{"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":"imuniniu-lasteliu-terapija","status":"publish","type":"post","link":"https:\/\/csiag.eu\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/","title":{"rendered":"Imunini\u0173 l\u0105steli\u0173 terapija"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_87_1 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\">Turinys<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Das_Immunsystem_%E2%80%93_was_macht_das\" >K\u0105 veikia imunin\u0117 sistema?<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Was_Immunzelltherapie_macht\" >K\u0105 veikia imunini\u0173 l\u0105steli\u0173 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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Das_Geniale_daran\" >Jo genialumas<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Die_drei_Typen_%E2%80%93_ganz_einfach\" >Trys tipai - labai paprasta<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#T-Zellen_und_ihre_Rolle\" >T l\u0105stel\u0117s ir j\u0173 vaidmuo<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Tumorimmunologie-Grundprinzip\" >Pagrindinis navik\u0173 imunologijos principas<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#CAR-T-Zelltherapie_%E2%80%93_Konstruktion_und_Mechanismus\" >CAR-T l\u0105steli\u0173 terapija - dizainas ir mechanizmas<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Molekularer_Aufbau_des_CAR\" >CAR molekulin\u0117 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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Herstellungsprozess_Autolog\" >Gamybos procesas (autologas)<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Wirkmechanismus_Effektorphase\" >Veikimo mechanizmas ir efektoriaus faz\u0117<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#TCR-T-Zelltherapie_Die_entscheidenden_Unterschiede\" >TCR-T l\u0105steli\u0173 terapija: pagrindiniai skirtumai<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Warum_TCR_und_nicht_CAR_fur_intrazellulare_Antigene\" >Kod\u0117l TCR, o ne CAR vidul\u0105steliniams antigenams?<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Struktur_des_therapeutischen_TCR\" >Terapinio 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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#TIL-Therapie_%E2%80%93_Prinzip_der_naturlichen_Tumorerkennung\" >TIL terapija - nat\u016bralaus naviko aptikimo principas<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Biologische_Grundlage\" >Biologinis pagrindas<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Herstellungsprozess_Lifileucel\" >Gamybos procesas (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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Herausforderungen_%E2%80%93_aktuelle_Forschungsansatze\" >I\u0161\u0161\u016bkiai - dabartiniai mokslini\u0173 tyrim\u0173 metodai<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Antigen-Escape\" >Antigeno pab\u0117gimas<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#T-Zell-Erschopfung_Exhaustion\" >T l\u0105steli\u0173 i\u0161sekimas (i\u0161sekimas)<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Tumormikroumgebung_TME\" >V\u0117\u017eio mikroaplinka (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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Zytokinsturm_CRS_ICANS\" >Citokin\u0173 audra (CRS) ir 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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Allogene_%E2%80%9EOff-the-shelf%E2%80%9C-Therapien\" >Alogeniniai \u201egatavi\u201c gydymo b\u016bdai<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#27_Quantitative_Wirksamkeitsdaten_im_Uberblick\" >2.7 Kiekybiniai efektyvumo duomenys i\u0161 pirmo \u017evilgsnio<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Weiterfuhrende_Literatur_Ressourcen\" >Papildoma literat\u016bra ir i\u0161tekliai<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Weltweit_zugelassene_Immunzelltherapien\" >Visame pasaulyje patvirtintos imunini\u0173 l\u0105steli\u0173 terapijos<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Einleitung_Die_drei_grosen_Klassen\" >\u012evadas: Trys pagrindin\u0117s klas\u0117s<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#CAR-T-ZELLTHERAPIEN\" >CAR-T L\u0104STELI\u0172 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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Tisagenlecleucel_Kymriah%C2%AE_%E2%80%93_Novartis\" >Tisagenoleukelis (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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Axicabtagene_Ciloleucel_Yescarta%C2%AE_%E2%80%93_KiteGilead\" >Aksikabtageno ciloleucelis (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\/lt\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Lisocabtagene_Maraleucel_Breyanzi%C2%AE_%E2%80%93_Bristol_Myers_Squibb\" >Lisocabtagenas 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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Idecabtagene_Vicleucel_Abecma%C2%AE_%E2%80%93_Bristol_Myers_Squibb_2seventy_bio\" >Idekabtagenas 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\/lt\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Obecabtagene_Autoleucel_Aucatzyl%C2%AE_%E2%80%93_Autolus_neu_112024\" >Obecabtagene Autoleucel (Aucatzyl\u00ae) - Autolus (nauja: 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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#WELTWEIT_ZUGELASSEN_%E2%80%93_NICHT_IN_USAEU_weitere_Lander\" >Leid\u017eiama visame pasaulyje - NE JAV\/ES (kitose \u0161alyse)<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#China_NMPA_%E2%80%93_vier_zusatzliche_CAR-T-Produkte\" >Kinija (NMPA) - keturi papildomi CAR-T produktai<\/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\/lt\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#TCR-T-ZELLTHERAPIEN_zugelassen\" >TCR-T L\u0105steli\u0173 terapija (leid\u017eiama)<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Afamitresgene_Autoleucel_Tecelra%C2%AE_%E2%80%93_Adaptimmune_August_2024\" >Afamitresgenas Autoleucel (Tecelra\u00ae) - \"Adaptimmune\" (2024 m. rugpj\u016btis)<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Tebentafusp-tebn_Kimmtrak%C2%AE_%E2%80%93_Immunocore_Januar_2022\" >Tebentafusp-tebn (Kimmtrak\u00ae) - Immunocore (2022 m. sausio m\u0117n.)<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#TIL-THERAPIE_zugelassen\" >TIL-TERAPIJA (leid\u017eiama)<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Lifileucel_Amtagvi%C2%AE_%E2%80%93_Iovance_Biotherapeutics_Februar_2024\" >\"Lifileucel\" (Amtagvi\u00ae) - \"Iovance Biotherapeutics\" (2024 m. vasaris)<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Ubersicht_aller_Immunzelltherapien_weltweit\" >Vis\u0173 pasaulyje taikom\u0173 imunini\u0173 l\u0105steli\u0173 terapij\u0173 ap\u017evalga<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Nebenwirkungen_%E2%80%93_Was_alle_Therapien_verbindet\" >\u0160alutinis poveikis - kas b\u016bdinga visiems gydymo b\u016bdams<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Wo_werden_diese_Therapien_in_Deutschland_angeboten\" >Kur Vokietijoje si\u016bloma \u0161i terapija?<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Ausblick_Was_kommt_als_nachstes\" >Perspektyvos: Kas toliau?<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#GKV-Erstattung_von_Immunzelltherapien_in_Deutschland\" >Imunini\u0173 l\u0105steli\u0173 terapijos kompensavimas Vokietijoje<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#CAR-T-Zelltherapien\" >CAR-T l\u0105steli\u0173 terapijos<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#AMNOG_NUB-Verfahren\" >AMNOG ir 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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Fruhe_Nutzenbewertung_durch_den_G-BA\" >G-BA atliekamas i\u0161ankstinis naudos vertinimas<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Preisverhandlung_nach_%C2%A7_130b_SGB_V\" >Derybos d\u0117l kainos pagal SGB 130b straipsn\u012f 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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#NUB-Verfahren_fur_Krankenhauser\" >NUB proced\u016bra ligonin\u0117ms<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Die_Realitat_Einzelfallantrage_und_Burokratie\" >Realyb\u0117: individualios parai\u0161kos ir biurokratija<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Das_%E2%80%9EPay-for-Outcome%E2%80%9C-Modell\" >\u201eMok\u0117jimo u\u017e rezultatus\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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Welche_CAR-T-Produkte_sind_in_Deutschland_erstattungsfahig\" >Kokie CAR-T preparatai gali b\u016bti kompensuojami Vokietijoje?<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Kimmtrak_Tebentafusp_%E2%80%93_Sonderfall\" >Kimmtrak (Tebentafusp) - ypatingas atvejis<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#TIL-Therapie_Lifileucel_Amtagvi_%E2%80%93_In_Deutschland_derzeit_NICHT_erstattungsfahig\" >TIL terapija (Lifileucel \/ Amtagvi) - \u0161iuo metu Vokietijoje nekompensuojama<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#TCR-T-Therapien_Afami-cel_Tecelra_%E2%80%93_In_Europa_nicht_zugelassen\" >TCR-T terapija (Afami-cel \/ Tecelra) - Europoje neleid\u017eiama taikyti<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Was_tun_wenn_die_Kasse_ablehnt_Rechtliche_Moglichkeiten\" >K\u0105 daryti, jei draudimo bendrov\u0117 atsisako? Teisin\u0117s galimyb\u0117s<\/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\/lt\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Schweiz\" >\u0160veicarija<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Zusammenfassung\" >Santrauka<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#PKV_und_Immunzelltherapie_%E2%80%93_Die_vollstandige_Rechtslage\" >PKV ir imunini\u0173 l\u0105steli\u0173 terapija - visa teisin\u0117 situacija<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Das_rechtliche_Fundament_%C2%A7_192_VVG_und_MBKK_2009\" >Teisinis pagrindas: 2009 m. VVG 192 straipsnis ir MB\/KK<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Der_Schlusselbegriff_%E2%80%9EMedizinisch_notwendige_Heilbehandlung%E2%80%9C\" >Pagrindin\u0117 s\u0105voka: \u201emedicini\u0161kai b\u016btinas gydymas\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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Das_Richtungsurteil_OLG_Frankfurt_29062022_%E2%80%93_Az_7_U_14021\" >Pagrindinis sprendimas: OLG Frankfurt, 2022 6 29 - 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\/lt\/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\" >\u201eAkivaizdi disproporcija\u201c pagal VVG 192 straipsnio 2 dal\u012f ir kod\u0117l ji netaikoma 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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Das_Voranfrageverfahren_nach_%C2%A7_192_Abs_8_VVG_%E2%80%93_der_wichtigste_praktische_Schritt\" >I\u0161ankstinio tyrimo proced\u016bra pagal VVG 192 straipsnio 8 dal\u012f - svarbiausias praktinis \u017eingsnis<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/#Bei_Ablehnung_Rechtsmittel_und_Klage\" >Atmetimo atveju: apeliacija ir ie\u0161kinys<\/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\">Skaitymo laikas<\/span> <span class=\"rt-time\"> 20<\/span> <span class=\"rt-label rt-postfix\">minut\u0117s<\/span><\/span>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Das_Immunsystem_%E2%80%93_was_macht_das\"><\/span>K\u0105 veikia imunin\u0117 sistema?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Imunin\u0117 sistema turi vis\u0105 armij\u0105 \u017evalg\u0173, kovotoj\u0173 (<em>T l\u0105stel\u0117s<\/em>) ir pagalbininkai. Jie nuolat patruliuoja organizme ir ie\u0161ko \u012fsibrov\u0117li\u0173, pavyzd\u017eiui, bakterij\u0173, virus\u0173, taip pat paties organizmo l\u0105steli\u0173, kurios i\u0161sigim\u0117 - v\u0117\u017eini\u0173 l\u0105steli\u0173.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u012eprastai imunin\u0117s sistemos serg\u0117tojai greitai aptinka tokias siaut\u0117jan\u010dias l\u0105steles, nu\u017eudo jas, o j\u0173 liekanas pa\u0161alina ir suardo. Tai vyksta nuolat kiekvien\u0105 dien\u0105. Taip imunin\u0117 sistema neleid\u017eia daugumai v\u0117\u017eini\u0173 l\u0105steli\u0173 plisti ir jos laiku tampa nekenksmingos.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ta\u010diau v\u0117\u017ein\u0117s l\u0105stel\u0117s yra i\u0161radingos, nes nori i\u0161gyventi bet kokia kaina. Tod\u0117l jos maskuojasi, efektyviai slepiasi nuo imunin\u0117s sistemos sarg\u0173 ir toliau plinta beveik nekontroliuojamos. Jos ne tik pasidaro neatpa\u017e\u012fstamos kaip prie\u0161as, bet ir taip u\u017eima imunin\u0119 sistem\u0105, kad po tam tikro laiko ji i\u0161seksta ir gali net i\u0161skleisti sparnus - ir pasiduoti v\u0117\u017eiui.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Was_Immunzelltherapie_macht\"><\/span>K\u0105 veikia imunini\u0173 l\u0105steli\u0173 terapija<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Imunini\u0173 l\u0105steli\u0173 terapijos metu imunin\u0117s l\u0105stel\u0117s paimamos i\u0161 paciento, apr\u016bpinamos, pavyzd\u017eiui, geresne atpa\u017einimo technologija, didesne kovine galia arba nauja \u201etaikinio optika\u201c ir gr\u0105\u017einamos \u012f organizm\u0105, kur gali tikslingiau atakuoti ir naikinti v\u0117\u017e\u012f.