0101zes p\u0113t\u012bjumi; iesp\u0113jams, pirmais neonkolo\u0123iskais CAR-T produkts.<\/li>\n\n\n\n<li><strong>KiTZ Heidelbergas pediatrijas PRAME p\u0113t\u012bjums:<\/strong> pl\u0101nots 2026. gad\u0101 - pasaul\u0113 pirmais p\u0113t\u012bjums b\u0113rniem<\/li>\n<\/ul>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h1 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"GKV-Erstattung_von_Immunzelltherapien_in_Deutschland\"><\/span>Im\u016bn\u0161\u016bnu terapijas SHI kompens\u0101cija V\u0101cij\u0101<span class=\"ez-toc-section-end\"><\/span><\/h1>\n\n\n\n<p>Statuss 02.2026<\/p>\n\n\n\n<p>Situ\u0101cija ir sare\u017e\u0123\u012bta un \u013coti at\u0161\u0137iras atkar\u012bb\u0101 no terapijas veida, produkta un vesel\u012bbas apdro\u0161in\u0101\u0161anas sabiedr\u012bbas. Nav vienotas likmes, autom\u0101tiskas kompens\u0101cijas, k\u0101 tas ir tradicion\u0101lo z\u0101\u013cu gad\u012bjum\u0101. T\u0101 viet\u0101 past\u0101v daudzpak\u0101pju sist\u0113ma ar iev\u0113rojamu birokr\u0101tiju, ko \u0101rsti un kl\u012bnikas atkl\u0101ti kritiz\u0113 k\u0101 nefunkcion\u0101lu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CAR-T-Zelltherapien\"><\/span>CAR-T \u0161\u016bnu terapijas<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Parasti atmaks\u0101jama, bet sare\u017e\u0123\u012bta<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"AMNOG_NUB-Verfahren\"><\/span>AMNOG un NUB proced\u016bra<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>CAR-T prepar\u0101ti ir <strong>Uzlabotas terapijas z\u0101les (ATMP)<\/strong> un uz tiem attiecas V\u0101cijas <strong>AMNOG proced\u016bra<\/strong> (Farm\u0101cijas tirgus reorganiz\u0101cijas likums). Tas paredz<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Fruhe_Nutzenbewertung_durch_den_G-BA\"><\/span>G-BA veikts agr\u012bns ieguvumu nov\u0113rt\u0113jums<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Kop\u0161 2011. gada 1. janv\u0101ra G-BA likum\u0101 noteiktais uzdevums ir veikt ieguvumu nov\u0113rt\u0113jumu vis\u0101m jaunat\u013cautaj\u0101m z\u0101l\u0113m ar jaun\u0101m akt\u012bvaj\u0101m viel\u0101m uzreiz p\u0113c to lai\u0161anas tirg\u016b.<br>Tiek p\u0101rbaud\u012bts, vai jaun\u0101s z\u0101les ir lab\u0101kas par iepriek\u0161\u0113jo standarta terapiju - t. s. <strong>atbilsto\u0161a sal\u012bdzino\u0161\u0101 terapija<\/strong> - sniedz priek\u0161roc\u012bbas.<\/p>\n\n\n\n<p><strong>Juridiskais pamats:<\/strong> <a href=\"https:\/\/www.gesetze-im-internet.de\/sgb_5\/__35a.html\" target=\"_blank\" rel=\"noopener\">\u00a7 35.a SGB V pants - Z\u0101\u013cu ieguvumu nov\u0113rt\u0113\u0161ana (juridiskais formul\u0113jums)<\/a><\/p>\n\n\n\n<p><strong>Proced\u016bras apraksts G-BA:<\/strong> <a href=\"https:\/\/www.g-ba.de\/themen\/arzneimittel\/arzneimittel-richtlinie-anlagen\/nutzenbewertung-35a\/\" target=\"_blank\" rel=\"noopener\">g-ba.de - AMNOG pabalsta nov\u0113rt\u0113jums saska\u0146\u0101 ar SGB V 35.a pantu<\/a><\/p>\n\n\n\n<p>\u0160\u012b ieguvumu nov\u0113rt\u0113juma rezult\u0101ts ir s\u0101kumpunkts sarun\u0101m par cenu starp GKV-Spitzenverband un z\u0101\u013cu ra\u017eot\u0101ju.<br>Iesp\u0113jam\u0101s pievienot\u0101 ieguvuma nov\u0113rt\u0113\u0161anas kategorijas ir defin\u0113tas V\u0101cijas R\u012bkojum\u0101 par z\u0101\u013cu pabalstu nov\u0113rt\u0113\u0161anu un G-BA proced\u016bras kodeksa 5. noda\u013c\u0101.<\/p>\n\n\n\n<p>\u010cetras papildu pabalstu kategorijas ir \u0161\u0101das:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Noz\u012bm\u012bgs<\/strong> Papildu priek\u0161roc\u012bbas<\/li>\n\n\n\n<li><strong>Iev\u0113rojams<\/strong> Papildu priek\u0161roc\u012bbas<\/li>\n\n\n\n<li><strong>Apak\u0161\u0113j\u0101<\/strong> Papildu priek\u0161roc\u012bbas<\/li>\n\n\n\n<li><strong>Nav<\/strong> Pier\u0101d\u012bts papildu ieguvums<\/li>\n<\/ul>\n\n\n\n<p><strong>\u010cetras kategorijas s\u0101kotn\u0113j\u0101 formul\u0113jum\u0101:<\/strong> <a href=\"https:\/\/www.g-ba.de\/themen\/arzneimittel\/arzneimittel-richtlinie-anlagen\/nutzenbewertung-35a\/zusatznutzen\/\" target=\"_blank\" rel=\"noopener\">g-ba.de - Pievienot\u0101s v\u0113rt\u012bbas kategorijas<\/a><\/p>\n\n\n\n<p><strong>Kategoriju juridiskais pamats:<\/strong> <a href=\"https:\/\/www.gesetze-im-internet.de\/am-nutzenv\/BJNR232400010.html\" target=\"_blank\" rel=\"noopener\">AM-NutzenV 5. panta 7. punkts - R\u012bkojums par z\u0101\u013cu pabalstu nov\u0113rt\u0113\u0161anu (juridiskais formul\u0113jums)<\/a><\/p>\n\n\n\n<p><strong>Konkr\u0113ts piem\u0113rs: G-BA proced\u016bra Yescarta (CAR-T):<\/strong> <a href=\"https:\/\/www.g-ba.de\/bewertungsverfahren\/nutzenbewertung\/406\/\" target=\"_blank\" rel=\"noopener\">g-ba.de - Labuma nov\u0113rt\u0113\u0161anas proced\u016bra Axicabtagene-Ciloleucel<\/a><\/p>\n\n\n\n<p><strong>Visas notieko\u0161\u0101s un pabeigt\u0101s G-BA nov\u0113rt\u0113\u0161anas proced\u016bras:<\/strong> <a href=\"https:\/\/www.g-ba.de\/bewertungsverfahren\/nutzenbewertung\/\" target=\"_blank\" rel=\"noopener\">g-ba.de - Nov\u0113rt\u0113\u0161anas proced\u016bras p\u0101rskats<\/a><\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Preisverhandlung_nach_%C2%A7_130b_SGB_V\"><\/span>Sarunas par cenu saska\u0146\u0101 ar SGB 130.b pantu V<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Pamatojoties uz G-BA l\u0113mumu par jauno z\u0101\u013cu papildu ieguvumu, GKV-Spitzenverband un farm\u0101cijas uz\u0146\u0113mums parasti se\u0161u m\u0113ne\u0161u laik\u0101 \u010detr\u0101s sarunu san\u0101ksm\u0113s vienojas par t\u0101 saukto kompens\u0101cijas summu. No sept\u012bt\u0101 m\u0113ne\u0161a p\u0113c z\u0101\u013cu lai\u0161anas tirg\u016b t\u0101 tiek piem\u0113rota k\u0101 jaun\u0101 valsts m\u0113roga z\u0101\u013cu izsnieg\u0161anas cena - gan oblig\u0101t\u0101s vesel\u012bbas apdro\u0161in\u0101\u0161anas, gan priv\u0101t\u0101s apdro\u0161in\u0101\u0161anas, gan pa\u0161maks\u0101t\u0101jiem.