Ngomhlaka-11 Okthoba, 2024, i-National Medical Product Administration (NMPA) yaseShayina ivumile isicelo se-Investigational New Drug (IND) se-I-Inaticabtagene Autoleucel (Injection ye-CNCT19), ukwelashwa kwamaseli e-antigen receptor (CAR)-T okuqondiswe ku-CD19, ukwelapha i-immunothrombocytopenia ye-systemic lupus erythematosus (SLE - ITP). Lena yi-IND yokuqala ye-Inaticabtagene Autoleucel evunyelwe isifo sokuzivikela komzimba eShayina.
I-Inaticabtagene Autoleucel ingumkhiqizo wokwelapha amaseli e-CD19 CAR-T, ofakwe i-CD19 scFv（HI19a）ehlukile kanye nezinqubo zokukhiqiza ezithuthukisiwe. I-Inaticabtagene Autoleucel ingumkhiqizo wokuqala we-CAR-T oqondiswe ku-CD19 okhuliswe ekhaya eShayina, kanye nomkhiqizo wokuqala wokwelapha amaseli e-CAR-T othengiswayo we-B-ALL eShayina. I-Inaticabtagene Autoleucel yandisa ukusetshenziswa kwayo kwezinkomba eziningana, kufaka phakathi i-r/r B-ALL yabantu abadala, i-r/r DLBCL, i-r/r B-ALL yezingane kanye nentsha, kanye nezifo ezahlukahlukene zokuzivikela komzimba. Isicelo sayo Esisha Semithi (NDA) sokwelapha i-Relapsed noma Refractory Large B-Cell Lymphoma samukelwe yi-NMPA ngoSepthemba 2024.
I-SLE yisifo esihlasela umzimba wonke, esivame ukuholela ekulimaleni kwezitho eziningi. Amaseli e-B angajwayelekile kanye ne-autoantibody kudlala indima ebalulekile ekuqaliseni kwe-SLE. I-SLE ingabangela ukubhujiswa kwama-platelet ngokweqile, okungukuthi i-SLE-ITP. I-SLE-ITP yenzeka cishe ku-16% weziguli zaseShayina ze-SLE, iningi leziguli ze-SLE-ITP aliphenduli kahle kuma-steroids, ama-immunoinhibitors, kanye nemithi yebhayoloji, futhi livame ukuba sengozini enkulu yokopha kwezitho, kuyilapho ukusinda kwazo isikhathi eside kukubi kakhulu.
NgoJulayi walo nyaka, iphephandaba elidumile elithi "The New England Journal of Medicine"ishicilele ucwaningo oluthi “Amaseli e-Anti-CD19 CAR T ku-refractory immune thrombocytopenia ye-SLE,” olubhalwe ngokubambisana nguSolwazi Zeng Xiaofeng noSolwazi Li Mengtao abavela eMnyangweni we-Rheumatology kanye noSolwazi Zhou Daobin abavela eMnyangweni we-Hematology we-Peking Union Medical College Hospital. Ucwaningo lubonise ukusebenza kahle nokuphepha kwe-Inaticabtagene Autoleucel ekwelapheni i-SLE-ITP, luqokomisa amandla amakhulu okwelashwa kwamaseli e-CAR-T.
Owesifazane oneminyaka engu-38 ubudala wathola ukuxilongwa kwe-SLE ngo-2014 futhi waba ne-reversible proteinuria kanye ne-arthritis kanye ne-persistent thrombocytopenia. Ukwelashwa kwangaphambilini nge-glucocorticoids enesilinganiso esiphezulu (ama-methylprednisolone pulses), i-hydroxychloroquine, i-intravenous immune globulin, i-tacrolimus, i-cyclosporin A, i-sirolimus, i-rituximab, i-danazol, i-elthrombopag, kanye ne-recombinant human thrombopoietin akuzange kuyinciphise i-thrombocytopenia. Izibalo zama-platelet zagcinwa ku-10,000 kuya ku-20,000 nge-cubic millimeter ngayinye futhi ekugcineni zehla ngaphansi kuka-10,000 nge-cubic millimeter ngayinye ngoJulayi 2023.
Ngaleso sikhathi, wavezwa yi-purpura kanye nama-ecchymoses ezithweni zakhe, ama-blisters egazi lomlomo, kanye nokopha kwegazi esiswini. I-bone marrow smear yakhe yabonisa i-myeloproliferation esebenzayo kanye nokuphazamiseka kokuvuthwa kwe-megakaryocyte. I-prednisone ephansi kuphela (5 mg ngosuku) kanye ne-hydroxychloroquine (0.2 g ngosuku) yanikezwa ngenyanga ngaphambi kokufakwa kwe-CAR T-cell. I-Autologous fresh leukapheresis yasetshenziswa ukukhiqiza i-inati-cel. Amaseli e-CD19 CAR T angu-500,000 ngekhilogramu yesisindo somzimba anikezwa ngemuva kokuba isiguli sithole i-lymphodepleting chemotherapy nge-fludarabine (ngomthamo ongu-25 mg ngemitha yesikwele yendawo yomzimba) ngosuku ngezinsuku ezingu-−5, −4, kanye no-−3 kanye ne-cyclophosphamide (ngomthamo ongu-250 mg ngemitha yesikwele) ngezinsuku ezingu-−5 kanye no-−4 ngaphambi kokwelashwa kwe-CAR T-cell.
Ngemva kokufakwa kwe-Inaticabtagene Autoleucel Injection, inani lama-platelet esiguli laqhubeka nokwenyuka, futhi impendulo ephelele yezokwelapha yatholakala, futhi ama-glucocorticoids nawo wonke ama-immunosuppressants ayekwa. Njengamanje, isiguli sesibuyele empilweni evamile.
Njengamanje, kunezinye izivivinyo eziningi ze-CAR-T eShayina, futhi zifuna iziguli. Ukuze uthole ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Email：myimmnet@163.com
IZINKOMBA
1.http://www.juventas.cn/news.php?id=711
2.https://www.nejm.org/doi/full/10.1056/NEJMc2403743
Isikhathi sokuthunyelwe: Novemba-08-2024