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Das_Geniale_daran\"><\/span>Jo genialumas<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Skirtingai nuo chemoterapijos, kuri i\u0161 esm\u0117s naikina visk\u0105, kas greitai dalijasi (viena vertus, v\u0117\u017eio l\u0105steles, bet taip pat - nety\u010dia - plauk\u0173 l\u0105steles, \u017earnyno l\u0105steles ir t. t.), imunini\u0173 l\u0105steli\u0173 terapija nukreipta \u012f <strong>tik v\u0117\u017ein\u0117ms l\u0105stel\u0117ms.<\/strong> - bent jau teori\u0161kai.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kadangi imunin\u0117 sistema atsimena atpa\u017eintus prie\u0161us, ji nedelsdama puola naujas v\u0117\u017eio l\u0105steles ir sunaikina jas, jei v\u0117\u017eys sugr\u012f\u017et\u0173. Tai paai\u0161kina, kod\u0117l kai kurie pacientai po vienos infuzijos visam laikui lieka be naviko.<\/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>Trys tipai - labai paprasta<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1 CAR-T l\u0105stel\u0117s: Keitimas<\/strong><br>Paimamos T l\u0105stel\u0117s (imunin\u0117s sistemos kovin\u0117 j\u0117ga) ir laboratorijoje joms sukuriama visi\u0161kai nauja \u201erankena\u201c - dirbtinis receptorius. Jis atpa\u017e\u012fsta labai specifin\u0119 v\u0117\u017ein\u0117s l\u0105stel\u0117s pavir\u0161iaus ypatyb\u0119 ir tiesiogiai sunaikina v\u0117\u017ein\u0119 l\u0105stel\u0119.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2 TCR T l\u0105stel\u0117s: Geresni akiniai<\/strong><br>Pana\u0161iai kaip ir CAR-T, vietoj dirbtinio griebtuvo T l\u0105stel\u0117 gauna patobulint\u0105 nat\u016bral\u0173 receptori\u0173, kuris taip pat atpa\u017e\u012fsta po\u017eymius, kurie yra giliai <em>viduje<\/em> v\u0117\u017ein\u0117s l\u0105stel\u0117s ir i\u0161or\u0117je matomi tik ma\u017ei fragmentai.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. TIL terapija: veteranas<\/strong><br>\u0160iuo atveju imamos T l\u0105stel\u0117s, kurios jau yra <em>pa\u010diame navike<\/em> ir pa\u017einti j\u012f. Jos i\u0161gaunamos, laboratorijoje masi\u0161kai padauginamos - i\u0161 keli\u0173 l\u0105steli\u0173 susidaro milijardai - ir siun\u010diamos atgal patyrusiems \u201eveteranams\u201c.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"T-Zellen_und_ihre_Rolle\"><\/span>T l\u0105stel\u0117s ir j\u0173 vaidmuo<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Adaptyviosios imunin\u0117s sistemos pagrind\u0105 sudaro du pagrindiniai l\u0105steli\u0173 tipai: <strong>B l\u0105stel\u0117s<\/strong> (antik\u016bn\u0173 gamyba) ir <strong>T l\u0105stel\u0117s<\/strong> (l\u0105stelinis imunitetas). T l\u0105stel\u0117s, kurios skirstomos \u012f dvi funkcines populiacijas, vis\u0173 pirma yra svarbios visoms imunini\u0173 l\u0105steli\u0173 terapijoms:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>CD8+ citotoksin\u0117s T l\u0105stel\u0117s (CTL)<\/strong><br>per T l\u0105steli\u0173 receptori\u0173 (TCR) atpa\u017e\u012fsta peptid\u0173-MHC I klas\u0117s kompleksus infekuot\u0173 ar piktybini\u0173 l\u0105steli\u0173 pavir\u0161iuje ir sukelia j\u0173 apoptoz\u0119 perforino\/granzimo B i\u0161siskyrim\u0105 arba FasL\/Fas s\u0105veik\u0105.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>CD4+ T l\u0105stel\u0117s pagalbinink\u0117s<\/strong><br>Koordinuoja imunin\u012f atsak\u0105 per citokin\u0173 (IL-2, IFN-\u03b3, TNF-\u03b1) sekrecij\u0105 ir yra b\u016btini ilgalaikiam CTL atsako i\u0161silaikymui.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Mokslinis pagrindas:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pagrindiniai T l\u0105steli\u0173 imunologijos darbai: <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>T l\u0105steli\u0173 i\u0161sekimo v\u0117\u017eio atveju ap\u017evalga: <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>Pagrindinis navik\u0173 imunologijos principas<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">V\u0117\u017eys vystosi ne imunologiniame vakuume. . <strong>V\u0117\u017eio imunoeditavimas<\/strong>-(Dunn, Bruce ir Schreiber, 2004) apra\u0161omi trys etapai:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Pa\u0161alinimas<\/strong><br>Imunin\u0117 sistema atpa\u017e\u012fsta ir sunaikina transformuotas l\u0105steles, naudodama su naviku susijusius antigenus (TAA) ir navikui b\u016bdingus antigenus (TSA). MHC-I tarpininkaujamas mutavusi\u0173 peptid\u0173 pateikimas aktyvuoja CTL.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Pusiausvyra<\/strong><br>Imunin\u0117 sistema palaiko naviko augimo pusiausvyr\u0105, ta\u010diau kartu atrenka imuninei sistemai atsparius variantus.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Pab\u0117gimas<\/strong><br>V\u0117\u017ein\u0117s l\u0105stel\u0117s i\u0161vengia imunin\u0117s kontrol\u0117s ta\u0161k\u0173 (PD-L1, CTLA-4 ligand\u0173), imunosupresini\u0173 citokin\u0173 (TGF-\u03b2, IL-10) sekrecijos ir reguliuojan\u010di\u0173j\u0173 T l\u0105steli\u0173 (Tregs) \u012fdarbinimo.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Mokslinis pagrindas:<\/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, Imunitetas 2013 - V\u0117\u017eio imuniteto ciklas<\/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 l\u0105steli\u0173 terapija - dizainas ir mechanizmas<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 molekulin\u0117 strukt\u016bra<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Chimerinis antigeno receptorius (CAR) yra sintetinis transmembraninis baltymas su keturiais funkciniais domenais:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. ekstral\u0105stelinio suri\u0161imo domenas<\/strong><br>Da\u017eniausiai a <strong>scFv<\/strong> (vienos grandin\u0117s kintamasis fragmentas) monokloninio antik\u016bno. Tiesiogiai jungiasi prie pavir\u0161iaus antigeno (pvz., B l\u0105steli\u0173 CD19, plazmini\u0173 l\u0105steli\u0173 BCMA) nepriklausomai nuo MHC. \u0160is nepriklausomumas nuo MHC yra esminis skirtumas nuo nat\u016bralaus TCR.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. \u0161arnyro ir jungties sritis<\/strong><br>Lankstus tarpas tarp suri\u0161imo srities ir l\u0105stel\u0117s membranos (pvz., IgG4-Hinge, CD8\u03b1-Hinge). Ilgis ir lankstumas turi didel\u0119 \u012ftak\u0105 suri\u0161imo efektyvumui.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. transmembraninis domenas<\/strong><br>\u012etvirtina CAR T l\u0105stel\u0117s membranoje; daro \u012ftak\u0105 signalo stabilumui.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>4. vidul\u0105stelinio signalizavimo domenas<\/strong><br>Sudarytas i\u0161 pirminio aktyvacijos domeno (CD3\u03b6 su 3 ITAM) + ko-stimuliuojan\u010di\u0173 domen\u0173. Ko-stimuliuojantys domenai apibr\u0117\u017eia <strong>CAR generavimas:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Generation<\/th><th>Bendra stimuliacija<\/th><th>Funkcija<\/th><\/tr><\/thead><tbody><tr><td>1 karta<\/td><td>Tik CD3\u03b6<\/td><td>Trumpalaikis, silpnas plitimas<\/td><\/tr><tr><td>2 kartos<\/td><td>CD28 <strong>arba<\/strong> 4-1BB (CD137) + CD3\u03b6<\/td><td>Standartinis \u0161iandien; \"Kymriah\" = 4-1BB; \"Yescarta\" = CD28<\/td><\/tr><tr><td>3 kartos<\/td><td>CD28 <strong>ir<\/strong> 4-1BB + CD3\u03b6<\/td><td>Stipresnis suaktyv\u0117jimas, didesn\u0117 KRS rizika<\/td><\/tr><tr><td>4 kartos<\/td><td>2-asis genas + transgenas (pvz., IL-12, IL-15)<\/td><td>\u201e\u0161arvuotoji CAR\u201c, pager\u0117jusi naviko mikroaplinka<\/td><\/tr><tr><td>5-oji karta<\/td><td>2-asis genas + vidul\u0105stelinis IL-2R\u03b2 domenas<\/td><td>Jagged-CAR; JAK-STAT signalinis kelias<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>4-1BB ir CD28 ko-stimuliacija<\/strong><br>4-1BB-CAR (Kymriah) pasi\u017eymi geresniu ilgalaikiu patvarumu ir ma\u017eesniu i\u0161sekimu (ma\u017eesnis T l\u0105steli\u0173 i\u0161sekimas), CD28-CAR (Yescarta) pasi\u017eymi greitesne pradine aktyvacija ir didesniu ankstyvuoju atsaku, ta\u010diau atsako trukm\u0117 yra trumpesn\u0117.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Mokslinis pagrindas:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Statybos ap\u017evalga 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 ir CD28 palyginimas: <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>Gamybos procesas (autologas)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Leukaferez\u0117<\/strong><br>Vienal\u0105s\u010di\u0173 kraujo l\u0105steli\u0173 surinkimas i\u0161 paciento kraujo atskiriant l\u0105steles per 3-5 valandas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>T l\u0105steli\u0173 aktyvavimas<\/strong><br>Ex vivo stimuliavimas anti-CD3\/anti-CD28 antik\u016bnais dengtomis rutuliukais arba rekombinantiniais ligandais; proliferacij\u0105 skatinantys IL-2 ir IL-7\/IL-15.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Gen\u0173 perdavimas<\/strong><br>CAR geno \u012fvedimas naudojant:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Lentivirusinis vektorius<\/strong> (Kymriah, Breyanzi): Stabili integracija \u012f \u0161eimininko genom\u0105; ilgalaik\u0117 rai\u0161ka<\/li>\n\n\n\n<li><strong>Gammaretrovirusinis vektorius<\/strong> (Yescarta, Tecartus): Pana\u0161us, bet didesn\u0117 \u012fterptin\u0117s mutagenez\u0117s rizika<\/li>\n\n\n\n<li><strong>Transpozon\u0173 sistemos \/ mRNA<\/strong> (eksperimentinis): Neintegruojan\u010dios alternatyvos<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Pl\u0117tra<\/strong><br>Transdukuot\u0173 l\u0105steli\u0173 dauginimasis per 7-14 dien\u0173, paprastai iki 10\u2078-10\u2079 l\u0105steli\u0173.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Kokyb\u0117s kontrol\u0117<\/strong><br>CAR transdukcijos efektyvumo, sterilumo, likutini\u0173 komponent\u0173, T l\u0105steli\u0173 fenotipo, stiprumo tyrimas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Kriokonservavimas ir transportavimas<\/strong><br>\u012f gydymo centr\u0105.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Limfodestrukcija<\/strong><br>Likus 2-7 dienoms iki CAR-T infuzijos, pacientui skiriama chemoterapija (paprastai fludarabinas + ciklofosfamidas), kad suma\u017e\u0117t\u0173 organizmo imunini\u0173 l\u0105steli\u0173 ir atsirast\u0173 \u201eerdv\u0117s\u201c (limfodepelentinis kondicionavimas). \u0160is etapas labai padidina CAR-T l\u0105steli\u0173 proliferacij\u0105 ir patvarum\u0105 d\u0117l homeostatinio IL-7\/IL-15 signalizavimo.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Infuzija<\/strong><br>Vienkartin\u0117 CAR-T l\u0105steli\u0173 infuzija \u012f ven\u0105.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Mokslo pagrindai:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Limfodestrukcijos mechanizmas: <a href=\"https:\/\/www.nature.com\/articles\/nm1263\" target=\"_blank\" rel=\"noopener\">Gattinoni ir kiti, Nature Medicine, 2005 m.<\/a><\/li>\n\n\n\n<li>Gamybos ap\u017evalga: <a href=\"https:\/\/www.cell.com\/molecular-therapy-family\/molecular-therapy\/fulltext\/S1525-0016(16)45462-1\" target=\"_blank\" rel=\"noopener\">Levine ir kt., Molekulin\u0117 terapija, 2017 m.<\/a><\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Wirkmechanismus_Effektorphase\"><\/span>Veikimo mechanizmas ir efektoriaus faz\u0117<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Po infuzijos CAR-T l\u0105stel\u0117s atpa\u017e\u012fsta tikslin\u012f antigen\u0105 naviko l\u0105stel\u0117se, tod\u0117l susidaro imunologin\u0117 sinaps\u0117: CAR prisijungia antigen\u0105 \u2192 CD3\u03b6-ITAM fosforilinamas \u2192 ZAP-70\/Lck kinaz\u0117s kaskada \u2192 NF-\u03baB, NFAT, AP-1 aktyvacija \u2192 perforino\/granzimo B i\u0161siskyrimas (tiesiogin\u0117 citoliz\u0117) + IFN-\u03b3, TNF-\u03b1 (citokin\u0173 sekrecija).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Lygiagre\u010diai: <strong>Aplinkini\u0173 aktyvinimas<\/strong> - i\u0161siskiriantys citokinai suaktyvina kitas endogenines imunines l\u0105steles ir gali sukelti citokin\u0173 i\u0161siskyrimo sindrom\u0105 (CRS).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Mokslas:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>CAR-T veikimo mechanizmas: <a href=\"https:\/\/www.science.org\/doi\/10.1126\/science.aam8871\" target=\"_blank\" rel=\"noopener\">Lim &amp; June, Mokslas 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 l\u0105steli\u0173 terapija: pagrindiniai skirtumai<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>Kod\u0117l TCR, o ne CAR vidul\u0105steliniams antigenams?<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">CAR receptoriai atpa\u017e\u012fsta tik <strong>Pavir\u0161iaus baltymai<\/strong>. Ta\u010diau kadangi dauguma navikui b\u016bding\u0173 antigen\u0173 yra lokalizuoti vidul\u0105steliniu b\u016bdu (transkripcijos veiksniai, med\u017eiag\u0173 apykaitos fermentai, v\u0117\u017eio s\u0117klid\u017ei\u0173 antigenai, pvz., PRAME, MAGE-A4), CAR-T \u0161i\u0173 taikini\u0173 nepasteb\u0117t\u0173.