<\/p>\n\n\n\n<p><strong>Juridiskais pamats:<\/strong> <a href=\"https:\/\/www.gesetze-im-internet.de\/sgb_5\/__130b.html\" target=\"_blank\" rel=\"noopener\">\u00a7 130.b SGB V sada\u013ca - Vieno\u0161an\u0101s par atl\u012bdz\u012bbas summ\u0101m (likuma redakcija)<\/a><\/p>\n\n\n\n<p><strong>Proced\u016bras apraksts GKV-Spitzenverband:<\/strong> <a href=\"https:\/\/www.gkv-spitzenverband.de\/krankenversicherung\/arzneimittel\/verhandlungen_nach_amnog\/rabatt_verhandlungen_nach_amnog.jsp\" target=\"_blank\" rel=\"noopener\">gkv-spitzenverband.de - AMNOG sarunas saska\u0146\u0101 ar SGB V 130.b pantu<\/a><\/p>\n\n\n\n<p><strong>P\u0101rskats par vis\u0101m p\u0101rrun\u0101taj\u0101m kompens\u0101ciju summ\u0101m (tostarp CAR-T produktiem):<\/strong> <a href=\"https:\/\/www.gkv-spitzenverband.de\/krankenversicherung\/arzneimittel\/verhandlungen_nach_amnog\/ebv_130b\/ebv_nach_130b.jsp\" target=\"_blank\" rel=\"noopener\">gkv-spitzenverband.de - L\u012bgumi par atmaks\u0101jam\u0101m summ\u0101m<\/a><\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"NUB-Verfahren_fur_Krankenhauser\"><\/span>NUB proced\u016bra slimn\u012bc\u0101m<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>T\u0101 k\u0101 CAR-T terapijas tiek lietotas stacion\u0101r\u0101, ar\u012b uz kl\u012bnik\u0101m attiecas \u0161\u0101das pras\u012bbas. <strong>NUB proced\u016bra<\/strong> (Jaunas p\u0101rbaudes un apstr\u0101des metodes saska\u0146\u0101 ar KHEntgG 6. panta 2. punktu).<\/p>\n\n\n\n<p>NUB proced\u016bra nov\u0113r\u0161 t\u0101 saukto \u201einov\u0101ciju plaisu\u201c, kas parasti ir tr\u012bs gadu periods, kam\u0113r jauna terapija tiek piln\u012bb\u0101 iek\u013cauta G-DRG vienot\u0101s likmes sist\u0113m\u0101.<br>\u0160aj\u0101 period\u0101 slimn\u012bcas var vienoties ar slimokas\u0113m par slimn\u012bc\u0101m noteikt\u0101m NUB maks\u0101m, ja Slimn\u012bcu atalgojuma sist\u0113mas instit\u016bts (InEK) p\u0113c p\u0101rbaudes pie\u0161\u0137ir 1. statusu.<\/p>\n\n\n\n<p>Katru gadu l\u012bdz 31. oktobrim slimn\u012bc\u0101m j\u0101iesniedz NUB pieteikumi InEK. InEK public\u0113 p\u0101rbaudes rezult\u0101tus l\u012bdz n\u0101kam\u0101 gada janv\u0101ra beig\u0101m.<\/p>\n\n\n\n<p>ATMP (uzlabotas terapijas z\u0101l\u0113m), kas ietver visas CAR-T un TCR-T z\u0101les, piem\u0113ro pagarin\u0101to pieteikumu iesnieg\u0161anas termi\u0146u - katra gada 30. apr\u012blis, ja vien pieteikums nav iesniegts l\u012bdz 31. oktobrim.<\/p>\n\n\n\n<p><strong>NUB proced\u016bras amatpersona (InEK):<\/strong> <a href=\"https:\/\/www.g-drg.de\/neue-untersuchungs-und-behandlungsmethoden-nub\/drg\" target=\"_blank\" rel=\"noopener\">g-drg.de - NUB proced\u016bra attiec\u012bb\u0101 uz ATMP<\/a><\/p>\n\n\n\n<p><strong>NUB proced\u016bra (GKV-Spitzenverband):<\/strong> <a href=\"https:\/\/www.gkv-spitzenverband.de\/krankenversicherung\/krankenhaeuser\/drg_system\/neue_untersuchungs_und_behandlungsmethoden_nub\/neue_untersuchungs_und_behandlungsmethoden_nub.jsp\" target=\"_blank\" rel=\"noopener\">gkv-spitzenverband.de - NUB slimn\u012bc\u0101s<\/a><\/p>\n\n\n\n<p><strong>Detaliz\u0113ts procesa skaidrojums ar ATMP \u012bpa\u0161ajiem noteikumiem:<\/strong> <a href=\"https:\/\/reimbursement.institute\/nub-antrag\/\" target=\"_blank\" rel=\"noopener\">atmaks\u0101\u0161ana.instit\u016bts - NUB piepras\u012bjuma proced\u016bra<\/a><\/p>\n\n\n\n<p><strong>AOK p\u0101rskats NUB 2025 (ar pa\u0161reiz\u0113j\u0101 st\u0101vok\u013ca r\u0101d\u012bt\u0101jiem):<\/strong> <a href=\"https:\/\/www.aok.de\/gp\/krankenhaus\/verguetung-drg\/nub\" target=\"_blank\" rel=\"noopener\">aok.de\/gp - NUB somatik\u0101<\/a><\/p>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Die_Realitat_Einzelfallantrage_und_Burokratie\"><\/span>Realit\u0101te: individu\u0101li pieteikumi un birokr\u0101tija<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Neraugoties uz sarunu ce\u013c\u0101 noteiktaj\u0101m atl\u012bdz\u012bbas summ\u0101m, prakse kl\u012bnik\u0101m un pacientiem ir iev\u0113rojami sare\u017e\u0123\u012bt\u0101ka, nek\u0101 tas izriet no ofici\u0101lajiem noteikumiem.<\/p>\n\n\n\n<p>L\u012bdz \u0161im centriem parasti bija j\u0101iesniedz individu\u0101ls pieteikums par izmaksu seg\u0161anu no oblig\u0101t\u0101s vesel\u012bbas apdro\u0161in\u0101\u0161anas.<br>Nav standartiz\u0113ta, autom\u0101tiska izmaksu seguma cilv\u0113kiem ar oblig\u0101to vesel\u012bbas apdro\u0161in\u0101\u0161anu.<\/p>\n\n\n\n<p><strong>Avots:<\/strong> <a href=\"https:\/\/www.krebsinformationsdienst.de\/fachkreise\/nachrichten\/detail\/update-car-t-zell-therapie\" target=\"_blank\" rel=\"noopener\">DKFZ V\u0113\u017ea inform\u0101cijas dienests - Atjaunin\u0101t CAR-T: vienota pieteik\u0161an\u0101s proced\u016bra un atlai\u017eu l\u012bgumi<\/a><\/p>\n\n\n\n<p>T\u0101 k\u0101 CAR-T prepar\u0101ts maks\u0101 vair\u0101kus simtus t\u016bksto\u0161u eiro, kl\u012bnik\u0101m pirms terapijas uzs\u0101k\u0161anas ir j\u0101sa\u0146em izmaksu segums. LMU Klinikum M\u00fcnchen vec\u0101kais \u0101rsts Dr. Veits Bukleins (Veit B\u00fccklein) st\u0101sta par ieguld\u012bto darbu: \u201eMums ir j\u0101aizpilda kontrolsaraksts un j\u0101sast\u0101da daudzi, daudzi dokumenti, s\u0101kot no A - \u0101rsta v\u0113stule un beidzot ar Z - visu rezult\u0101tu apkopojums\u201c. Ofici\u0101l\u0101 proced\u016bra tiek saukta par \u201eindividu\u0101lo izmaksu atl\u012bdzin\u0101\u0161anas pieteikuma proced\u016bru\u201c.<\/p>\n\n\n\n<p><strong>Avots:<\/strong> <a href=\"https:\/\/pharma-fakten.de\/news\/car-t-zelltherapie-zukunftsversprechen-versus-burokratiemonster\/\" target=\"_blank\" rel=\"noopener\">Farm\u0101cijas fakti - CAR-T: n\u0101kotnes sol\u012bjums pret birokr\u0101tijas monstru (LMU Klinikum M\u00fcnchen, 2024. gada septembris)<\/a><\/p>\n\n\n\n<p>Prof. Dr. Marion Subklewe, LMU Klinikum M\u00fcnchen CAR-T programmas vad\u012bt\u0101ja, rezum\u0113 kritiku: \u201eM\u0113s str\u0101d\u0101jam ar apstiprin\u0101tiem produktiem. Es nesaprotu, k\u0101p\u0113c katru reizi ir j\u0101iesniedz individu\u0101ls pieteikums par apstiprin\u0101tu produktu.