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nat\u016bralus TCR geba atpa\u017einti vidul\u0105stelinius baltymus, nes l\u0105steli\u0173 baltymus nuolat atpa\u017e\u012fsta <strong>Proteasoma<\/strong> suskaidomi \u012f ~8-11 aminor\u016bg\u0161\u010di\u0173 ilgio peptidus. \u0160ie peptidai endoplazminiame tinkle skaidomi \u012f <strong>MHC I klas\u0117s molekul\u0117s (\u017emoni\u0173 HLA)<\/strong> ir perne\u0161amas \u012f l\u0105stel\u0117s pavir\u0161i\u0173. Ten juos suri\u0161a \u03b1\u03b2-TCR - \u0161is mechanizmas veikia visose branduolio l\u0105stel\u0117se.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Techninis TCR terapijos i\u0161\u0161\u016bkis<\/strong> yra b\u016btinas HLA apribojimas: nat\u016bralus didelio afiniteto TCR atpa\u017e\u012fsta konkret\u0173 peptid\u0105 tik esant konkre\u010diam HLA aleliui (pvz., HLA-A*02:01, kuris pasitaiko ma\u017edaug 40-50 % Kaukazo gyventoj\u0173). Tai rei\u0161kia, kad pacientai turi b\u016bti ir HLA suderinami, ir teigiami tikslinio antigeno at\u017evilgiu.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Struktur_des_therapeutischen_TCR\"><\/span>Terapinio TCR strukt\u016bra<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Terapiniai TCR da\u017eniausiai yra <strong>\u03b1\u03b2-TCR heterodimerai<\/strong>, kuris:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Sukurtas naudojant fag\u0173 ekran\u0105 arba peli\u0173 humanizacij\u0105, pasi\u017eymi itin dideliu giminingumu (KD pM diapazone). Nat\u016bralus TCR turi tik vidutin\u012f giminingum\u0105 (\u03bcM), nes per didelis giminingumas sukelt\u0173 autoimunitet\u0105<\/li>\n\n\n\n<li>Stabilizuota nuo nety\u010dinio suporavimo su endogenin\u0117mis TCR grandin\u0117mis d\u0117l murin\u0173 pakaital\u0173 arba disulfidini\u0173 tilteli\u0173<\/li>\n\n\n\n<li>\u012fvesti \u012f paciento T l\u0105steles, naudojant lentivirusin\u0119 transdukcij\u0105.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Mokslas:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>TCR afiniteto in\u017einerija: <a href=\"https:\/\/www.jimmunol.org\/content\/180\/9\/6116\" target=\"_blank\" rel=\"noopener\">Robbins ir kt., Journal of Immunology, 2008 m.<\/a><\/li>\n\n\n\n<li>TCR-T mechanizmo ap\u017evalga: <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 baz\u0117 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 - nat\u016bralaus naviko aptikimo principas<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>Biologinis pagrindas<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">\u012e navikus infiltruojasi imunin\u0117s l\u0105stel\u0117s. <strong>navik\u0105 infiltruojantys limfocitai (TIL)<\/strong>. \u0160ios T l\u0105stel\u0117s jau atpa\u017e\u012fsta navik\u0105, ta\u010diau d\u0117l imunosupresyvios naviko mikroaplinkos (TME) jos da\u017enai b\u016bna i\u0161sekusios, alergi\u0161kos arba j\u0173 b\u016bna per ma\u017eai. Didelis TIL tankis navike susij\u0119s su geresne daugelio v\u0117\u017eio r\u016b\u0161i\u0173 prognoze.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">TIL terapijos id\u0117ja (sukurta Steveno Rosenbergo (Steven Rosenberg) NCI, Betesda, 1980-aisiais): TIL (angl. TIL) - tai naujausia T limfocit\u0173 technologija, kuri\u0105 suk\u016br\u0117 mokslininkas, dirbantis su T limfocitais, sukurtas iki tol, kol buvo prad\u0117tas taikyti senas metodas (angl. TIL).<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Herstellungsprozess_Lifileucel\"><\/span>Gamybos procesas (Lifileucel)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Naviko i\u0161pjovimas<\/strong><br>Chirurginiu b\u016bdu pa\u0161alinama ne ma\u017eiau kaip 1,5 cm\u00b3 naviko audinio ir nedelsiant perdirbama \u012f <a href=\"https:\/\/www.iovance.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">Iovance Biotherapeutics, Inc.<\/a> i\u0161si\u0173stas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Pradin\u0117 pl\u0117tra (ma\u017edaug 11 dien\u0173)<\/strong><br>V\u0117\u017eys mechani\u0161kai ir fermentiniu b\u016bdu atskiriamas; TIL kultivuojami naudojant IL-2 \u2192 Pre-REP (Pre-Rapid Expansion Protocol).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Greita pl\u0117tra (ma\u017edaug 11 dien\u0173)<\/strong><br>TIL apdorojamos anti-CD3 antik\u016bnais (OKT3), ap\u0161vitintomis alogenin\u0117mis PBMC (kurios veikia kaip antigen\u0105 pateikian\u010dios l\u0105stel\u0117s) ir IL-2. <strong>&gt;7,5 \u00d7 10\u2079 l\u0105steli\u0173<\/strong> ple\u010diasi (nuo keli\u0173 milijon\u0173 iki milijard\u0173).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Limfodestrukcija ir infuzija<\/strong><br>Pana\u0161iai kaip ir CAR-T: Flu\/Cy kondicionavimas, tada vienkartin\u0117 TIL infuzija, po to IL-2 vartojimas tolesniam in vivo i\u0161plitimui.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Laikotarpis<\/strong><br>Gamybos trukm\u0117 apie 22 dienos; i\u0161 viso nuo naviko pa\u0161alinimo iki infuzijos praeina apie 6-7 savait\u0117s.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Mokslas:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Rosenbergo novatori\u0161kas darbas: <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJM198812223192529\" target=\"_blank\" rel=\"noopener\">Rosenbergas ir kiti, NEJM, 1988 m.<\/a><\/li>\n\n\n\n<li>Lifileucel 2 faz\u0117s pagrindinis tyrimas (C-144-01): <a href=\"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.21.02179\" target=\"_blank\" rel=\"noopener\">Chesney ir kt., JCO 2022<\/a><\/li>\n\n\n\n<li>5 met\u0173 steb\u0117jimas: <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/40699950\/\" target=\"_blank\" rel=\"noopener\">PubMed FDA patvirtinimo santrauka 2024 m.<\/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>I\u0161\u0161\u016bkiai - dabartiniai mokslini\u0173 tyrim\u0173 metodai<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>Antigeno pab\u0117gimas<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Problemos apibr\u0117\u017eimas<\/strong><br>V\u0117\u017eio l\u0105stel\u0117s gali suma\u017einti tikslinio antigeno rai\u0161k\u0105 arba jos netekti. CD19-CAR-T atveju CD19 neigiamas recidyvas pasirei\u0161kia 30-40 % atvej\u0173.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Sprendimas<\/strong><br>Dvigubo nukreipimo strategijos (CD19+CD22, BCMA+CD38), tandeminiai CAR, loginiai vartai CAR (AND vartai: reikia dviej\u0173 antigen\u0173; NOT vartai: \u017eudo tik l\u0105steles be apsauginio antigeno).<\/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 l\u0105steli\u0173 i\u0161sekimas (i\u0161sekimas)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Problemos apibr\u0117\u017eimas<\/strong><br>V\u0117\u017eio l\u0105stel\u0117s gali suma\u017einti tikslinio antigeno rai\u0161k\u0105 arba jos netekti. CD19-CAR-T atveju CD19 neigiamas recidyvas pasirei\u0161kia 30-40 % atvej\u0173.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">L\u0117tinis antigen\u0173 poveikis \u2192 I\u0161sekimo \u017eymen\u0173 (PD-1, TIM-3, LAG-3, TOX transkripcijos faktorius) rai\u0161ka \u2192 Funkcijos praradimas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Sprendimas:<\/strong> Derinys su kontrolini\u0173 ta\u0161k\u0173 inhibitoriais, epigenetinis perprogramavimas nukabinant TET2, naujos kartos CAR konstrukcijos su integruota kontrolini\u0173 ta\u0161k\u0173 blokada.<\/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 nukabinimas)<\/a><\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tumormikroumgebung_TME\"><\/span>V\u0117\u017eio mikroaplinka (TME)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Problemos apibr\u0117\u017eimas<\/strong><br>V\u0117\u017eio l\u0105stel\u0117s gali suma\u017einti tikslinio antigeno rai\u0161k\u0105 arba jos netekti. CD19-CAR-T atveju CD19 neigiamas recidyvas pasirei\u0161kia 30-40 % atvej\u0173.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Solidini\u0173 navik\u0173 mikroaplinka yra prie\u0161i\u0161ka: hipoksija, gliukoz\u0117s tr\u016bkumas, imunosupresiniai citokinai (TGF-\u03b2, IL-10), Tregs, MDSC.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Sprendimas<\/strong><br>\u0160arvuoti CAR su IL-12\/IL-15\/IL-18 sekrecija, PD-1 atspar\u016bs CAR, derinys su anti-VEGF, vietin\u0117s intratumoralin\u0117s injekcijos.<\/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 ir kt., 2017 m. \"Scientific Reports\" (\u0161arvuotasis automobilis)<\/a><\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Zytokinsturm_CRS_ICANS\"><\/span>Citokin\u0173 audra (CRS) ir ICANS<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Problemos apibr\u0117\u017eimas<\/strong><br>CRS sukelia masinis citokin\u0173 (IL-6, IFN-\u03b3, IL-1\u03b2) i\u0161siskyrimas i\u0161 aktyvuot\u0173 CAR-T ir makrofag\u0173. Sunkus CRS (3-4 laipsnio) reikalauja intensyvaus gydymo. ICANS (neurologinis toksi\u0161kumas) atsiranda d\u0117l endotelio aktyvacijos ir kraujo-smegen\u0173 barjero disfunkcijos.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Valdymas<\/strong><br>Tocilizumabas (IL-6R blokada), kortikosteroidai, anakinra (IL-1 blokada); ankstyva intervencija pagerina rezultatus.<\/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 ir kt., Kraujas 2014 - CRS klasifikavimo sistema<\/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>Alogeniniai \u201egatavi\u201c gydymo b\u016bdai<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Problemos apibr\u0117\u017eimas<\/strong><br>V\u0117\u017eio l\u0105stel\u0117s gali suma\u017einti tikslinio antigeno rai\u0161k\u0105 arba jos netekti. CD19-CAR-T atveju CD19 neigiamas recidyvas pasirei\u0161kia 30-40 % atvej\u0173.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Autologin\u0117s med\u017eiagos gamyba trunka 3-6 savaites ir yra brangi (400 000-600 000 eur\u0173).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Sprendimas<\/strong><br>Alogenin\u0117 CAR-T i\u0161 sveik\u0173 donor\u0173, su CRISPR endogeninio TCR (GvHD prevencija) ir HLA komponent\u0173 (atmetimo prevencija) nukabinimu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Dabartiniai duomenys<\/strong><br>CTX112 (CRISPR-allogenic CD19-CAR-T) rodo pirm\u0105sias CLL visi\u0161kas remisijas 1 faz\u0117s metu.<\/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 ir kt., \"Science 2020\" - CRISPR CAR-T 1 etapas<\/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 Kiekybiniai efektyvumo duomenys i\u0161 pirmo \u017evilgsnio<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>Indikacija<\/th><th>ORR<\/th><th>CR norma<\/th><th>OS mediana<\/th><th>\u0160altinis<\/th><\/tr><\/thead><tbody><tr><td>Tisagenlecleucel<\/td><td>B-ALL pediatrinis<\/td><td>81 %<\/td><td>60 %<\/td><td>NR (63 % per 12 m\u0117n.)<\/td><td>NEJM 2018<\/td><\/tr><tr><td>Axicabtagene-cel<\/td><td>DLBCL 3-ioji linija<\/td><td>83 %<\/td><td>58 %<\/td><td>NR (74 % per 12 m\u0117n.)<\/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 % per 12 m\u0117n.)<\/td><td>Lancet 2021<\/td><\/tr><tr><td>Lifileucel<\/td><td>Melanoma<\/td><td>31,4 %<\/td><td>7,5 %<\/td><td>NR (49 % per 24 m\u0117n.)<\/td><td>JCO 2022<\/td><\/tr><tr><td>Afamitresgene-cel<\/td><td>Sinovijos sarkoma<\/td><td>43 %<\/td><td>4 %<\/td><td>16,4 m\u0117nesio<\/td><td>Lancet 2024<\/td><\/tr><tr><td>Tebentafusp<\/td><td>Uvealin\u0117 melanoma<\/td><td>9 % (ORR)<\/td><td>&lt;1 %<\/td><td>21,7 m\u0117nesio<\/td><td>NEJM 2021<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><em>(NR = nepasiektas; OS* dar nepasiektas)<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">*<em>OS<\/em> (<em>Bendras i\u0161gyvenamumas<\/em>\u00a0) - pvz., \u201e<em>OS mediana 21,7<\/em>\u201e pus\u0117 pacient\u0173 mir\u0117 po 21,7 m\u0117nesio, o kita pus\u0117 tebebuvo gyvi.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Weiterfuhrende_Literatur_Ressourcen\"><\/span>Papildoma literat\u016bra ir i\u0161tekliai<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Atsiliepimai:<\/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 terapijos ap\u017evalga<\/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 terapijos ap\u017evalga<\/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 - Alogeninis TCR\/CAR-T<\/a><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Gair\u0117s ir duomen\u0173 baz\u0117s:<\/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 vykstantys imunini\u0173 l\u0105steli\u0173 terapijos tyrimai<\/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 - Imunoterapijos ap\u017evalga<\/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\">Vokietijos hematolog\u0173 draugija (DGHO) - CAR-T terapija<\/a><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Pacientams skirti i\u0161tekliai (vokie\u010di\u0173 kalba):<\/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 - Imunoterapija paai\u0161kinta<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.kitz-heidelberg.de\/forschungsprogramme\/zell-und-gentherapie\/\" target=\"_blank\" rel=\"noopener\">KiTZ Heidelbergas - Pacientai ir imunoterapija<\/a><\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Per ma\u017eiau nei de\u0161imtmet\u012f imunini\u0173 l\u0105steli\u0173 terapija i\u0161 eksperimentin\u0117s koncepcijos tapo standartine klinikine terapija, o patvirtint\u0173 produkt\u0173 ir indikacij\u0173 skai\u010dius spar\u010diai auga. Pacientams, kurie atitinka reikalavimus, tai gali b\u016bti vienintelis galimas gydymo b\u016bdas.<\/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>Visame pasaulyje patvirtintos imunini\u0173 l\u0105steli\u0173 terapijos<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">B\u016bkl\u0117 02.2026<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Einleitung_Die_drei_grosen_Klassen\"><\/span>\u012evadas: Trys pagrindin\u0117s klas\u0117s<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u0160iandien terminas \u201eimunini\u0173 l\u0105steli\u0173 terapija\u201c apima tris skirtingas onkologini\u0173 produkt\u0173 kategorijas:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. CAR-T l\u0105steli\u0173 terapija<\/strong> (chimerini\u0173 antigeno receptori\u0173 T l\u0105stel\u0117s)<br>Geneti\u0161kai modifikuotos T l\u0105stel\u0117s, turin\u010dios sintetin\u012f pavir\u0161iaus receptori\u0173, atpa\u017e\u012fstant\u012f l\u0105steli\u0173 pavir\u0161iuje esan\u010dius naviko antigenus. Visi iki \u0161iol patvirtinti produktai yra nukreipti prie\u0161 CD19 arba BCMA ir juos leid\u017eiama naudoti kraujo v\u0117\u017eiui gydyti.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. TCR-T l\u0105steli\u0173 terapija<\/strong> (T l\u0105steli\u0173 receptori\u0173 T l\u0105stel\u0117s)<br>Geneti\u0161kai modifikuotos T l\u0105stel\u0117s, turin\u010dios optimizuot\u0105 nat\u016bral\u0173 T l\u0105steli\u0173 receptori\u0173, atpa\u017e\u012fstant\u012f vidul\u0105stelinius naviko baltymus, pateikiamus HLA komplekse. Pirm\u0105 kart\u0105 patvirtintas 2024 m. solidiniams navikams gydyti.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3-iasis TIL gydymas<\/strong> (navik\u0105 infiltruojantys limfocitai)<br>Geneti\u0161kai nemodifikuotos T l\u0105stel\u0117s, gautos i\u0161 paciento naviko, masi\u0161kai padaugintos ir pakartotinai suleistos. Pirm\u0105 kart\u0105 patvirtintas melanomai gydyti 2024 m.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2024 m. gruod\u017eio m\u0117n. FDA patvirtino \u0161e\u0161is CAR-T l\u0105steli\u0173 gydymo b\u016bdus, o visame pasaulyje komerciniais tikslais galima \u012fsigyti de\u0161imt CAR-T l\u0105steli\u0173 gydymo b\u016bd\u0173. Be to, yra TIL terapija (\"Lifileucel\") ir TCR terapija (\"Afamitresgene autoleucel\") - pirmosios savo klas\u0117je, skirtos solidiniams navikams gydyti. <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 L\u0104STELI\u0172 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>Tisagenoleukelis (Kymriah\u00ae) - <em>\"Novartis\"<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Tikslinis antigenas:<\/strong> CD19 <br><strong>\u012egaliotas:<\/strong> FDA 2017 \/ EMA 2018<br><strong>Pirmasis CAR-T preparatas, kur\u012f leista naudoti visame pasaulyje<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Indikacijos<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Vaikai ir jauni suaugusieji iki 25 met\u0173: atsinaujinusi ir (arba) atspari B l\u0105steli\u0173 ALL (\u016bmin\u0117 limfoblastin\u0117 leukemija)<\/li>\n\n\n\n<li>Suaugusieji: recidyvavusi ir (arba) refrakterin\u0117 stambi\u0173j\u0173 B l\u0105steli\u0173 limfoma (LBCL) po \u22652 sistemini\u0173 gydymo b\u016bd\u0173<\/li>\n\n\n\n<li>Atsinaujinusi ir (arba) refrakterin\u0117 folikulin\u0117 limfoma (FL)<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Svarbiausi tyrimai<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ELIANA tyrimas (ALL pediatrinis): <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 tyrimas (LBCL): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT02445248\" target=\"_blank\" rel=\"noopener\">NCT02445248<\/a><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Leidimus i\u0161duodan\u010dios institucijos<\/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 (Australija)<\/li>\n\n\n\n<li>PMDA (Japonija) <\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Gamintojas ir (arba) interneto svetain\u0117:<\/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 class=\"wp-block-paragraph\"><strong>FDA produkto puslapis:<\/strong> <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/kymriah\" target=\"_blank\" rel=\"noopener\">Maisto ir vaist\u0173 administracija (FDA) Kymriah<\/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>Aksikabtageno ciloleucelis (Yescarta\u00ae) - <em>\"Kite\/Gilead<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Tikslinis antigenas:<\/strong> CD19<br><strong>\u012egaliotas:<\/strong> FDA 2017 m. spalio m\u0117n. \/ EMA 2018 m. rugpj\u016b\u010dio m\u0117n.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Indikacijos<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Dideli\u0173 B l\u0105steli\u0173 limfoma (DLBCL, PMBCL, HGBCL, tFL) po \u22652 sistemini\u0173 gydymo b\u016bd\u0173<\/li>\n\n\n\n<li>Pirminis atsparus DLBCL arba atkrytis per 12 m\u0117nesi\u0173 (antroji linija)<\/li>\n\n\n\n<li>Atsinaujinusi ir (arba) refrakterin\u0117 folikulin\u0117 limfoma po \u22652 sistemini\u0173 gydymo metod\u0173<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Svarbiausi tyrimai<\/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 (antros eil\u0117s prie\u0161 ASCT): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03391466\" target=\"_blank\" rel=\"noopener\">NCT03391466<\/a><\/li>\n\n\n\n<li>ZUMA-5 (folikulin\u0117 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 class=\"wp-block-paragraph\"><strong>Gydymo centrai (D\/A\/CH atranka)<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Visi kvalifikuoti FACT\/JACIE akredituoti transplantacijos centrai; Vokietijoje, pavyzd\u017eiui, Hamburgo-Eppendorfo universiteto medicinos centras, Berlyno \"Charit\u00e9\", Miuncheno LSMU klinikos, Heidelbergo universiteto medicinos centras.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Gamintojas \/ interneto svetain\u0117<\/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 class=\"wp-block-paragraph\"><strong>Tikslinis antigenas:<\/strong> CD19<br><strong>\u012egaliotas:<\/strong> FDA 2020 m. liepa (MCL), 2021 m. spalis (visi suaugusieji) \/ EMA 2020 m. gruodis<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Indikacijos<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Atsinaujinusi ir (arba) refrakterin\u0117 mantijos l\u0105steli\u0173 limfoma (MCL) po BTK inhibitoriaus vartojimo<\/li>\n\n\n\n<li>Suaugusieji, sergantys recidyvuojan\u010dia ir (arba) atsparia B l\u0105steli\u0173 ALL<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Svarbiausi tyrimai<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ZUMA-2 (MCL, OS 12 m\u0117n.: 83 %): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT02601313\" target=\"_blank\" rel=\"noopener\">NCT02601313<\/a><\/li>\n\n\n\n<li>ZUMA-3 (suaugusi\u0173j\u0173 B-ALL, OS mediana 18,2 m\u0117n.): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT02614066\" target=\"_blank\" rel=\"noopener\">NCT02614066<\/a><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA produkto puslapis:<\/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>Lisocabtagenas Maraleucel (Breyanzi\u00ae) - <em>\"Bristol Myers Squibb<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Tikslinis antigenas:<\/strong> CD19<br><strong>\u012egaliotas:<\/strong> FDA 2021 m. vasaris (pradinis) \/ i\u0161pl\u0117stin\u0117s indikacijos 2022-2024 m. \/ EMA 2022 m. spalis<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Indikacijos<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Stambi\u0173j\u0173 B l\u0105steli\u0173 limfoma (LBCL, DLBCL, HGBCL, FL) 2 + 3 eil\u0117s<\/li>\n\n\n\n<li>L\u0117tin\u0117 limfocitin\u0117 leukemija (CLL) \/ smulkial\u0105stelin\u0117 limfocitin\u0117 limfoma (SLL) po \u22652 gydymo b\u016bd\u0173, \u012fskaitant BTK inhibitori\u0173 (FDA 2024)<\/li>\n\n\n\n<li>Folikulin\u0117 limfoma (FL) po \u22652 sistemini\u0173 gydymo b\u016bd\u0173<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Svarbiausi tyrimai<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>TRANSFORM (2-osios eil\u0117s 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 class=\"wp-block-paragraph\"><strong>FDA produkto puslapis:<\/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 class=\"wp-block-paragraph\"><strong>Tikslinis antigenas:<\/strong> BCMA (B l\u0105steli\u0173 brendimo antigenas)<br><strong>\u012egaliotas:<\/strong> FDA 2021 m. kovas \/ EMA 2021 m. rugpj\u016btis<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Indikacija<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Atsinaujinusi ir (arba) atspari daugybin\u0117 mieloma po \u2265 4 ankstesni\u0173 gydymo linij\u0173<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Svarbiausias tyrimas<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>KarMMa tyrimas (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 class=\"wp-block-paragraph\"><strong>FDA produkto puslapis:<\/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 class=\"wp-block-paragraph\"><strong>Tikslinis antigenas:<\/strong> BCMA (dvigubo suri\u0161imo)<br><strong>\u012egaliotas:<\/strong> FDA 2022 m. vasario m\u0117n. (\u22654 linijos), prat\u0119sta 2024 m. baland\u017eio m\u0117n. (\u22651 linija) \/ EMA 2022 m. gegu\u017e\u0117s m\u0117n.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Speciali funkcija:<\/strong> Unikalus dviej\u0173 antik\u016bn\u0173 CAR su dviem BCMA jungian\u010diais vieno domeno antik\u016bnais; laikomas veiksmingiausiu iki \u0161iol patvirtintu mielomos gydymo metodu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Indikacijos<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Atsinaujinusi ir (arba) l\u016b\u017eusi daugybin\u0117 mieloma po \u2265 4 gydymo linij\u0173<\/li>\n\n\n\n<li>Nuo 2024 m. baland\u017eio m\u0117n. (FDA): po \u2265 1 gydymo linijos, kai liga atspari lenalidomidui.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Svarbiausi tyrimai<\/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 etapas, 1-ojo atkry\u010dio prat\u0119simas): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04181827\" target=\"_blank\" rel=\"noopener\">NCT04181827<\/a><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA produkto puslapis:<\/strong> <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/carvykti\" target=\"_blank\" rel=\"noopener\">Maisto ir vaist\u0173 administracija Carvykti<\/a><br><strong>Gamintojas:<\/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>(nauja: 11.2024)<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Tikslinis antigenas:<\/strong> CD19 (greito i\u0161jungimo konstrukcija - ma\u017eesnis toksi\u0161kumas nei pirmtako)<br><strong>\u012egaliotas:<\/strong> FDA 2024 m. lapkri\u010dio 8 d.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Indikacija<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Suaugusieji, sergantys recidyvuojan\u010dia ir (arba) atsparia B l\u0105steli\u0173 ALL<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Speciali funkcija:<\/strong> Pirmasis CAR-T preparatas, patvirtintas be REMS (Rizikos vertinimo ir ma\u017einimo strategijos) programos; tai rodo didesn\u012f saugum\u0105 ir nauj\u0105 CD19 suri\u0161imo koncepcij\u0105.<br><a href=\"https:\/\/www.dasgelbeblatt.de\/welt\/immunzelltherapie-heilt-ueberraschend-krebs-bei-einem-jugendlichen-zr-94168662.html\" target=\"_blank\" rel=\"noreferrer noopener\">Geltonas lapas<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Svarbiausias tyrimas<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FELIX tyrimas (1\/2 faz\u0117, CR rodiklis 42 % per 3 m\u0117nesius): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04404660\" target=\"_blank\" rel=\"noopener\">NCT04404660<\/a><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA produkto puslapis:<\/strong> <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/aucatzyl\" target=\"_blank\" rel=\"noopener\">FDA Aucatzyl<\/a><br><strong>Gamintojas:<\/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>Leid\u017eiama visame pasaulyje - NE JAV\/ES (kitose \u0161alyse)<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>Kinija (NMPA) - keturi papildomi CAR-T produktai<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">I\u0161 viso pasaulyje pradinis patvirtinimas suteiktas vienuolikai autologini\u0173 CAR-T l\u0105steli\u0173 terapij\u0173. Septynis i\u0161 j\u0173 patvirtino FDA ir keturis - Kinijos NMPA, visi jie skirti gydyti recidyvavusiems ir (arba) refrakteriniams hematologiniams piktybiniams navikams.<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>Prekybos pavadinimas<\/th><th>Veiklioji med\u017eiaga<\/th><th>Tikslinis antigenas<\/th><th>Indikacija<\/th><th>Leidimas<\/th><\/tr><\/thead><tbody><tr><td>Carteyva<\/td><td>Relmacabtagene autoleucel<\/td><td>BCMA<\/td><td>Mult. Mieloma, DLBCL<\/td><td>NMPA 2021\/2023 M.