\u201c Kompens\u0101cijas procesi pa\u0161laik ir \u201einstruments, kas apgr\u016btina progresu\u201c.<\/p>\n\n\n\n<p><strong>Avots:<\/strong> <a href=\"https:\/\/pharma-fakten.de\/news\/car-t-zelltherapien-optimale-versorgung-sieht-anders-aus\/\" target=\"_blank\" rel=\"noopener\">Farm\u0101cijas fakti - CAR-T: optim\u0101la apr\u016bpe izskat\u0101s cit\u0101di (2025. gada apr\u012blis)<\/a><\/p>\n\n\n\n<p>Prof. Dr. Michael Hallek, \u0136elnes Universit\u0101tes slimn\u012bcas I Iek\u0161\u0137\u012bgo slim\u012bbu kl\u012bnikas direktors, ierosina, ka risin\u0101jums b\u016btu sistem\u0101tiski pie\u0161\u0137irt CAR-T \u0161\u016bnu terapijas specializ\u0113tiem centriem, kas var dokument\u0113t savu darbu un pier\u0101d\u012bt pier\u0101d\u012bt pier\u0101d\u012btus pan\u0101kumus, un tad dot \u0161iem centriem br\u012bvu roku l\u0113mumu pie\u0146em\u0161an\u0101 par \u0101rst\u0113\u0161anu: \u201eTad var aizmirst par p\u0101rskat\u012b\u0161anas procesu, jo kam citam, ja ne mums, ir j\u0101nov\u0113rt\u0113, vai \u0101rst\u0113\u0161ana ir pareiza vai nav pareiza?\u201c<\/p>\n\n\n\n<p><strong>Avots:<\/strong> <a href=\"https:\/\/pharma-fakten.de\/news\/car-t-zelltherapie-woran-es-noch-fehlt\/\" target=\"_blank\" rel=\"noopener\">Farm\u0101cijas fakti - CAR-T: kas v\u0113l tr\u016bkst (\u0136elnes Universit\u0101tes slimn\u012bcas pas\u0101kums, 2025. gada j\u016blijs)<\/a><\/p>\n\n\n\n<p>No universit\u0101\u0161u slimn\u012bcu viedok\u013ca galven\u0101 struktur\u0101l\u0101 probl\u0113ma ir t\u0101, ka likumdev\u0113js nav nov\u0113rsis laika spr\u012bdi starp z\u0101\u013cu apstiprin\u0101\u0161anu un slimn\u012bc\u0101m garant\u0113taj\u0101m ties\u012bb\u0101m sa\u0146emt kompens\u0101ciju. Jaunu \u0161\u016bnu un g\u0113nu terapiju gad\u012bjum\u0101 slimn\u012bcu finansi\u0101lais risks ir p\u0101r\u0101k liels, lai t\u0101s var\u0113tu veikt avansa maks\u0101jumus.<\/p>\n\n\n\n<p><strong>Avots:<\/strong> <a href=\"https:\/\/www.uniklinika.de\/gesundheitspolitischethemen\/car-t-zelltherapie\/\" target=\"_blank\" rel=\"noopener\">Uniklinika.de - CAR-T \u0161\u016bnu terapija: piepras\u012bjums p\u0113c kompens\u0101cijas dro\u0161\u012bbas<\/a><\/p>\n\n\n\n<p>\u0160o kav\u0113jumu medic\u012bnisk\u0101s sekas ir izm\u0113r\u0101mas: viena m\u0113ne\u0161a gaid\u012b\u0161ana uz CAR-T \u0161\u016bnu terapiju var palielin\u0101t relat\u012bvo mirst\u012bbu par 6,2 procentiem. Jebkur\u0161 kav\u0113jums CAR-T pieejam\u012bbas nodro\u0161in\u0101\u0161an\u0101 var tie\u0161i ietekm\u0113t \u0101rst\u0113\u0161anas pan\u0101kumus.<\/p>\n\n\n\n<p><strong>Avots:<\/strong> <a href=\"https:\/\/pharma-fakten.de\/news\/car-t-zelltherapien-optimale-versorgung-sieht-anders-aus\/\" target=\"_blank\" rel=\"noopener\">Pharma-Fakten \/ IQVIA Institute - CAR-T: optim\u0101la apr\u016bpe izskat\u0101s cit\u0101di (ar atsauci uz IQVIA p\u0113t\u012bjumu)<\/a><\/p>\n\n\n\n<p>Turkl\u0101t past\u0101v v\u0113l viena struktur\u0101la probl\u0113ma: vair\u0101k nek\u0101 160 slimn\u012bcas ir iesniegu\u0161as NUB pieteikumus, lai var\u0113tu pied\u0101v\u0101t CAR-T terapiju, ta\u010du s\u0101kotn\u0113ji t\u0101m tika pie\u0161\u0137irts tikai 4. NUB statuss, kas noz\u012bm\u0113, ka SHI nav pien\u0101kuma segt izmaksas k\u0101 da\u013cu no NUB l\u012bgumiem.<\/p>\n\n\n\n<p><strong>Avots:<\/strong> <a href=\"https:\/\/www.vdek.com\/magazin\/ausgaben\/2018-1112\/politik_car_t_zelltherapie.html\" target=\"_blank\" rel=\"noopener\">VDEK - Revol\u016bcija onkolo\u0123ij\u0101: NUB statuss un atl\u012bdzin\u0101\u0161anas jaut\u0101jumi saist\u012bb\u0101 ar CAR-T<\/a><\/p>\n\n\n\n<p>Prof. Subklevs apraksta \u012bpa\u0161i absurdu piem\u0113ru no slimn\u012bcas ikdienas: \u201eMan ir j\u0101pasaka, ka gastroenterologam j\u0101b\u016bt blakus 24 stundas diennakt\u012b, lai gan p\u0113d\u0113jo piecu gadu laik\u0101 man nekad nav bijis vajadz\u012bgs gastroenterologs.\u201c<br>Lai gan atsevi\u0161\u0137as kvalit\u0101tes un struktur\u0101l\u0101s pras\u012bbas ir pamatotas, t\u0101s nedr\u012bkst iziet \u0101rpus kontroles, k\u0101 tas ir pa\u0161laik.<\/p>\n\n\n\n<p><strong>Avots:<\/strong> <a href=\"https:\/\/pharma-fakten.de\/news\/car-t-zelltherapie-zukunftsversprechen-versus-burokratiemonster\/\" target=\"_blank\" rel=\"noopener\">Farm\u0101cijas fakti - CAR-T: n\u0101kotnes sol\u012bjums pret birokr\u0101tijas monstru<\/a><\/p>\n\n\n\n<p><strong>P\u0101rskats par kvalific\u0113tiem CAR-T centriem V\u0101cij\u0101<\/strong> (pacientiem un nos\u016bt\u012bt\u0101jiem \u0101rstiem):<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.novartis.com\/de-de\/uebersicht-behandelnder-car-t-zentren-deutschland\" target=\"_blank\" rel=\"noopener\">Novartis - CAR-T \u0101rst\u0113\u0161anas centru p\u0101rskats V\u0101cij\u0101 (Kymriah)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.lmu-klinikum.de\/aktuelles\/pressemitteilungen\/funf-jahre-car-t-zelltherapie-am-lmu-klinikum-nbsp\/c52167393f8351f2\" target=\"_blank\" rel=\"noopener\">LMU Klinikum M\u00fcnchen - CAR-T pieci gadi: programma un kontakti<\/a> <\/li>\n\n\n\n<li><a href=\"https:\/\/www.dkfz.de\/de\/presse\/pressemitteilungen\/2020\/dkfz-pm-20-40-CAR-T-Zell-Therapien-erhebliche-Kostenersparnis-moeglich.php\" target=\"_blank\" rel=\"noopener\">DKFZ - CAR T-\u0161\u016bnu terapija: izmaksu ietaup\u012bjums, izmantojot iek\u0161\u0113jo ra\u017eo\u0161anu<\/a><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Das_%E2%80%9EPay-for-Outcome%E2%80%9C-Modell\"><\/span>\u201eMaks\u0101juma par rezult\u0101tu\u201c modelis<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p> (atl\u012bdz\u012bba, kas atkar\u012bga no darba rezult\u0101tiem)<\/p>\n\n\n\n<p>K\u0101 inovat\u012bvu pagaidu risin\u0101jumu individu\u0101lie vesel\u012bbas apdro\u0161in\u0101\u0161anas fondi ir vienoju\u0161ies par t.s. <strong>L\u012bgumi par samaksu par sniegumu<\/strong> sl\u0113gts:<\/p>\n\n\n\n<p>Novartis un GWQ ServicePlus ir nosl\u0113gu\u0161i uz rezult\u0101tiem balst\u012btu Kymriah kompens\u0101cijas modeli, kas ir pirmais \u0161\u0101da veida l\u012bgums V\u0101cij\u0101:<br>Novartis kompens\u0113s da\u013cu z\u0101\u013cu izmaksu, ja pacients noteikt\u0101 laika period\u0101 p\u0113c \u0101rst\u0113\u0161anas nomirs no asins v\u0113\u017ea. <br>Izn\u0101kuma parametrs ir \u0101rst\u0113t\u0101 pacienta izdz\u012bvo\u0161ana.