<\/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 l\u0105steli\u0173 limfoma<\/td><td>NMPA<\/td><\/tr><tr><td>Zever-cel<\/td><td>\u2014<\/td><td>CD19\/BCMA<\/td><td>Haematolog.<\/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 class=\"wp-block-paragraph\"><strong>NexCAR19<\/strong> (Actalycabtagene autoleucel) buvo patvirtintas 2023 m. spalio m\u0117n. kaip pirmoji CAR-T terapija, sukurta Indijoje. \u0160i terapija, kuri\u0105 suk\u016br\u0117 \"ImmunoACT\" IIT Bomb\u0117juje, kainuoja apie 50 000 JAV doleri\u0173 - ma\u017edaug de\u0161imtadal\u012f pana\u0161i\u0173 vakarieti\u0161k\u0173 produkt\u0173. <a href=\"https:\/\/www.dasgelbeblatt.de\/welt\/immunzelltherapie-heilt-ueberraschend-krebs-bei-einem-jugendlichen-zr-94168662.html\" target=\"_blank\" rel=\"noreferrer noopener\">Geltonas lapas<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Indikacija<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Atsinaujinusi ir (arba) atspari B l\u0105steli\u0173 ne Hod\u017ekino limfoma ir B l\u0105steli\u0173 ALL<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Gydymo centras:<\/strong> Tata memorialin\u0117 ligonin\u0117, Mumbajus <br><strong>Gamintojas:<\/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 L\u0105steli\u0173 terapija (leid\u017eiama)<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>Afamitresgenas Autoleucel (Tecelra\u00ae) - <em>Adaptimmune<\/em> <em>(2024 m. rugpj\u016b\u010dio m\u0117n.)<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">2024 m. rugpj\u016b\u010dio 2 d. FDA patvirtino \"Afamitresgene autoleucel\" (\"Afami-cel\", \"Tecelra\") kaip pirm\u0105j\u0105 TCR T l\u0105steli\u0173 terapij\u0105 v\u0117\u017eiui gydyti ir ypa\u010d kaip pirm\u0105j\u012f geneti\u0161kai modifikuot\u0105 T l\u0105steli\u0173 preparat\u0105, skirt\u0105 solidiniam navikui gydyti. <a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC12283372\/\" target=\"_blank\" rel=\"noreferrer noopener\">PubMed Central<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Tikslinis antigenas:<\/strong> MAGE-A4 (vidul\u0105stelinio v\u0117\u017eio s\u0117klid\u017ei\u0173 antigenas), kur\u012f pateikia HLA-A*02:01<br><strong>\u012egaliotas:<\/strong> FDA 2024 m. rugpj\u016b\u010dio m\u0117n.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Indikacija<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Suaugusieji, sergantys neoperuotinu arba metastazavusiu v\u0117\u017eiu <strong>Sinovijos sarkoma<\/strong> (mink\u0161t\u0173j\u0173 audini\u0173 sarkoma), i\u0161 anksto gydyta chemoterapija, MAGE-A4 teigiamas ir HLA-A*02:01 teigiamas<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Pagrindiniame 2 faz\u0117s SPEARHEAD-1 tyrime sinovijos sarkoma sergan\u010di\u0173 pacient\u0173 navik\u0173 atsakas \u012f gydym\u0105 truko vidutini\u0161kai 11,6 m\u0117nesio. Kai kuriems pacientams naviko nebuvo aptikta kelerius metus. <a href=\"https:\/\/www.clinicaltrialvanguard.com\/news\/t-knife-files-for-phase-1-trial-of-prame-t-cell-therapy\/\" target=\"_blank\" rel=\"noreferrer noopener\">Klinikini\u0173 tyrim\u0173 avangardas<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Svarbiausias tyrimas<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>SPEARHEAD-1 (2 etapas): <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 m. balandis<\/a><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Gydymo centras (Pioneer):<\/strong> Memorial Sloan Kettering v\u0117\u017eio centras, Niujorkas - <a href=\"https:\/\/www.mskcc.org\/news\/immunotherapy-clinical-trial-shows-promise-for-treating-rare-sarcomas\" target=\"_blank\" rel=\"noopener\">MSK \"Tecelra\" informacija<\/a><br><strong>FDA produkto puslapis:<\/strong> <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/tecelra\" target=\"_blank\" rel=\"noopener\">FDA Tecelra<\/a> <br><strong>NCI straipsnis:<\/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>Imunocore<\/em> <em>(2022 m. sausio m\u0117n.)<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Tai ne klasikinis l\u0105steli\u0173 produktas (ne infuzinis T l\u0105steli\u0173 produktas), o bispecifinis TCR sintez\u0117s baltymas, ta\u010diau mechani\u0161kai priskiriamas TCR pagr\u012fstos imunoterapijos kategorijai ir da\u017enai aptariamas kaip PRAME-TCER\u00ae technologijos pirmtakas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Mechanizmas:<\/strong> I\u0161 vienos pus\u0117s jungiasi su gp100 peptidu + HLA-A*02:01 ant naviko l\u0105steli\u0173, i\u0161 kitos - su CD3 ant T l\u0105steli\u0173 (ImmTAC technologija).<br><strong>\u012egaliotas:<\/strong> FDA 2022 m. sausis \/ EMA 2022 m. vasaris<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Indikacijos:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>HLA-A*02:01 teigiam\u0105 rezultat\u0105 turintys suaugusieji, sergantys nepagydomu arba metastazavusiu v\u0117\u017eiu <strong>uvealin\u0117 melanoma<\/strong> (aki\u0173 melanoma) - 1-oji linija<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Speciali funkcija:<\/strong> Pirmasis kada nors patvirtintas vaistas uvealinei melanomai gydyti<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3 faz\u0117s IMCgp100-202 tyrime tebentafusp parod\u0117 reik\u0161ming\u0105 i\u0161gyvenamumo prana\u0161um\u0105, palyginti su gydytojo pasirinktais vaistais (pembrolizumabu, ipilimumabu arba dakarbazinu): OS mediana 21,7 vs. 16,0 m\u0117nesio (HR 0,51; p&lt;0,0001). Vieneri\u0173 met\u0173 OS rodiklis buvo 73 % palyginti su 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 class=\"wp-block-paragraph\"><strong>Svarbiausias tyrimas<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>IMCgp100-202 (3 etapas): <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 met\u0173 atnaujinimas NEJM 2023<\/a><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA puslapis:<\/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>Gamintojas:<\/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 (leid\u017eiama)<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 m. vasario m\u0117n.)<\/em><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">2024 m. vasario 16 d. \"Lifileucel\" buvo patvirtintas kaip pirmoji T-l\u0105steli\u0173 terapija solidiniam navikui gydyti ir pirmoji TIL terapija istorijoje. <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 class=\"wp-block-paragraph\"><strong>Mechanizmas:<\/strong> Chirurginiu b\u016bdu pa\u0161alinamas navikas, i\u0161skiriami navik\u0105 infiltruojantys limfocitai (TIL), jie masi\u0161kai dauginami ir po limfodeplikacijos v\u0117l suleid\u017eiami \u012f organizm\u0105. Joki\u0173 genetini\u0173 modifikacij\u0173 - naudojamas nat\u016bralus TIL atpa\u017einimas i\u0161 naviko.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Indikacija<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Suaugusieji, sergantys neoperuotinu arba metastazavusiu v\u0117\u017eiu <strong>Melanoma<\/strong> (odos melanoma) po ankstesnio gydymo anti-PD-1 ir BRAF\/MEK inhibitoriumi (jei BRAF mutacija)<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Atlikus 2 faz\u0117s C-144-01 tyrimo penkeri\u0173 met\u0173 steb\u0117sen\u0105, nustatyta, kad \"Lifileucel\" objektyvus atsakas buvo 31,4 %, o vidutin\u0117 atsako trukm\u0117 - 36,5 m\u0117nesio - su ilgalaikiu atsaku daugiau nei 30 % atsakiusi\u0173 pacient\u0173. <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 class=\"wp-block-paragraph\"><strong>Svarbiausias tyrimas<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>C-144-01 (2 faz\u0117, NCT02360579): <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT02360579\" target=\"_blank\" rel=\"noopener\">Klinikiniai tyrimai<\/a> | <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/40699950\/\" target=\"_blank\" rel=\"noopener\">FDA patvirtinimo santrauka PubMed<\/a><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Gydymo centrai (JAV atranka):<\/strong> Johnso Hopkinso, UCLA, MD Andersono, UCSF, Memorial Sloan Ketteringo, Mayo klinikos<br><strong>NCI straipsnis:<\/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>Gamintojas:<\/strong> <a href=\"https:\/\/www.iovance.com\" target=\"_blank\" rel=\"noopener\">iovance.com<\/a><br><strong>FDA produkto puslapis:<\/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>Vis\u0173 pasaulyje taikom\u0173 imunini\u0173 l\u0105steli\u0173 terapij\u0173 ap\u017evalga<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>Produktas<\/th><th>Veiklioji med\u017eiaga<\/th><th>Tipas<\/th><th>Tikslas<\/th><th>Indikacija<\/th><th>Leidimas<\/th><th>Metai<\/th><\/tr><\/thead><tbody><tr><td><strong>Kymriah<\/strong><\/td><td>Tisagenlecleucel<\/td><td>CAR-T<\/td><td>CD19<\/td><td>B-ALL vaik\u0173, 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, suaugusi\u0173j\u0173 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 eilut\u0117s<\/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 eilut\u0117<\/td><td>FDA, EMA, NMPA<\/td><td>2022<\/td><\/tr><tr><td><strong>Kimmtrak<\/strong><\/td><td>Tebentafusp-tebn<\/td><td>TCR-Bispecifinis<\/td><td>gp100+HLA<\/td><td>Uvealin\u0117 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>Polikloninis<\/td><td>Melanoma (solidinis navikas)<\/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>Sinovijos 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>Suaugusi\u0173j\u0173 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>\u0160alutinis poveikis - kas b\u016bdinga visiems gydymo b\u016bdams<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Svarbiausi bendri pavojai:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Citokin\u0173 audra (CRS)<\/strong><br>Da\u017enai pasitaiko su CAR-T ir TCR-T; retai su TIL.<br>Gydymas tocilizumabu.<br>Nuo 2024 m. visose CAR-T etiket\u0117se: \u012fsp\u0117jimas d\u0117l antrini\u0173 T l\u0105steli\u0173 piktybini\u0173 navik\u0173 (labai retas, ~3,6 % per metus).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>ICANS (neurotoksi\u0161kumas)<\/strong><br>Su imunin\u0117mis l\u0105stel\u0117mis susij\u0119s neurotoksi\u0161kumo sindromas; \u017einomas CAR-T atveju, retesnis TIL atveju.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Citopenijos<\/strong><br>D\u0117l b\u016btinos limfodeplikacijos (chemoterapijos prie\u0161 infuzij\u0105) visada atsiranda trumpalaiki\u0173 kraujo l\u0105steli\u0173 poky\u010di\u0173.<\/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 Vokietijoje si\u016bloma \u0161i terapija?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Visi FDA\/EMA patvirtinti CAR-T produktai gaminami <strong>specializuoti transplantacijos centrai<\/strong> sertifikuoti gamintoj\u0173 ir akredituoti DKMS\/EBMT:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Hamburgo-Eppendorfo universiteto medicinos centras (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 Miuncheno klinikinis centras:<\/strong> <a href=\"https:\/\/www.lmu-klinikum.de\" target=\"_blank\" rel=\"noopener\">lmu-klinikum.de<\/a><\/li>\n\n\n\n<li><strong>Heidelbergo universitetin\u0117 ligonin\u0117 \/ KiTZ:<\/strong> <a href=\"https:\/\/www.kitz-heidelberg.de\" target=\"_blank\" rel=\"noopener\">kitz-heidelberg.de<\/a> <em>(taip pat: PRAME tyrimai)<\/em><\/li>\n\n\n\n<li><strong>Frankfurto universitetin\u0117 ligonin\u0117:<\/strong> <a href=\"https:\/\/www.uniklinik-frankfurt.de\" target=\"_blank\" rel=\"noopener\">uniklinik-frankfurt.de<\/a><\/li>\n\n\n\n<li><strong>Freiburgo universiteto medicinos centras:<\/strong> <a href=\"https:\/\/www.uniklinik-freiburg.de\" target=\"_blank\" rel=\"noopener\">uniklinik-freiburg.de<\/a><\/li>\n\n\n\n<li><strong>Diuseldorfo universitetin\u0117 ligonin\u0117 \/ Esenas:<\/strong> specializuojasi MCL\/DLBCL-CAR-T srityje.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>I\u0161samus sertifikuot\u0173 CAR-T centr\u0173 s\u0105ra\u0161as:<\/strong> <a href=\"https:\/\/www.ebmt.org\/registry\/center-search\" target=\"_blank\" rel=\"noopener\">EBMT centro paie\u0161ka<\/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>Perspektyvos: Kas toliau?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Tikimasi, kad kita patvirtint\u0173 imunini\u0173 l\u0105steli\u0173 terapijos metod\u0173 banga ateis 2026-2028 m:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>IMA203 \/ Anzu-cel (PRAME-TCR):<\/strong> Atliekamas 3 etapo SUPRAME tyrimas - <em>Galimas leidimas melanomai 2027\/2028 m.<\/em><\/li>\n\n\n\n<li><strong>Lifileucel + pembrolizumabas (3 faz\u0117):<\/strong> Pirmosios eil\u0117s tyrimas NCT05727904 - <em>Galimas pirmos eil\u0117s melanomos patvirtinimas<\/em><\/li>\n\n\n\n<li><strong>Brenetafusp (PRISM-MEL-301):<\/strong> 3 etapo tyrimas PRAME\u00d7CD3-Bispecifinis - <em>Galimas leidimas 2027 m.<\/em><\/li>\n\n\n\n<li><strong>CAR-T autoimunin\u0117ms ligoms (I\u0160L, i\u0161s\u0117tin\u0117 skleroz\u0117) gydyti:<\/strong> Atliekami 2 faz\u0117s bandymai; potencialiai pirmasis neonkologinis CAR-T produktas<\/li>\n\n\n\n<li><strong>KiTZ Heidelbergo pediatrinis PRAME tyrimas:<\/strong> planuojama 2026 m. - pirmoji pasaulyje studija vaikams<\/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>Imunini\u0173 l\u0105steli\u0173 terapijos kompensavimas Vokietijoje<span class=\"ez-toc-section-end\"><\/span><\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">B\u016bkl\u0117 02.2026<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Situacija yra sud\u0117tinga ir labai skiriasi priklausomai nuo gydymo r\u016b\u0161ies, produkto ir sveikatos draudimo bendrov\u0117s. N\u0117ra vienodo dyd\u017eio automatinio kompensavimo, kaip tradicini\u0173 vaist\u0173 atveju. Vietoj to egzistuoja daugiapakop\u0117 sistema su didele biurokratija, kuri\u0105 gydytojai ir klinikos atvirai kritikuoja kaip neveikian\u010di\u0105.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CAR-T-Zelltherapien\"><\/span>CAR-T l\u0105steli\u0173 terapijos<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Paprastai gr\u0105\u017einama, bet sud\u0117tinga<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"AMNOG_NUB-Verfahren\"><\/span>AMNOG ir NUB proced\u016bra<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">CAR-T preparatai yra <strong>Pa\u017eangiosios terapijos vaistai (ATMP)<\/strong> ir jiems taikoma Vokietijos <strong>AMNOG proced\u016bra<\/strong> (Farmacijos rinkos reorganizavimo \u012fstatymas). Jame numatyta<\/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 atliekamas i\u0161ankstinis naudos vertinimas<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Nuo 2011 m. sausio 1 d. G-BA pagal \u012fstatym\u0105 turi atlikti vis\u0173 naujai registruot\u0173 vaist\u0173, kuri\u0173 sud\u0117tyje yra nauj\u0173 veikli\u0173j\u0173 med\u017eiag\u0173, naudos vertinim\u0105 i\u0161 karto po j\u0173 patekimo \u012f rink\u0105.<br>Tiriama, ar naujas vaistas yra prana\u0161esnis u\u017e ankstesn\u012f standartin\u012f gydym\u0105 - vadinam\u0105j\u012f <strong>tinkama lyginamoji terapija<\/strong> - suteikia prana\u0161um\u0105.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Teisinis pagrindas:<\/strong> <a href=\"https:\/\/www.gesetze-im-internet.de\/sgb_5\/__35a.html\" target=\"_blank\" rel=\"noopener\">\u00a7 35a SGB V straipsnis - Vaist\u0173 naudos vertinimas (teisin\u0117 formuluot\u0117)<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Proced\u016bros apra\u0161ymas 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 naudos vertinimas pagal SGB V 35a straipsn\u012f<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0160io naudos vertinimo rezultatas yra pradinis ta\u0161kas GKV-Spitzenverband ir vaist\u0173 gamintojo deryboms d\u0117l kainos.<br>Galimos prid\u0117tin\u0117s naudos vertinimo kategorijos apibr\u0117\u017etos Vokietijos reglamente d\u0117l pagalbos vaistui vertinimo ir G-BA proced\u016bros kodekso 5 skyriuje.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Keturios papildom\u0173 i\u0161mok\u0173 kategorijos:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Reik\u0161mingas<\/strong> Papildoma nauda<\/li>\n\n\n\n<li><strong>Nema\u017eai<\/strong> Papildoma nauda<\/li>\n\n\n\n<li><strong>\u017demiau<\/strong> Papildoma nauda<\/li>\n\n\n\n<li><strong>N\u0117ra<\/strong> \u012erodyta papildoma nauda<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Keturios kategorijos originalioje formuluot\u0117je:<\/strong> <a href=\"https:\/\/www.g-ba.de\/themen\/arzneimittel\/arzneimittel-richtlinie-anlagen\/nutzenbewertung-35a\/zusatznutzen\/\" target=\"_blank\" rel=\"noopener\">g-ba.de - Prid\u0117tin\u0117s vert\u0117s kategorijos<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Kategorij\u0173 teisinis pagrindas:<\/strong> <a href=\"https:\/\/www.gesetze-im-internet.de\/am-nutzenv\/BJNR232400010.html\" target=\"_blank\" rel=\"noopener\">AM-NutzenV 5 straipsnio 7 dalis - Nutarimas d\u0117l vaist\u0173 i\u0161mok\u0173 vertinimo (teisin\u0117 formuluot\u0117)<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Konkretus pavyzdys: \"Yescarta\" (CAR-T) G-BA proced\u016bra:<\/strong> <a href=\"https:\/\/www.g-ba.de\/bewertungsverfahren\/nutzenbewertung\/406\/\" target=\"_blank\" rel=\"noopener\">g-ba.de - Naudos vertinimo proced\u016bra Axicabtagene-Ciloleucel<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Visos vykdomos ir u\u017ebaigtos G-BA vertinimo proced\u016bros:<\/strong> <a href=\"https:\/\/www.g-ba.de\/bewertungsverfahren\/nutzenbewertung\/\" target=\"_blank\" rel=\"noopener\">g-ba.de - Vertinimo proced\u016bros ap\u017evalga<\/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>Derybos d\u0117l kainos pagal SGB 130b straipsn\u012f V<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Remdamiesi G-BA sprendimu d\u0117l naujo vaisto papildomos naudos, GKV-Spitzenverband ir farmacijos bendrov\u0117 paprastai per \u0161e\u0161is m\u0117nesius keturiuose deryb\u0173 susitikimuose derasi d\u0117l vadinamosios kompensacijos sumos. Nuo septintojo m\u0117nesio po pateikimo \u012f rink\u0105 ji taikoma kaip nauja visoje \u0161alyje galiojanti vaisto i\u0161davimo kaina - tiek apdraustiesiems privalomuoju sveikatos draudimu, tiek privatiems draudikams, tiek savaranki\u0161kai mokantiems asmenims.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Teisinis pagrindas:<\/strong> <a href=\"https:\/\/www.gesetze-im-internet.de\/sgb_5\/__130b.html\" target=\"_blank\" rel=\"noopener\">\u00a7 130b SGB V skirsnis - Susitarimai d\u0117l kompensacijos sum\u0173 (\u012fstatymo redakcija)<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Proced\u016bros apra\u0161ymas 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 derybos pagal SGB V \u00a7 130b<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Vis\u0173 kompensavimo sum\u0173, d\u0117l kuri\u0173 der\u0117tasi, ap\u017evalga (\u012fskaitant CAR-T produktus):<\/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 - Susitarimai d\u0117l kompensacijos sumos<\/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 ligonin\u0117ms<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Kadangi CAR-T terapija taikoma stacionare, klinikoms taip pat taikomos <strong>NUB proced\u016bra<\/strong> (Nauji tyrimo ir gydymo metodai pagal KHEntgG 6 straipsnio 2 dal\u012f).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">NUB proced\u016bra panaikina vadinam\u0105j\u012f \u201einovacij\u0173 atotr\u016bk\u012f\u201c, t. y. paprastai trej\u0173 met\u0173 laikotarp\u012f, kol nauja terapija visi\u0161kai \u012ftraukiama \u012f G-DRG fiksuot\u0173j\u0173 \u012fkaini\u0173 sistem\u0105.<br>\u0160iuo laikotarpiu ligonin\u0117s gali der\u0117tis su ligoni\u0173 kasomis d\u0117l konkre\u010dios ligonin\u0117s NUB mokes\u010di\u0173, jei Ligonini\u0173 darbo apmok\u0117jimo sistemos institutas (InEK), atlik\u0119s patikrinim\u0105, suteikia 1 status\u0105.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ligonin\u0117s turi pateikti InEK parai\u0161kas d\u0117l NUB iki kiekvien\u0173 met\u0173 spalio 31 d. Per\u017ei\u016bros rezultatus InEK paskelbia iki kit\u0173 met\u0173 sausio pabaigos.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ATMP (pa\u017eangiosios terapijos vaistiniams preparatams), kuriems priskiriami visi CAR-T ir TCR-T vaistiniai preparatai, taikomas prat\u0119stas parai\u0161k\u0173 pateikimo terminas - kiekvien\u0173 met\u0173 baland\u017eio 30 d., i\u0161skyrus atvejus, kai parai\u0161ka jau pateikta iki spalio 31 d.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>NUB proced\u016bros pareig\u016bnas (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 ATMP<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><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 ligonin\u0117se<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>I\u0161samus proceso paai\u0161kinimas su specialiu ATMP reglamentu:<\/strong> <a href=\"https:\/\/reimbursement.institute\/nub-antrag\/\" target=\"_blank\" rel=\"noopener\">kompensavimas.institutas - NUB u\u017eklausos proced\u016bra<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>AOK 2025 m. NUB ap\u017evalga (su dabartin\u0117s b\u016bkl\u0117s duomenimis):<\/strong> <a href=\"https:\/\/www.aok.de\/gp\/krankenhaus\/verguetung-drg\/nub\" target=\"_blank\" rel=\"noopener\">aok.de\/gp - NUB somatikoje<\/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>Realyb\u0117: individualios parai\u0161kos ir biurokratija<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Nepaisant sutart\u0173 kompensavimo sum\u0173, klinik\u0173 ir pacient\u0173 praktika yra daug sud\u0117tingesn\u0117, nei galima spr\u0119sti i\u0161 oficiali\u0173 taisykli\u0173.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Iki \u0161iol centrai paprastai tur\u0117davo pateikti individual\u0173 pra\u0161ym\u0105 d\u0117l i\u0161laid\u0173 padengimo privalomuoju sveikatos draudimu.<br>N\u0117ra standartizuotos, automatin\u0117s i\u0161laid\u0173 padengimo sistemos, skirtos privalomuoju sveikatos draudimu apdraustiems asmenims.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0160altinis:<\/strong> <a href=\"https:\/\/www.krebsinformationsdienst.de\/fachkreise\/nachrichten\/detail\/update-car-t-zell-therapie\" target=\"_blank\" rel=\"noopener\">DKFZ V\u0117\u017eio informacijos tarnyba - Atnaujinta informacija apie CAR-T: bendra parai\u0161k\u0173 teikimo tvarka ir susitarimai d\u0117l nuolaid\u0173<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kadangi CAR-T preparatas kainuoja kelis \u0161imtus t\u016bkstan\u010di\u0173 eur\u0173, klinikos, prie\u0161 prad\u0117damos gydym\u0105, turi gauti i\u0161laid\u0173 padengim\u0105. LMU klinikos Miunchene vyresnysis gydytojas daktaras Veitas B\u00fcckleinas (Veit B\u00fccklein) pasakoja, kiek pastang\u0173 reikia \u012fd\u0117ti: \u201eTurime u\u017epildyti kontrolin\u012f s\u0105ra\u0161\u0105 ir surinkti daugyb\u0119, daugyb\u0119 dokument\u0173: nuo A - gydytojo lai\u0161ko iki Z - vis\u0173 i\u0161vad\u0173 suvestin\u0117s.\u201c Oficiali proced\u016bra vadinama \u201eindividuali\u0173 i\u0161laid\u0173 kompensavimo parai\u0161kos proced\u016bra\u201c.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0160altinis:<\/strong> <a href=\"https:\/\/pharma-fakten.de\/news\/car-t-zelltherapie-zukunftsversprechen-versus-burokratiemonster\/\" target=\"_blank\" rel=\"noopener\">Farmacijos faktai - CAR-T: ateities pa\u017eadas ir biurokratijos monstras (LMU Klinikum M\u00fcnchen, 2024 m. rugs\u0117jis)<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Prof. Dr. Marion Subklewe, LMU Klinikum M\u00fcnchen CAR-T programos vadov\u0117, apibendrina kritik\u0105: \u201eDirbame su patvirtintais produktais. Nesuprantu, kod\u0117l kiekvien\u0105 kart\u0105 turiu teikti atskir\u0105 parai\u0161k\u0105 d\u0117l patvirtinto produkto\u201c. Kompensavimo procesai \u0161iuo metu yra \u201epriemon\u0117, kuri apsunkina pa\u017eang\u0105\u201c.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0160altinis:<\/strong> <a href=\"https:\/\/pharma-fakten.de\/news\/car-t-zelltherapien-optimale-versorgung-sieht-anders-aus\/\" target=\"_blank\" rel=\"noopener\">Farmacijos faktai - CAR-T: optimali prie\u017ei\u016bra atrodo kitaip (2025 m. balandis)<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kelno universitetin\u0117s ligonin\u0117s I vidaus lig\u0173 klinikos direktorius, profesorius daktaras Michaelis Hallekas si\u016blo, kad sprendimas b\u016bt\u0173 sistemingai skirti CAR-T l\u0105steli\u0173 terapij\u0105 specializuotiems centrams, kurie dokumentuoja savo darb\u0105 ir gali \u012frodyti, kad j\u0173 veikla yra s\u0117kminga, o tada \u0161iems centrams suteikti laisv\u0105 rank\u0105 priimant sprendimus d\u0117l gydymo: \u201eTada galima pamir\u0161ti apie per\u017ei\u016bros proces\u0105, nes kas kitas, jei ne mes, tur\u0117t\u0173 nuspr\u0119sti, ar gydymas yra tinkamas, ar ne?\u201c<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0160altinis:<\/strong> <a href=\"https:\/\/pharma-fakten.de\/news\/car-t-zelltherapie-woran-es-noch-fehlt\/\" target=\"_blank\" rel=\"noopener\">Farmacijos faktai - CAR-T: ko dar tr\u016bksta (Kelno universitetin\u0117s ligonin\u0117s renginys, 2025 m. liepa)<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Universitetini\u0173 ligonini\u0173 po\u017ei\u016briu, pagrindin\u0117 strukt\u016brin\u0117 problema yra ta, kad teis\u0117s akt\u0173 leid\u0117jas neu\u017ekirto laiko tarpo tarp vaisto leidimo ir ligonini\u0173 garantuotos teis\u0117s \u012f kompensacij\u0105. Nauj\u0173 l\u0105steli\u0173 ir gen\u0173 terapijos metod\u0173 atveju finansin\u0117 rizika ligonin\u0117ms yra per didel\u0117, kad jos gal\u0117t\u0173 atlikti i\u0161ankstinius mok\u0117jimus.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0160altinis:<\/strong> <a href=\"https:\/\/www.uniklinika.de\/gesundheitspolitischethemen\/car-t-zelltherapie\/\" target=\"_blank\" rel=\"noopener\">Uniklinika.de - CAR-T l\u0105steli\u0173 terapija: kompensavimo saugumo poreikis<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Tokio delsimo medicinin\u0117s pasekm\u0117s yra i\u0161matuojamos: jei CAR-T l\u0105steli\u0173 terapijos laukiama vien\u0105 m\u0117nes\u012f, santykinis mirtingumas gali padid\u0117ti 6,2 proc. Bet koks delsimas gauti CAR-T gali tur\u0117ti tiesiogin\u0117s \u012ftakos gydymo s\u0117kmei.