<\/p>\n\n\n\n<p>\u0160is modelis ir rad\u012bjis precedentu: Techniker Krankenkasse un citi aizvietojo\u0161ie vesel\u012bbas apdro\u0161in\u0101\u0161anas fondi ir sekoju\u0161i \u0161im piem\u0113ram, nosl\u0113dzot l\u012bdz\u012bgus l\u012bgumus.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Welche_CAR-T-Produkte_sind_in_Deutschland_erstattungsfahig\"><\/span>Kuri CAR-T produkti ir kompens\u0113jami V\u0101cij\u0101?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Produkts<\/th><th>Nor\u0101de<\/th><th>GKV statuss<\/th><\/tr><\/thead><tbody><tr><td><strong>Kymriah<\/strong> (Tisag\u0113nsleikols)<\/td><td>B-ALL pediatrij\u0101, DLBCL, FL<\/td><td>\u2705 Atmaksas summa, par kuru pan\u0101kta vieno\u0161an\u0101s (no 2019. gada septembra)<\/td><\/tr><tr><td><strong>Yescarta<\/strong> (Axicabtagene-cel)<\/td><td>DLBCL, PMBCL, FL, tFL<\/td><td>\u2705 Atmaksas summa, par kuru pan\u0101kta vieno\u0161an\u0101s<\/td><\/tr><tr><td><strong>Tecartus<\/strong> (Brexucabtagene-cel)<\/td><td>MCL, pieaugu\u0161o B-ALL<\/td><td>EMA apstiprin\u0101ta; NUB proced\u016bra notiek\/ pabeigta<\/td><\/tr><tr><td><strong>Breyanzi<\/strong> (Lisocabtagene-cel)<\/td><td>DLBCL, CLL, FL<\/td><td>EMA apstiprin\u0101ta; NUB proced\u016bra<\/td><\/tr><tr><td><strong>Abecma<\/strong> (Idecabtagene-cel)<\/td><td>Multipl\u0101 mieloma<\/td><td>EMA apstiprin\u0101ta; NUB proced\u016bra<\/td><\/tr><tr><td><strong>Carvykti<\/strong> (Ciltacabtagene-cel)<\/td><td>Multipl\u0101 mieloma<\/td><td>EMA apstiprin\u0101ta; NUB proced\u016bra<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Praktisks priek\u0161noteikums jebkur\u0101 gad\u012bjum\u0101<\/strong><br>\u0100rstniec\u012bbas centram<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>atbilst G-BA ATMP kvalit\u0101tes nodro\u0161in\u0101\u0161anas vadl\u012bnij\u0101m.<\/li>\n\n\n\n<li>FACT\/JACIE akredit\u0101cija<\/li>\n\n\n\n<li>un sa\u0146emt CAR-T centra sertifik\u0101tu.<\/li>\n<\/ul>\n\n\n\n<p>Tikai tad var vienoties par NUB maks\u0101m un izrakst\u012bt r\u0113\u0137inu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Kimmtrak_Tebentafusp_%E2%80%93_Sonderfall\"><\/span>Kimmtrak (Tebentafusp) - \u012bpa\u0161s gad\u012bjums<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Kimmtrak nav \u0161\u016bnu produkts, bet gan <strong>Biofarmaceitiskie produkti<\/strong> un uz to attiecas parast\u0101 AMNOG proced\u016bra t\u0101pat k\u0101 uz cit\u0101m v\u0113\u017ea z\u0101l\u0113m. Tas tiek lietots ambulatori, un parasti ir kompens\u0113jams, izmantojot parastos onkolo\u0123iskos nor\u0113\u0137inu veidus, bet tikai apstiprin\u0101t\u0101s indik\u0101cijas gad\u012bjum\u0101 (<strong>HLA-A*02:01 pozit\u012bva uve\u0101l\u0101 melanoma<\/strong>, pirm\u0101 rinda).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"TIL-Therapie_Lifileucel_Amtagvi_%E2%80%93_In_Deutschland_derzeit_NICHT_erstattungsfahig\"><\/span>TIL terapija (Lifileucel \/ Amtagvi) - pa\u0161laik V\u0101cij\u0101 NAV kompens\u0113jama.<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>T\u0101 ir svar\u012bg\u0101k\u0101 pa\u0161reiz\u0113j\u0101 at\u0161\u0137ir\u012bba sal\u012bdzin\u0101jum\u0101 ar ASV.<\/p>\n\n\n\n<p>Uz\u0146\u0113mums <em>Iovance<\/em> 2025. gada 22. j\u016blij\u0101 atsauca EMA iesniegto tirdzniec\u012bbas at\u013caujas pieteikumu. <\/p>\n\n\n\n<p>EMA bija ba\u017eas par atbildes reakcijas bie\u017eumu galvenaj\u0101 p\u0113t\u012bjum\u0101, k\u0101 ar\u012b nopietnas ba\u017eas par dro\u0161\u012bbu, jo da\u017eos gad\u012bjumos terapija bija saist\u012bta ar n\u0101ves gad\u012bjumiem.<br>Turkl\u0101t ra\u017eot\u0101jam nebija pietiekamas LRP dokument\u0101cijas. <a href=\"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.2025.43.16_suppl.TPS2673\" target=\"_blank\" rel=\"noreferrer noopener\">Amerikas Kl\u012bnisk\u0101s onkolo\u0123ijas biedr\u012bba<\/a><\/p>\n\n\n\n<p>Pa\u0161laik Iovance kop\u0101 ar EMA izstr\u0101d\u0101 jaunu strat\u0113\u0123iju, lai sa\u0146emtu ES tirdzniec\u012bbas at\u013cauju Amtagvi. Apvienotaj\u0101 Karalist\u0113 apstiprin\u0101jums ir gaid\u0101ms 2026. gada pirmaj\u0101 pus\u0113; Austr\u0101lij\u0101 ir pie\u0161\u0137irts priorit\u0101rais izv\u0113rt\u0113jums. <a href=\"https:\/\/www.globenewswire.com\/de\/news-release\/2025\/03\/27\/3050384\/0\/en\/Immatics-Announces-Full-Year-2024-Financial-Results-and-Business-Update.html\" target=\"_blank\" rel=\"noreferrer noopener\">GlobeNewswire<\/a><\/p>\n\n\n\n<p><strong>Secin\u0101jums par V\u0101ciju:<\/strong> Lifileucel pa\u0161laik ir pieejams ES. <strong>Nav at\u013cauts un nav atl\u012bdzin\u0101ms<\/strong>. Pacientiem, kuri v\u0113las sa\u0146emt \u0161o terapiju, pa\u0161laik t\u0101 j\u0101sa\u0146em ASV par saviem l\u012bdzek\u013ciem vai kl\u012bnisko p\u0113t\u012bjumu ietvaros.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"TCR-T-Therapien_Afami-cel_Tecelra_%E2%80%93_In_Europa_nicht_zugelassen\"><\/span>TCR-T terapija (Afami-cel \/ Tecelra) - Eirop\u0101 nav at\u013cauta.<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Afamitresg\u0113ns autoleucela (Tecelra) pa\u0161laik ir <strong>at\u013cauts tikai ASV<\/strong> (FDA, 2024. gada augusts). EMA pieteikums v\u0113l nav iesniegts.