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0160altinis:<\/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: optimali prie\u017ei\u016bra atrodo kitaip (su nuoroda \u012f IQVIA tyrim\u0105)<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Be to, yra dar viena strukt\u016brin\u0117 problema: daugiau kaip 160 ligonini\u0173 pateik\u0117 NUB parai\u0161kas, kad gal\u0117t\u0173 si\u016blyti CAR-T terapij\u0105, ta\u010diau i\u0161 prad\u017ei\u0173 joms buvo suteiktas tik 4 NUB statusas, o tai rei\u0161kia, kad pagal NUB susitarimus \u0160TI neprivalo padengti i\u0161laid\u0173.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0160altinis:<\/strong> <a href=\"https:\/\/www.vdek.com\/magazin\/ausgaben\/2018-1112\/politik_car_t_zelltherapie.html\" target=\"_blank\" rel=\"noopener\">VDEK - Revoliucija onkologijoje: NUB statusas ir CAR-T kompensavimo klausimai<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Prof. Subklewe apra\u0161o itin absurdi\u0161k\u0105 pavyzd\u012f i\u0161 kasdienio ligonin\u0117s gyvenimo: \u201eMan reikia pasakyti, kad gastroenterologas turi b\u016bti \u0161alia 24 valandas per par\u0105, nors per pastaruosius penkerius metus man jo niekada neprireik\u0117.\u201c<br>Nors tam tikri kokyb\u0117s ir strukt\u016briniai reikalavimai yra prasmingi, nereik\u0117t\u0173 leisti, kad jie tapt\u0173 nevaldomi, kaip yra dabar.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0160altinis:<\/strong> <a href=\"https:\/\/pharma-fakten.de\/news\/car-t-zelltherapie-zukunftsversprechen-versus-burokratiemonster\/\" target=\"_blank\" rel=\"noopener\">Farmacijos faktai - CAR-T: ateities pa\u017eadas ir biurokratijos monstras<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Kvalifikuot\u0173 CAR-T centr\u0173 Vokietijoje ap\u017evalga<\/strong> (pacientams ir siun\u010diantiems gydytojams):<\/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 gydymo centr\u0173 Vokietijoje ap\u017evalga (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 - Penkeri CAR-T metai: programa ir kontaktai<\/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-l\u0105steli\u0173 terapija: s\u0105naud\u0173 taupymas gaminant pa\u010dioje \u012fmon\u0117je<\/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>\u201eMok\u0117jimo u\u017e rezultatus\u201c modelis<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"> (su darbo rezultatais susijusi kompensacija)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kaip novatori\u0161k\u0105 tarpin\u012f sprendim\u0105, individualios sveikatos draudimo kasos susitar\u0117 d\u0117l vadinamojo <strong>Sutartys, pagal kurias mokama u\u017e veiklos rezultatus<\/strong> u\u017edarytas:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\"Novartis\" ir \"GWQ ServicePlus\" sudar\u0117 \"Kymriah\" kompensavimo model\u012f, pagr\u012fst\u0105 rezultatais, ir tai yra pirmasis tokio pob\u016bd\u017eio susitarimas Vokietijoje:<br>\"Novartis\" kompensuos dal\u012f vaisto i\u0161laid\u0173, jei pacientas mirs nuo kraujo v\u0117\u017eio per nustatyt\u0105 laikotarp\u012f po gydymo. <br>Rezultato parametras yra gydomo paciento i\u0161gyvenamumas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0160is modelis tapo precedentu: \"Techniker Krankenkasse\" ir kitos pakaitin\u0117s ligoni\u0173 kasos taip pat sudar\u0117 pana\u0161ias sutartis.<\/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>Kokie CAR-T preparatai gali b\u016bti kompensuojami Vokietijoje?<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>Produktas<\/th><th>Indikacija<\/th><th>GKV statusas<\/th><\/tr><\/thead><tbody><tr><td><strong>Kymriah<\/strong> (Tisagenlecleucel)<\/td><td>Vaik\u0173 B-ALL, DLBCL, FL<\/td><td>\u2705 Gr\u0105\u017eintina suma, d\u0117l kurios susitarta (nuo 2019 m. rugs\u0117jo m\u0117n.)<\/td><\/tr><tr><td><strong>Yescarta<\/strong> (Axicabtagene-cel)<\/td><td>DLBCL, PMBCL, FL, tFL<\/td><td>\u2705 Gr\u0105\u017eintina suma, d\u0117l kurios susitarta<\/td><\/tr><tr><td><strong>Tecartus<\/strong> (Brexucabtagene-cel)<\/td><td>MCL, suaugusi\u0173j\u0173 B-ALL<\/td><td>Patvirtinta EMA; vykdoma ir (arba) baigta NUB proced\u016bra<\/td><\/tr><tr><td><strong>Breyanzi<\/strong> (Lisocabtagene-cel)<\/td><td>DLBCL, CLL, FL<\/td><td>Patvirtinta EMA; NUB proced\u016bra<\/td><\/tr><tr><td><strong>Abecma<\/strong> (Idecabtagene-cel)<\/td><td>Daugybin\u0117 mieloma<\/td><td>Patvirtinta EMA; NUB proced\u016bra<\/td><\/tr><tr><td><strong>Carvykti<\/strong> (Ciltacabtagene-cel)<\/td><td>Daugybin\u0117 mieloma<\/td><td>Patvirtinta EMA; NUB proced\u016bra<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Praktin\u0117 s\u0105lyga bet kuriuo atveju<\/strong><br>Gydymo centras turi<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>atitinka G-BA ATMP kokyb\u0117s u\u017etikrinimo gaires.<\/li>\n\n\n\n<li>FACT\/JACIE akreditacija<\/li>\n\n\n\n<li>ir gauti CAR-T centro sertifikat\u0105.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Tik tada galima susitarti d\u0117l NUB mokes\u010di\u0173 ir i\u0161ra\u0161yti s\u0105skait\u0105.<\/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) - ypatingas atvejis<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\"Kimmtrak\" yra ne l\u0105steli\u0173 produktas, o <strong>Biofarmacijos<\/strong> ir jam, kaip ir kitiems vaistams nuo v\u0117\u017eio, taikoma \u012fprasta AMNOG proced\u016bra. \u0160is vaistas skiriamas ambulatori\u0161kai ir paprastai kompensuojamas pagal \u012fprastines onkologini\u0173 lig\u0173 s\u0105skait\u0173 i\u0161ra\u0161ymo proced\u016bras, ta\u010diau tik pagal patvirtintas indikacijas (<strong>HLA-A*02:01 teigiama uvealin\u0117 melanoma<\/strong>, pirmoji eilut\u0117).<\/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) - \u0161iuo metu Vokietijoje nekompensuojama<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Tai svarbiausias dabartinis skirtumas, palyginti su JAV.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bendrov\u0117 <em>Iovance<\/em> 2025 m. liepos 22 d. atsi\u0117m\u0117 EMA pateikt\u0105 rinkodaros leidimo parai\u0161k\u0105. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EMA buvo susir\u016bpinusi d\u0117l atsako \u012f pagrindin\u012f tyrim\u0105 da\u017enumo, taip pat d\u0117l rimt\u0173 saugumo problem\u0173, nes kai kuriais atvejais gydymas buvo susij\u0119s su mirtimi.<br>Be to, gamintojas netur\u0117jo pakankamai geros gamybos praktikos dokument\u0173. <a href=\"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.2025.43.16_suppl.TPS2673\" target=\"_blank\" rel=\"noreferrer noopener\">Amerikos klinikin\u0117s onkologijos draugija<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0160iuo metu \"Iovance\" kartu su EMA rengia nauj\u0105 strategij\u0105, kad gaut\u0173 ES leidim\u0105 prekiauti \"Amtagvi\". Tikimasi, kad Jungtin\u0117je Karalyst\u0117je vaistas bus patvirtintas 2026 m. pirm\u0105j\u012f pusmet\u012f; Australijai suteikta prioritetin\u0117 per\u017ei\u016bra. <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 class=\"wp-block-paragraph\"><strong>I\u0161vada Vokietijai:<\/strong> \u0160iuo metu \"Lifileucel\" galima \u012fsigyti ES <strong>Neleid\u017eiama ir nekompensuojama<\/strong>. Pacientai, norintys gauti \u0161\u012f gydym\u0105, \u0161iuo metu turi j\u012f gauti JAV savo l\u0117\u0161omis arba klinikini\u0173 tyrim\u0173 metu.<\/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) - Europoje neleid\u017eiama taikyti<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Afamitresgenas autoleukelis (Tecelra) \u0161iuo metu yra <strong>leid\u017eiama naudoti tik JAV<\/strong> (FDA, 2024 m. rugpj\u016btis). EMA parai\u0161ka dar nepateikta.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Tod\u0117l Vokietijoje galioja tokia tvarka: kompensacijos n\u0117ra, \u012fprastin\u0117 prieiga n\u0117ra, tik klinikini\u0173 tyrim\u0173 arba atskir\u0173 terapini\u0173 tyrim\u0173 b\u016bdu (kaip \"Mailo\" Heidelbergo KiTZ atveju).<\/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>K\u0105 daryti, jei draudimo bendrov\u0117 atsisako? Teisin\u0117s galimyb\u0117s<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Jei privalomojo sveikatos draudimo \u012fstaiga atsisako padengti EMA patvirtinto gydymo i\u0161laidas, galima rinktis \u0161ias galimybes:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Prie\u0161taravimas (SGB V 78 straipsnis)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Per 4 savaites nuo atmetimo ra\u0161tu pateikite prie\u0161taravim\u0105.<\/li>\n\n\n\n<li>Klinika ir gydytojas tur\u0117t\u0173 prid\u0117ti i\u0161sami\u0105 medicinin\u0119 ataskait\u0105.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Socialinis ie\u0161kinys teisme<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Jei sprendimas vis dar neigiamas, pateikite skund\u0105 kompetentingam socialiniam teismui.<\/li>\n\n\n\n<li>Gyvybei pavojing\u0173 lig\u0173 atveju <strong>laikinoji teisin\u0117 apsauga<\/strong> gali b\u016bti teikiama parai\u0161ka, <br>teismas gali laikinai nurodyti prisiimti i\u0161laidas.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00a7 SGB V skyriaus 2 skirsnio 1a dalis (Nikolaus rezoliucija)<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Gyvybei pavojingos ligos atveju, kai n\u0117ra standartinio gydymo, apdraustieji turi teis\u0119 \u012f nestandartin\u012f patvirtint\u0105 gydym\u0105, jei yra rimta tikimyb\u0117, kad liga bus i\u0161gydyta arba pastebimai palengv\u0117s. Tai pagrindin\u0117 teisin\u0117 priemon\u0117 tokiais atvejais, kaip individual\u016bs gydymo bandymai.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Svarb\u016bs i\u0161tekliai:<\/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\">G-BA imunini\u0173 l\u0105steli\u0173 terapijos naudos vertinimas<\/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 \u0161ablonai 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\u0117\u017eio informacijos tarnyba - CAR-T ir 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\">Farmacijos faktai: Biurokratijos problema 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 class=\"wp-block-paragraph\"><strong>Austrija:<\/strong> CAR-T l\u0105steli\u0173 terapija \u012f LKF paslaug\u0173 katalog\u0105 Austrijoje \u012ftraukta 2020 m. sausio 1 d. (grup\u0117 MEL22.30: \u201eModifikuot\u0173 l\u0105steli\u0173 skyrimas\u201c) - taigi reglamentuota anks\u010diau ir ai\u0161kiau nei Vokietijoje. <a href=\"https:\/\/www.clinicaltrialvanguard.com\/news\/t-knife-files-for-phase-1-trial-of-prame-t-cell-therapy\/\" target=\"_blank\" rel=\"noreferrer noopener\">Klinikini\u0173 tyrim\u0173 avangardas<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Schweiz\"><\/span>\u0160veicarija<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0160veicarija:<\/strong> Kompensavimas pagal KVG (Sveikatos draudimo \u012fstatym\u0105), \u012ftraukus \u012f FOPH specialybi\u0173 s\u0105ra\u0161\u0105; i\u0161 esm\u0117s galimas ir EMA patvirtint\u0173 CAR-T preparat\u0173 kompensavimas, taip pat \u012fvertinus atskirus atvejus.<\/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>Santrauka<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 leidimas<\/th><th>SHI kompensacija Vokietija<\/th><\/tr><\/thead><tbody><tr><td>CAR-T (Kymriah, Yescarta, Tecartus, Breyanzi, Abecma, Carvykti)<\/td><td>Taip (EMA)<\/td><td>I\u0161 esm\u0117s taip, ta\u010diau teikiant individuali\u0105 parai\u0161k\u0105 ir (arba) kreipiantis \u012f NUB, o tai susij\u0119 su didele biurokratija.<\/td><\/tr><tr><td>Kimmtrak (Tebentafusp)<\/td><td>Taip (EMA)<\/td><td>Taip (AMNOG proced\u016bra, ambulatorin\u0117)<\/td><\/tr><tr><td>\"Lifileucel\" \/ \"Amtagvi\" (TIL)<\/td><td>Ne (EMA parai\u0161ka atsiimta 2025 m. liepos m\u0117n.)<\/td><td>Ne<\/td><\/tr><tr><td>Afami-cel \/ Tecelra (TCR-T)<\/td><td>Ne (tik FDA)<\/td><td>Ne<\/td><\/tr><tr><td>PRAME-TCR (IMA203, eksperimentinis)<\/td><td>Ne (3 etapas)<\/td><td>Ne - tik dalyvaujant tyrime<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Pagrindin\u0117 politin\u0117 problema i\u0161lieka: Iki \u0161iol n\u0117ra geros teisin\u0117s ir finansin\u0117s sistemos, kuri leist\u0173 greitai ir patikimai atspind\u0117ti \u0161iuos inovatyvius gydymo b\u016bdus Vokietijos sistemoje. Gali praeiti ne vieneri metai, kol medicinos naujovi\u0173 s\u0105naudos bus teisingai atspind\u0117tos fiksuoto \u012fkainio u\u017e kiekvien\u0105 atvej\u012f sistemoje.<\/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 ir imunini\u0173 l\u0105steli\u0173 terapija - visa teisin\u0117 situacija<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Statusas: 2026 m. vasario m\u0117n.<\/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>Teisinis pagrindas: 2009 m. VVG 192 straipsnis ir MB\/KK<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Medicinini\u0173 i\u0161laid\u0173 draudimo atveju draudikas privalo atlyginti medicini\u0161kai b\u016btino gydymo d\u0117l ligos ar nelaimingo atsitikimo pasekmi\u0173 i\u0161laidas sutarta apimtimi. Draudikas neprivalo mok\u0117ti draudimo i\u0161mok\u0173, jei gydymo i\u0161laidos ar kitos i\u0161mokos yra akivaizd\u017eiai neproporcingos numatytoms i\u0161mokoms.