<\/p>\n\n\n\n<p>T\u0101p\u0113c V\u0101cij\u0101 ir sp\u0113k\u0101 \u0161\u0101da k\u0101rt\u012bba: kompens\u0101ciju nav, regul\u0101ra piek\u013cuve nav iesp\u0113jama, tikai ar kl\u012bnisko p\u0113t\u012bjumu vai individu\u0101lu terapeitisko p\u0113t\u012bjumu starpniec\u012bbu (k\u0101 Mailo gad\u012bjum\u0101 KiTZ Heidelberg\u0101).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Was_tun_wenn_die_Kasse_ablehnt_Rechtliche_Moglichkeiten\"><\/span>Ko dar\u012bt, ja apdro\u0161in\u0101\u0161anas sabiedr\u012bba atsaka? Juridisk\u0101s iesp\u0113jas<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Ja oblig\u0101tais vesel\u012bbas apdro\u0161in\u0101t\u0101js atsak\u0101s segt EMA apstiprin\u0101t\u0101s terapijas izmaksas, ir pieejamas \u0161\u0101das iesp\u0113jas:<\/p>\n\n\n\n<p><strong>Iebildumi (SGB V 78. pants)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Iesniegt rakstisku iebildumu 4 ned\u0113\u013cu laik\u0101 p\u0113c noraid\u012bjuma.<\/li>\n\n\n\n<li>Kl\u012bnikai un \u0101rstam j\u0101pievieno detaliz\u0113ts medic\u012bniskais zi\u0146ojums.<\/li>\n<\/ul>\n\n\n\n<p><strong>Soci\u0101l\u0101 tiesved\u012bba<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ja l\u0113mums joproj\u0101m ir negat\u012bvs, iesniedziet s\u016bdz\u012bbu kompetentaj\u0101 soci\u0101laj\u0101 ties\u0101.<\/li>\n\n\n\n<li>Dz\u012bv\u012bbai b\u012bstamu slim\u012bbu gad\u012bjum\u0101. <strong>pagaidu tiesisk\u0101 aizsardz\u012bba<\/strong> var pieteikties, <br>tiesa var provizoriski piespriest uz\u0146emties ties\u0101\u0161an\u0101s izdevumus.<\/li>\n<\/ul>\n\n\n\n<p><strong>\u00a7 SGB V 2. panta 1.a punkts (Nikolaus rezol\u016bcija)<\/strong><\/p>\n\n\n\n<p>Dz\u012bv\u012bbai b\u012bstamas slim\u012bbas gad\u012bjum\u0101, ja nav pieejama standarta terapija, apdro\u0161in\u0101taj\u0101m person\u0101m ir ties\u012bbas uz nestandarta at\u013cautu terapiju, ja ir nopietnas izredzes iz\u0101rst\u0113ties vai j\u016btami atvieglot st\u0101vokli. Tas ir galvenais juridiskais instruments t\u0101dos gad\u012bjumos k\u0101 individu\u0101li \u0101rst\u0113\u0161anas m\u0113\u0123in\u0101jumi.<\/p>\n\n\n\n<p><strong>Svar\u012bgi resursi:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.g-ba.de\/themen\/arzneimittel\/arzneimittel-richtlinie-anlagen\/nutzenbewertung-131e\/\" target=\"_blank\" rel=\"noopener\">Im\u016bn\u0161\u016bnu terapijas G-BA ieguvumu nov\u0113rt\u0113jumi<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.dgho.de\/arbeitskreise\/a-g\/drg-gesundheitsoekonomie\/nub-2025\/nub-2025\" target=\"_blank\" rel=\"noopener\">DGHO NUB veidnes 2025<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.krebsinformationsdienst.de\/fachkreise\/nachrichten\/detail\/update-car-t-zell-therapie\" target=\"_blank\" rel=\"noopener\">DKFZ V\u0113\u017ea inform\u0101cijas dienests - CAR-T un GKV<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/pharma-fakten.de\/news\/car-t-zelltherapie-woran-es-noch-fehlt\/\" target=\"_blank\" rel=\"noopener\">Farm\u0101cijas fakti: Birokr\u0101tijas probl\u0113ma CAR-T<\/a><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Osterreich\"><\/span>Austrija<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Austrija:<\/strong> CAR-T \u0161\u016bnu terapija tika iek\u013cauta LKF pakalpojumu katalog\u0101 Austrij\u0101 2020. gada 1. janv\u0101r\u012b (grupa MEL22.30: \u201eModific\u0113tu \u0161\u016bnu ievad\u012b\u0161ana\u201c) - t\u0101tad regul\u0113ta agr\u0101k un skaidr\u0101k nek\u0101 V\u0101cij\u0101. <a href=\"https:\/\/www.clinicaltrialvanguard.com\/news\/t-knife-files-for-phase-1-trial-of-prame-t-cell-therapy\/\" target=\"_blank\" rel=\"noreferrer noopener\">Clinicaltrialvanguard<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Schweiz\"><\/span>\u0160veice<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>\u0160veice:<\/strong> Kompens\u0101cija ar KVG (Vesel\u012bbas apdro\u0161in\u0101\u0161anas likums) starpniec\u012bbu p\u0113c iek\u013cau\u0161anas FOPH specialit\u0101\u0161u sarakst\u0101; EMA apstiprin\u0101tiem CAR-T produktiem princip\u0101 iesp\u0113jama, ar\u012b ar individu\u0101lu gad\u012bjumu izv\u0113rt\u0113\u0161anu.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Zusammenfassung\"><\/span>Kopsavilkums<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Terapija<\/th><th>ES at\u013cauja<\/th><th>SHI atl\u012bdz\u012bba V\u0101cija<\/th><\/tr><\/thead><tbody><tr><td>CAR-T (Kymriah, Yescarta, Tecartus, Breyanzi, Abecma, Carvykti)<\/td><td>J\u0101 (EMA)<\/td><td>B\u016bt\u012bb\u0101 j\u0101, bet ar individu\u0101lu pieteikumu\/NUB, kas saist\u012bts ar iev\u0113rojamu birokr\u0101tiju.<\/td><\/tr><tr><td>Krimuldas novadp\u0113tniec\u012bbas centrs (Tebentafusp)<\/td><td>J\u0101 (EMA)<\/td><td>J\u0101 (AMNOG proced\u016bra, ambulatori)<\/td><\/tr><tr><td>Lifileucel \/ Amtagvi (TIL)<\/td><td>N\u0113 (EMA pieteikums atsaukts 2025. gada j\u016blij\u0101)<\/td><td>N\u0113<\/td><\/tr><tr><td>Afami-cel \/ Tecelra (TCR-T)<\/td><td>N\u0113 (tikai FDA)<\/td><td>N\u0113<\/td><\/tr><tr><td>PRAME-TCR (IMA203, eksperiment\u0101ls)<\/td><td>N\u0113 (3. posms)<\/td><td>N\u0113 - tikai piedaloties p\u0113t\u012bjum\u0101<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Galven\u0101 politisk\u0101 probl\u0113ma joproj\u0101m ir aktu\u0101la: L\u012bdz \u0161im nav patiesi laba tiesisk\u0101 un finansi\u0101l\u0101 regul\u0113juma, kas \u013cautu \u0101tri un uzticami atspogu\u013cot \u0161\u012bs inovat\u012bv\u0101s terapijas V\u0101cijas sist\u0113m\u0101. Var paiet vair\u0101ki gadi, l\u012bdz medic\u012bnisko inov\u0101ciju izmaksas tiek pareizi atspogu\u013cotas vienotas likmes par katru gad\u012bjumu sist\u0113m\u0101.<\/p>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"PKV_und_Immunzelltherapie_%E2%80%93_Die_vollstandige_Rechtslage\"><\/span>PKV un im\u016bn\u0161\u016bnu terapija - piln\u012bga juridisk\u0101 situ\u0101cija<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Statuss: 2026. gada febru\u0101ris<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Das_rechtliche_Fundament_%C2%A7_192_VVG_und_MBKK_2009\"><\/span>Juridiskais pamats: VVG 192. pants un MB\/KK 2009. gads<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0100rstniec\u012bbas izdevumu apdro\u0161in\u0101\u0161anas gad\u012bjum\u0101 apdro\u0161in\u0101t\u0101jam ir pien\u0101kums atl\u012bdzin\u0101t izdevumus par medic\u012bniski nepiecie\u0161amo \u0101rst\u0113\u0161anu slim\u012bbas vai nelaimes gad\u012bjuma seku d\u0113\u013c t\u0101d\u0101 apm\u0113r\u0101, par k\u0101du ir pan\u0101kta vieno\u0161an\u0101s. Apdro\u0161in\u0101t\u0101jam nav pien\u0101kuma izmaks\u0101t apdro\u0161in\u0101\u0161anas atl\u012bdz\u012bbu, ja izdevumi par \u0101rst\u0113\u0161anu vai cit\u0101m atl\u012bdz\u012bb\u0101m ir ac\u012bmredzami nesam\u0113r\u012bgi ar pie\u0161\u0137irtaj\u0101m atl\u012bdz\u012bb\u0101m.<\/p>\n\n\n\n<p><strong>Juridiskais formul\u0113jums \u00a7 192 VVG (pabeigts):<\/strong> <a href=\"https:\/\/dejure.org\/gesetze\/VVG\/192.html\" target=\"_blank\" rel=\"noopener\">dejure.org - VVG 192. pants Tipiski apdro\u0161in\u0101t\u0101ja l\u012bgumiskie labumi<\/a><\/p>\n\n\n\n<p><strong>Ofici\u0101lie parauga nosac\u012bjumi MB\/KK 2009 (PDF, PKV-Verband):<\/strong> <a href=\"https:\/\/www.pkv.de\/fileadmin\/user_upload\/PKV\/3_PDFs\/ABV_und_MB\/MB-KK.pdf\" target=\"_blank\" rel=\"noopener\">pkv.de - MB\/KK 2009 parauga nosac\u012bjumi<\/a><\/p>\n\n\n\n<p>Priv\u0101to vesel\u012bbas apdro\u0161in\u0101t\u0101ju saist\u012bbas sniegt pabalstus b\u016bt\u012bb\u0101 nosaka katr\u0101 atsevi\u0161\u0137\u0101 gad\u012bjum\u0101 izv\u0113l\u0113tais tarifs un ar to saist\u012btie tarifa nosac\u012bjumi. Saska\u0146\u0101 ar VVG 192. panta 1. punktu saist\u012bb\u0101 ar MB\/KK tiek atl\u012bdzin\u0101ti izdevumi par medic\u012bniski nepiecie\u0161amo \u0101rst\u0113\u0161anu slim\u012bbas vai nelaimes gad\u012bjuma seku d\u0113\u013c.<\/p>\n\n\n\n<p><strong>Paskaidrojums par PKV pabalsta saist\u012bb\u0101m saska\u0146\u0101 ar VVG 192. pantu:<\/strong> <a href=\"https:\/\/www.legal-plus.eu\/die-leistungspflicht-der-privaten-krankenversicherung-pkv-wann-und-wofuer-muss-die-pkv-zahlen\/\" target=\"_blank\" rel=\"noopener\">legal-plus.eu - PKV maks\u0101\u0161anas pien\u0101kums: kad un par ko PKV ir j\u0101maks\u0101?<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Der_Schlusselbegriff_%E2%80%9EMedizinisch_notwendige_Heilbehandlung%E2%80%9C\"><\/span>Galvenais termins: \u201emedic\u012bniski nepiecie\u0161ama \u0101rst\u0113\u0161ana\u201c.\u201c<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Saska\u0146\u0101 ar iedibin\u0101to tiesu praksi un atbilsto\u0161i MB\/KK un VVG 192. panta paraugnoteikumiem medic\u012bnisk\u0101 nepiecie\u0161am\u012bba past\u0101v, ja \u0101rst\u0113\u0161ana saska\u0146\u0101 ar objekt\u012bviem medic\u012bniskiem atzinumiem un zin\u0101\u0161an\u0101m ir piem\u0113rota, lai atpaz\u012btu un iz\u0101rst\u0113tu slim\u012bbu, nov\u0113rstu t\u0101s pasliktin\u0101\u0161anos vai atvieglotu simptomus. Iz\u0161\u0137iro\u0161ais faktors ir tas, vai \u0101rst\u0113\u0161anas laik\u0101 kompetenta \u0101rsta atzinum\u0101 pas\u0101kums \u0161\u0137iet nepiecie\u0161ams saska\u0146\u0101 ar atz\u012btiem zin\u0101tniskiem standartiem.<\/p>\n\n\n\n<p><strong>Juridisk\u0101 anal\u012bze: medic\u012bnisk\u0101s nepiecie\u0161am\u012bbas defin\u012bcija priv\u0101taj\u0101 vesel\u012bbas apdro\u0161in\u0101\u0161an\u0101:<\/strong> <a href=\"https:\/\/kanzlei-neue-kraeme.de\/erstattung-kostenintensiver-behandlungsmassnahmen-in-der-pkv\/\" target=\"_blank\" rel=\"noopener\">kanzlei-neue-kraeme.de - Izmaksu ietilp\u012bgu \u0101rst\u0113\u0161anas pas\u0101kumu kompens\u0113\u0161ana priv\u0101taj\u0101 vesel\u012bbas apdro\u0161in\u0101\u0161an\u0101<\/a><\/p>\n\n\n\n<p>Papildus tradicion\u0101laj\u0101 medic\u012bn\u0101 atz\u012btiem \u0101rst\u0113\u0161anas veidiem priv\u0101t\u0101 vesel\u012bbas apdro\u0161in\u0101\u0161ana atl\u012bdzina ar\u012b \u0101rst\u0113\u0161anas veidus, kas praks\u0113 ir izr\u0101d\u012bju\u0161ies vienl\u012bdz daudzsolo\u0161i vai kam nav alternat\u012bvas. Tie var b\u016bt ar\u012b jauni medikamenti vai inovat\u012bvas diagnostikas proced\u016bras un \u0101rst\u0113\u0161anas metodes, ko eksperti uzskata par lietder\u012bg\u0101m.<\/p>\n\n\n\n<p><strong>PKV asoci\u0101cija: Ofici\u0101ls skaidrojums par pabalstiem un kompens\u0101ciju (tostarp inovat\u012bv\u0101m terapij\u0101m):<\/strong> <a href=\"https:\/\/www.pkv.de\/wissen\/private-krankenversicherung\/leistungen-und-erstattung\/\" target=\"_blank\" rel=\"noopener\">pkv.de - Pabalsti un atl\u012bdz\u012bba priv\u0101taj\u0101 vesel\u012bbas apdro\u0161in\u0101\u0161an\u0101<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Das_Richtungsurteil_OLG_Frankfurt_29062022_%E2%80%93_Az_7_U_14021\"><\/span>Galvenais spriedums: OLG Frankfurt, 29.06.2022. - Ref. 7 U 140\/21.<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Tas ir galvenais spriedums attiec\u012bb\u0101 uz im\u016bn\u0161\u016bnu terapijas kompens\u0101ciju no priv\u0101t\u0101s vesel\u012bbas apdro\u0161in\u0101\u0161anas V\u0101cij\u0101.<\/p>\n\n\n\n<p><strong>Lietas fakti<\/strong><br>Pacientam tika diagnostic\u0113ts neoper\u0113jams aizku\u0146\u0123a dziedzera audz\u0113js. P\u0113c neveiksm\u012bgas \u0137\u012bmijterapijas vi\u0146\u0161 nol\u0113ma atteikties no standarta paliat\u012bv\u0101s terapijas, kuras prognozes bija slikt\u0101kas, un t\u0101 viet\u0101 izv\u0113l\u0113j\u0101s dendr\u012bt\u0161\u016bnu terapiju. Vi\u0146\u0161 v\u0113l\u0113j\u0101s piepras\u012bt segt izdevumus no savas priv\u0101t\u0101s vesel\u012bbas apdro\u0161in\u0101\u0161anas sabiedr\u012bbas, ta\u010du t\u0101 atteic\u0101s apmaks\u0101t tos piln\u0101 apm\u0113r\u0101.