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Teisin\u0117 formuluot\u0117 \u00a7 192 VVG (i\u0161sami):<\/strong> <a href=\"https:\/\/dejure.org\/gesetze\/VVG\/192.html\" target=\"_blank\" rel=\"noopener\">dejure.org - VVG 192 straipsnis Tipin\u0117s draudiko sutartin\u0117s i\u0161mokos<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Oficialaus pavyzd\u017eio s\u0105lygos 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 - 2009 m. MB\/KK pavyzd\u017eio s\u0105lygos<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Priva\u010di\u0173 sveikatos draudik\u0173 \u012fsipareigojimai teikti i\u0161mokas i\u0161 esm\u0117s priklauso nuo konkre\u010diu atveju pasirinkto tarifo ir susijusi\u0173 tarifo s\u0105lyg\u0173. Pagal VVG 192 straipsnio 1 dal\u012f kartu su MB\/KK kompensuojamos b\u016btinojo medicininio gydymo d\u0117l ligos ar nelaimingo atsitikimo pasekmi\u0173 i\u0161laidos.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>PKV i\u0161mok\u0173 \u012fsipareigojimo paai\u0161kinimas pagal VVG 192 straipsn\u012f:<\/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 prievol\u0117 mok\u0117ti: kada ir u\u017e k\u0105 PKV turi mok\u0117ti?<\/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>Pagrindin\u0117 s\u0105voka: \u201emedicini\u0161kai b\u016btinas gydymas\u201c.\u201c<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Pagal nusistov\u0117jusi\u0105 teism\u0173 praktik\u0105 ir vadovaujantis MB\/KK pavyzdin\u0117mis s\u0105lygomis bei VVG 192 straipsniu, medicininis b\u016btinumas egzistuoja, jei gydymas, remiantis objektyviais medicininiais duomenimis ir \u017einiomis, yra tinkamas ligai atpa\u017einti ir i\u0161gydyti, u\u017ekirsti keli\u0105 jos pa\u016bm\u0117jimui arba palengvinti simptomus. Lemiamas veiksnys yra tai, ar, kompetentingo gydytojo nuomone, gydymo metu priemon\u0117 atrodo b\u016btina pagal pripa\u017eintus mokslinius standartus.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Teisin\u0117 analiz\u0117: medicininio b\u016btinumo apibr\u0117\u017etis priva\u010diame sveikatos draudime:<\/strong> <a href=\"https:\/\/kanzlei-neue-kraeme.de\/erstattung-kostenintensiver-behandlungsmassnahmen-in-der-pkv\/\" target=\"_blank\" rel=\"noopener\">kanzlei-neue-kraeme.de - S\u0105naud\u0173 reikalaujan\u010di\u0173 gydymo priemoni\u0173 kompensavimas priva\u010diame sveikatos draudime<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Be tradicin\u0117s medicinos pripa\u017eint\u0173 gydymo b\u016bd\u0173, privatus sveikatos draudimas taip pat kompensuoja gydymo b\u016bdus, kurie praktikoje pasirod\u0117 es\u0105 vienodai perspektyv\u016bs arba kuriems n\u0117ra alternatyvos. Tai taip pat gali b\u016bti nauji vaistai arba naujovi\u0161kos diagnostikos proced\u016bros ir gydymo metodai, kuriuos ekspertai laiko naudingais.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>PKV asociacija: oficialus i\u0161mok\u0173 ir kompensavimo paai\u0161kinimas (\u012fskaitant naujovi\u0161kus gydymo b\u016bdus):<\/strong> <a href=\"https:\/\/www.pkv.de\/wissen\/private-krankenversicherung\/leistungen-und-erstattung\/\" target=\"_blank\" rel=\"noopener\">pkv.de - Priva\u010dios sveikatos draudimo i\u0161mokos ir kompensacijos<\/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>Pagrindinis sprendimas: OLG Frankfurt, 2022 6 29 - Ref. 7 U 140\/21<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Tai yra pagrindinis sprendimas d\u0117l imunini\u0173 l\u0105steli\u0173 terapijos kompensavimo i\u0161 privataus sveikatos draudimo Vokietijoje.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Bylos faktai<\/strong><br>Pacientui buvo diagnozuotas neoperuojamas kasos navikas. Po nes\u0117kmingos chemoterapijos jis nusprend\u0117 atsisakyti standartinio paliatyvaus gydymo, kurio s\u0117km\u0117s prognoz\u0117 buvo ma\u017eesn\u0117, ir pasirinko dendritini\u0173 l\u0105steli\u0173 terapij\u0105. Jis nor\u0117jo reikalauti padengti i\u0161laidas i\u0161 savo priva\u010dios sveikatos draudimo bendrov\u0117s, ta\u010diau ji atsisak\u0117 apmok\u0117ti visas i\u0161laidas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Sprendimas<\/strong><br>Dendritini\u0173 l\u0105steli\u0173 terapija yra medicininis gydymas, kaip apibr\u0117\u017eta priva\u010di\u0173 sveikatos draudimo bendrovi\u0173 medicinos i\u0161laid\u0173 s\u0105lygose (MB\/KK 2009). Jei \u012fprastinis pirmos eil\u0117s gydymas nepadeda pasiekti norimos gydymo s\u0117km\u0117s asmeniui, sergan\u010diam gyvybei pavojingu ir nepagydomu naviku, apdraustasis neturi b\u016bti nukreipiamas antros eil\u0117s gydymui, kurio efektyvumo prognoz\u0117 yra dar ma\u017eesn\u0117. Prie\u0161ingai, jie gali reikalauti tiesiogiai apmok\u0117ti naujo, moksli\u0161kai pagr\u012fsto alternatyvaus gydymo i\u0161laidas, jei gydymo metu jis turi ne visai menk\u0105 perspektyv\u0105 pasiekti s\u0117km\u0119, palyginti su standartiniu paliatyviniu gydymu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>I\u0161samus teismo sprendimo aptarimas (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\">datav-magazin.de - OLG Frankfurtas: PKV turi padengti dendritini\u0173 l\u0105steli\u0173 terapijos i\u0161laidas<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Sprendimo per\u017ei\u016bra ir teisin\u0117s galios patvirtinimas (2023 m. sausio m\u0117n.):<\/strong> <a href=\"https:\/\/transkript.de\/artikel\/2023\/krankenkasse-muss-zelltherapie-zahlen\/\" target=\"_blank\" rel=\"noopener\">transkript.de - Sveikatos draudimo bendrov\u0117 privalo mok\u0117ti u\u017e l\u0105steli\u0173 terapij\u0105 (\u012fskaitant teisin\u0117s galios patvirtinim\u0105)<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Ligonini\u0173 vertinimo analiz\u0117 (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 turi padengti alternatyvaus gydymo i\u0161laidas<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Haufe: Trumpa sprendimo santrauka:<\/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 - Neoperabilus navikas: alternatyvus gydymas, kuriam taikoma PKV<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>I\u0161sami teismo sprendim\u0173 analiz\u0117 (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 - Dendritini\u0173 l\u0105steli\u0173 gydymo i\u0161laid\u0173 kompensavimas, OLG Frankfurtas<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Teisin\u0117 galia:<\/strong> Heseno auk\u0161tesniojo apygardos teismo teigimu, terminas apeliaciniam skundui pateikti baig\u0117si, o tai rei\u0161kia, kad sprendimas yra teisi\u0161kai privalomas nuo 2023 m. sausio m\u0117n.<\/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>\u201eAkivaizdi disproporcija\u201c pagal VVG 192 straipsnio 2 dal\u012f ir kod\u0117l ji netaikoma CAR-T<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Pareiga pateikti ir \u012frodyti akivaizd\u017eios disproporcijos buvim\u0105 tenka draudikui. Sutariama, kad lemiam\u0105 reik\u0161m\u0119 turi suteiktos paslaugos \u012fprastin\u0117 vert\u0117, o ne medicininio minimumo kaina. Taikant Federalinio Teisingumo Teismo praktik\u0105 d\u0117l lupikavimo nusikaltim\u0173, rinkos palyginimas yra tinkama priemon\u0117 objektyviai vertei nustatyti.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kadangi CAR-T terapijos kainos visame pasaulyje yra pana\u0161ios (250 000-600 000 eur\u0173), \u201eakivaizd\u0173 disbalans\u0105\u201c galima paneigti palyginus tarptautin\u0119 rink\u0105.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u201eAkivaizd\u017eios disproporcijos\u201c pagal VVG 192 straipsnio 2 dal\u012f teisin\u0117 analiz\u0117:<\/strong> <a href=\"https:\/\/www.kunzrechtsanwaelte.de\/aktuelles\/urteile\/versicherung-und-haftung\/krankenversicherung\" target=\"_blank\" rel=\"noopener\">kunzrechtsanwaelte.de - D\u0117l akivaizd\u017eios disproporcijos pagal VVG 192 straipsnio 2 dal\u012f<\/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>I\u0161ankstinio tyrimo proced\u016bra pagal VVG 192 straipsnio 8 dal\u012f - svarbiausias praktinis \u017eingsnis<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Kai tik numatoma, kad numatomos gydymo i\u0161laidos vir\u0161ys 2 000 EUR, apdraustieji turi teis\u0119 gauti informacij\u0105 apie \u012fsipareigotas i\u0161laidas pagal VVG 192 straipsnio 8 dal\u012f. Per 4 savaites nuo i\u0161laid\u0173 s\u0105matos pateikimo draudimo \u012fmon\u0117 turi patvirtinti arba atmesti i\u0161laid\u0173 prisi\u0117mim\u0105.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Jei per nustatyt\u0105 termin\u0105 informacija nepateikiama, draudikas daro prielaid\u0105, kad numatomas gydymas yra b\u016btinas, kol ne\u012frodoma prie\u0161ingai. \u0160is <strong>B\u016btinyb\u0117s fikcija<\/strong> nes\u0117kmingo reagavimo atveju yra svarbi pacient\u0173 apsaugos priemon\u0117.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u012estatymo formuluot\u0117 VVG 192 straipsnio 8 dalis (pareiga i\u0161 anksto pasiteirauti):<\/strong> <a href=\"https:\/\/dejure.org\/gesetze\/VVG\/192.html\" target=\"_blank\" rel=\"noopener\">dejure.org - VVG 192 straipsnio 8 dalis<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Praktiniai nurodymai: i\u0161ankstin\u0117 u\u017eklausa PKV prie\u0161 pradedant brangiai kainuojant\u012f gydym\u0105:<\/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 draudimas ir brangus gydymas: koks po\u017ei\u016bris teisingas?<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Teisin\u0117s neteisingos arba tr\u016bkstamos PKV informacijos pasekm\u0117s:<\/strong> <a href=\"https:\/\/www.versicherungsrechtsiegen.de\/krankenhauskosten-zusatzversicherung-kostenerstattung-fuer-aufenthalt-in-privatklinik\/\" target=\"_blank\" rel=\"noopener\">versicherungsrechtsiegen.de - I\u0161laid\u0173 \u012fsipareigojimas ir VVG 192 straipsnio 8 dalis praktikoje<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Bei_Ablehnung_Rechtsmittel_und_Klage\"><\/span>Atmetimo atveju: apeliacija ir ie\u0161kinys<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Kompensacijos klausimas sprend\u017eiamas atsi\u017evelgiant \u012f VVG 192 straipsnio, MB\/KK pavyzdini\u0173 s\u0105lyg\u0173 ir atskir\u0173 tarif\u0173 nuostat\u0173 s\u0105veik\u0105. Lemiam\u0105 reik\u0161m\u0119 turi tai, ar gydymas buvo atliktas d\u0117l ligos ir ar jis buvo medicini\u0161kai b\u016btinas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Jei PKV atmeta parai\u0161k\u0105, galima pasinaudoti \u0161iomis galimyb\u0117mis:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Prie\u0161taravimas su i\u0161samiais medicininiais dokumentais<\/strong> (gydytojo nuomon\u0117, naviko komisijos protokolas, tarptautinio tyrimo situacija, i\u0161laid\u0173 s\u0105mata)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Ie\u0161kinys civiliniame teisme<\/strong> (ne socialinis teismas, tuo skiriasi nuo privalomojo sveikatos draudimo) su pra\u0161ymu taikyti laikin\u0105j\u0105 apsaugos priemon\u0119, jei b\u016btina skubiai suteikti gydym\u0105.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>I\u0161samus vadovas: U\u017egin\u010dyti PKV atsisakym\u0105, prie\u0161taravim\u0105 ir teisinius veiksmus:<\/strong> <a href=\"https:\/\/kanzlei-neue-kraeme.de\/erstattung-kostenintensiver-behandlungsmassnahmen-in-der-pkv\/\" target=\"_blank\" rel=\"noopener\">kanzlei-neue-kraeme.de - Brangiai kainuojan\u010dio gydymo kompensavimas pagal privat\u0173 sveikatos draudim\u0105<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Atsisakymas privataus sveikatos draudimo ir i\u0161mok\u0173: teisiniai \u017eingsniai i\u0161 pirmo \u017evilgsnio:<\/strong> <a href=\"https:\/\/kva-plus.de\/ablehnung-der-kostenuebernahme-durch-die-pkv-und-beihilfe\/\" target=\"_blank\" rel=\"noopener\">kva-plus.de - Atsisakymas padengti i\u0161laidas i\u0161 privataus sveikatos draudimo ir valstyb\u0117s pagalba<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p><span class=\"span-reading-time rt-reading-time\" style=\"display: block;\"><span class=\"rt-label rt-prefix\">Skaitymo laikas<\/span> <span class=\"rt-time\"> 20<\/span> <span class=\"rt-label rt-postfix\">minut\u0117s<\/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\/lt\/blog\/2026\/02\/19\/immunzelltherapie\/\" rel=\"bookmark\">Skaityti daugiau \"<span class=\"screen-reader-text\">Imunini\u0173 l\u0105steli\u0173 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\/lt\/wp-json\/wp\/v2\/posts\/12789","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/csiag.eu\/lt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csiag.eu\/lt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csiag.eu\/lt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/csiag.eu\/lt\/wp-json\/wp\/v2\/comments?post=12789"}],"version-history":[{"count":0,"href":"https:\/\/csiag.eu\/lt\/wp-json\/wp\/v2\/posts\/12789\/revisions"}],"wp:attachment":[{"href":"https:\/\/csiag.eu\/lt\/wp-json\/wp\/v2\/media?parent=12789"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csiag.eu\/lt\/wp-json\/wp\/v2\/categories?post=12789"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csiag.eu\/lt\/wp-json\/wp\/v2\/tags?post=12789"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}