<\/p>\n\n\n\n<p><strong>Spriedums<\/strong><br>Dendr\u012bt\u0161\u016bnu terapija ir \u0101rst\u0113\u0161ana priv\u0101to vesel\u012bbas apdro\u0161in\u0101\u0161anas sabiedr\u012bbu medic\u012bnisko izmaksu nosac\u012bjumu (MB\/KK 2009) izpratn\u0113. Ja tradicion\u0101l\u0101 pirm\u0101s l\u012bnijas terapija nesniedz v\u0113lamos \u0101rst\u0113\u0161anas pan\u0101kumus personai, kas slimo ar dz\u012bv\u012bbai b\u012bstamu un ne\u0101rst\u0113jamu audz\u0113ju, apdro\u0161in\u0101t\u0101 persona nav j\u0101nos\u016bta uz otr\u0101s l\u012bnijas terapiju, kuras efektivit\u0101tes prognoze ir v\u0113l zem\u0101ka. Dr\u012bz\u0101k vi\u0146i var piepras\u012bt tie\u0161u jaunas, zin\u0101tniski pamatotas alternat\u012bvas terapijas izmaksu seg\u0161anu, ja \u0101rst\u0113\u0161anas laik\u0101 t\u0101 sniedz ne glu\u017ei niec\u012bgas izredzes g\u016bt pan\u0101kumus papildus standarta paliat\u012bvai terapijai.<\/p>\n\n\n\n<p><strong>Pilna sprieduma apsprie\u0161ana (DATEV Magazin):<\/strong> <a href=\"https:\/\/www.datev-magazin.de\/nachrichten-steuern-recht\/recht\/private-krankenversicherung-muss-bei-inoperablem-tumor-nach-gescheiterter-chemotherapie-kosten-einer-alternativtherapie-mit-dendritischen-zellen-tragen-81762\" target=\"_blank\" rel=\"noopener\">datev-magazin.de - OLG Frankfurt\u0113: PKV j\u0101sedz dendr\u012bt\u0161\u016bnu terapijas izmaksas<\/a><\/p>\n\n\n\n<p><strong>Sprieduma p\u0101rskat\u012b\u0161ana ar juridisk\u0101 sp\u0113ka apstiprin\u0101\u0161anu (2023. gada janv\u0101ris):<\/strong> <a href=\"https:\/\/transkript.de\/artikel\/2023\/krankenkasse-muss-zelltherapie-zahlen\/\" target=\"_blank\" rel=\"noopener\">transkript.de - Vesel\u012bbas apdro\u0161in\u0101\u0161anas sabiedr\u012bbai j\u0101maks\u0101 par \u0161\u016bnu terapiju (ieskaitot juridisk\u0101 sp\u0113ka apstiprin\u0101jumu)<\/a><\/p>\n\n\n\n<p><strong>Slimn\u012bcu spriedumu anal\u012bze (IWW Verg\u00fctungsrecht):<\/strong> <a href=\"https:\/\/www.iww.de\/cb\/recht\/verguetungsrecht-schulmedizinische-behandlung-erfolglos-pkvmuss-kosten-der-alternativtherapie-tragen-f149155\" target=\"_blank\" rel=\"noopener\">iww.de - PKV j\u0101sedz alternat\u012bv\u0101s terapijas izmaksas<\/a><\/p>\n\n\n\n<p><strong>Haufe: \u012ass sprieduma kopsavilkums:<\/strong> <a href=\"https:\/\/www.haufe.de\/recht\/weitere-rechtsgebiete\/inoperabler-tumor-uebernahme-von-alternativtherapie-durch-pkv_216_571650.html\" target=\"_blank\" rel=\"noopener\">haufe.de - Neoper\u0113jams audz\u0113js: alternat\u012bv\u0101 terapija, ko sedz PKV<\/a><\/p>\n\n\n\n<p><strong>Detaliz\u0113ta sprieduma anal\u012bze (J\u00f6hnke &amp; Reichow Rechtsanw\u00e4lte):<\/strong> <a href=\"https:\/\/joehnke-reichow.de\/2024\/07\/17\/kostenerstattung-bei-einer-dendritischen-zellbehandlung-olg-frankfurt\/\" target=\"_blank\" rel=\"noopener\">joehnke-reichow.de - Izdevumu atl\u012bdzin\u0101\u0161ana par dendr\u012btisko \u0161\u016bnu \u0101rst\u0113\u0161anu, OLG Frankfurt\u0113<\/a><\/p>\n\n\n\n<p><strong>Juridiskais sp\u0113ks:<\/strong> Saska\u0146\u0101 ar Hesenes Augst\u0101k\u0101s apgabaltiesas sniegto inform\u0101ciju apel\u0101cijas iesnieg\u0161anas termi\u0146\u0161 ir beidzies, kas noz\u012bm\u0113, ka l\u0113mums ir juridiski saisto\u0161s kop\u0161 2023. gada janv\u0101ra.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Das_%E2%80%9Eauffallige_Missverhaltnis%E2%80%9C_nach_%C2%A7_192_Abs_2_VVG_%E2%80%93_und_warum_es_bei_CAR-T_nicht_greift\"><\/span>\u201eAc\u012bmredzama disproporcija\u201c saska\u0146\u0101 ar VVG 192. panta 2. punktu - un k\u0101p\u0113c t\u0101 neattiecas uz CAR-T<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Pien\u0101kums iesniegt un pier\u0101d\u012bt uzkr\u012bto\u0161as disproporcijas esam\u012bbu ir apdro\u0161in\u0101t\u0101jam. Past\u0101v vienpr\u0101t\u012bba, ka iz\u0161\u0137iro\u0161a ir sniegt\u0101 pakalpojuma parast\u0101 v\u0113rt\u012bba, nevis minim\u0101l\u0101 medic\u012bnisk\u0101 standarta cena. Piem\u0113rojot Feder\u0101l\u0101s tiesas judikat\u016bru par aug\u013co\u0161anas p\u0101rk\u0101pumiem, tirgus sal\u012bdzin\u0101jums ir piem\u0113rots l\u012bdzeklis objekt\u012bv\u0101s v\u0113rt\u012bbas noteik\u0161anai.<\/p>\n\n\n\n<p>T\u0101 k\u0101 CAR-T terapiju cenas vis\u0101 pasaul\u0113 ir sal\u012bdzin\u0101mas (250 000-600 000 EUR), \u201euzkr\u012bto\u0161o nel\u012bdzsvarot\u012bbu\u201c var atsp\u0113kot, sal\u012bdzinot starptautisko tirgu.<\/p>\n\n\n\n<p><strong>\u201eAc\u012bmredzamas disproporcijas\u201c juridisk\u0101 anal\u012bze saska\u0146\u0101 ar VVG 192. panta 2. punktu:<\/strong> <a href=\"https:\/\/www.kunzrechtsanwaelte.de\/aktuelles\/urteile\/versicherung-und-haftung\/krankenversicherung\" target=\"_blank\" rel=\"noopener\">kunzrechtsanwaelte.de - Par uzkr\u012bto\u0161u disproporciju VVG 192. panta 2. punkta izpratn\u0113<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Das_Voranfrageverfahren_nach_%C2%A7_192_Abs_8_VVG_%E2%80%93_der_wichtigste_praktische_Schritt\"><\/span>Iepriek\u0161\u0113jas izmekl\u0113\u0161anas proced\u016bra saska\u0146\u0101 ar VVG 192. panta 8. punktu - vissvar\u012bg\u0101kais praktiskais solis<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Tikl\u012bdz ir paredzams, ka paredzam\u0101s \u0101rst\u0113\u0161anas izmaksas p\u0101rsniegs 2000 EUR, apdro\u0161in\u0101taj\u0101m person\u0101m ir ties\u012bbas sa\u0146emt inform\u0101ciju par izmaksu saist\u012bb\u0101m saska\u0146\u0101 ar VVG 192. panta 8. punktu. Apdro\u0161in\u0101\u0161anas sabiedr\u012bbai 4 ned\u0113\u013cu laik\u0101 p\u0113c izmaksu t\u0101mes iesnieg\u0161anas ir j\u0101apstiprina vai j\u0101noraida izmaksu uz\u0146em\u0161an\u0101s.<\/p>\n\n\n\n<p>Ja inform\u0101cija netiek sniegta noteiktaj\u0101 termi\u0146\u0101, apdro\u0161in\u0101t\u0101js pie\u0146em, ka paredz\u0113t\u0101 \u0101rst\u0113\u0161ana ir nepiecie\u0161ama, l\u012bdz tiek pier\u0101d\u012bts pret\u0113jais. \u0160is <strong>Nepiecie\u0161am\u012bbas fikcija<\/strong> neatbild\u0113\u0161anas gad\u012bjum\u0101 ir svar\u012bgs pacientu aizsardz\u012bbas instruments.<\/p>\n\n\n\n<p><strong>VVG 192. panta 8. punkta redakcija (pien\u0101kums iepriek\u0161 noskaidrot inform\u0101ciju):<\/strong> <a href=\"https:\/\/dejure.org\/gesetze\/VVG\/192.html\" target=\"_blank\" rel=\"noopener\">dejure.org - VVG 192. panta 8. punkts<\/a><\/p>\n\n\n\n<p><strong>Praktiski nor\u0101d\u012bjumi: Iepriek\u0161\u0113ja izmekl\u0113\u0161ana ar PKV pirms izmaksu zi\u0146\u0101 intens\u012bvas \u0101rst\u0113\u0161anas:<\/strong> <a href=\"https:\/\/www.pkv-inhalte.de\/pkv-bu-av-blog\/pkv-versichert-und-teure-behandlung-steht-bevor-wie-geht-man-richtig-vor\/\" target=\"_blank\" rel=\"noopener\">pkv-inhalte.de - PKV apdro\u0161in\u0101\u0161ana un d\u0101rga \u0101rst\u0113\u0161ana: k\u0101da ir pareiz\u0101 pieeja?<\/a><\/p>\n\n\n\n<p><strong>Nepareizas vai tr\u016bksto\u0161as PKV inform\u0101cijas juridisk\u0101s sekas:<\/strong> <a href=\"https:\/\/www.versicherungsrechtsiegen.de\/krankenhauskosten-zusatzversicherung-kostenerstattung-fuer-aufenthalt-in-privatklinik\/\" target=\"_blank\" rel=\"noopener\">versicherungsrechtsiegen.de - Izmaksu saist\u012bbas un VVG 192. panta 8. punkts praks\u0113<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Bei_Ablehnung_Rechtsmittel_und_Klage\"><\/span>Atteikuma gad\u012bjum\u0101: p\u0101rs\u016bdz\u012bba un tiesved\u012bba.<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Atl\u012bdzin\u0101\u0161anas jaut\u0101jumu nosaka VVG 192. panta, MB\/KK parauga nosac\u012bjumu un atsevi\u0161\u0137u tarifu klauzulu mijiedarb\u012bba. Iz\u0161\u0137iro\u0161ais faktors ir tas, vai \u0101rst\u0113\u0161ana tika veikta slim\u012bbas d\u0113\u013c un vai t\u0101 bija medic\u012bniski nepiecie\u0161ama.<\/p>\n\n\n\n<p>Ja PKV noraida pieteikumu, ir pieejamas \u0161\u0101das iesp\u0113jas:<\/p>\n\n\n\n<p><strong>Iebildums ar pilnu medic\u012bnisko dokument\u0101ciju<\/strong> (\u0101rsta atzinums, audz\u0113ju komisijas protokols, starptautisk\u0101 p\u0113t\u012bjuma situ\u0101cija, izmaksu apl\u0113se)<\/p>\n\n\n\n<p><strong>Pras\u012bba civilties\u0101<\/strong> (nevis soci\u0101l\u0101 tiesa, t\u0101 ir at\u0161\u0137ir\u012bba no likum\u0101 noteikt\u0101s vesel\u012bbas apdro\u0161in\u0101\u0161anas) ar pieteikumu par pagaidu noregul\u0113juma r\u012bkojumu steidzamas \u0101rst\u0113\u0161anas nepiecie\u0161am\u012bbas gad\u012bjum\u0101.<\/p>\n\n\n\n<p><strong>Piln\u012bga rokasgr\u0101mata: PKV atteikuma apstr\u012bd\u0113\u0161ana, iebildums un tiesved\u012bba:<\/strong> <a href=\"https:\/\/kanzlei-neue-kraeme.de\/erstattung-kostenintensiver-behandlungsmassnahmen-in-der-pkv\/\" target=\"_blank\" rel=\"noopener\">kanzlei-neue-kraeme.de - Priv\u0101t\u0101s vesel\u012bbas apdro\u0161in\u0101\u0161anas izmaksu ietilp\u012bgas \u0101rst\u0113\u0161anas atl\u012bdzin\u0101\u0161ana<\/a><\/p>\n\n\n\n<p><strong>Atteik\u0161an\u0101s no priv\u0101t\u0101s vesel\u012bbas apdro\u0161in\u0101\u0161anas un pabalstiem: juridiskie so\u013ci \u012bsum\u0101:<\/strong> <a href=\"https:\/\/kva-plus.de\/ablehnung-der-kostenuebernahme-durch-die-pkv-und-beihilfe\/\" target=\"_blank\" rel=\"noopener\">kva-plus.de - Atteik\u0161an\u0101s no izmaksu seg\u0161anas no priv\u0101t\u0101s vesel\u012bbas apdro\u0161in\u0101\u0161anas un valsts atbalsta<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p><span class=\"span-reading-time rt-reading-time\" style=\"display: block;\"><span class=\"rt-label rt-prefix\">Las\u012b\u0161anas laiks<\/span> <span class=\"rt-time\"> 20<\/span> <span class=\"rt-label rt-postfix\">protokols<\/span><\/span>Das Immunsystem &#8211; was macht das? Das Immunsystem unterh\u00e4lt eine ganze Armee von Kundschaftern, K\u00e4mpfern (T-Zellen) und Helfern. Sie patrouillieren st\u00e4ndig durch den K\u00f6rper und suchen nach Eindringlingen, wie Bakterien, Viren, aber auch wild gewordene k\u00f6rpereigene Zellen &#8211; Krebszellen. Normalerweise werden solch randalierende Zellen von den W\u00e4chtern des immunsystems schnell entdeckt, abget\u00f6tet, deren \u00dcberreste abtransportiert&hellip;&nbsp;<a href=\"https:\/\/csiag.eu\/lv\/blog\/2026\/02\/19\/immunzelltherapie\/\" rel=\"bookmark\">Las\u012bt vair\u0101k \"<span class=\"screen-reader-text\">Im\u016bn\u0161\u016bnu terapija<\/span><\/a><\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_lmt_disableupdate":"","_lmt_disable":"","neve_meta_sidebar":"","neve_meta_container":"","neve_meta_enable_content_width":"","neve_meta_content_width":0,"neve_meta_title_alignment":"","neve_meta_author_avatar":"","neve_post_elements_order":"","neve_meta_disable_header":"","neve_meta_disable_footer":"","neve_meta_disable_title":"","footnotes":""},"categories":[5584,1078,354],"tags":[],"class_list":["post-12789","post","type-post","status-publish","format-standard","hentry","category-krebs","category-medizin","category-medizin-gesundheit"],"modified_by":"Achim Goerner","_links":{"self":[{"href":"https:\/\/csiag.eu\/lv\/wp-json\/wp\/v2\/posts\/12789","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/csiag.eu\/lv\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csiag.eu\/lv\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csiag.eu\/lv\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/csiag.eu\/lv\/wp-json\/wp\/v2\/comments?post=12789"}],"version-history":[{"count":0,"href":"https:\/\/csiag.eu\/lv\/wp-json\/wp\/v2\/posts\/12789\/revisions"}],"wp:attachment":[{"href":"https:\/\/csiag.eu\/lv\/wp-json\/wp\/v2\/media?parent=12789"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csiag.eu\/lv\/wp-json\/wp\/v2\/categories?post=12789"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csiag.eu\/lv\/wp-json\/wp\/v2\/tags?post=12789"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}