Ubushakashatsi ku miti mishya yemewe ku ndwara za Inaticabtagene Autoleucel zivura indwara ziterwa n'ubwirinzi bw'umubiri

Ku itariki ya 11 Ukwakira, 2024, Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi mu Bushinwa (NMPA) cyemeje ubusabe bw’Umuti Mushya w’Iperereza (IND) woInaticabtagene Autoleucel (CNCT19 Injection), uburyo bwo kuvura selile za CD19-targetted autologous chimeric antigen receptor (CAR)-T, kugira ngo buvure indwara ya lupus erythematosus (SLE - ITP) y’umubiri. Iyi ni yo IND ya mbere ya Inaticabtagene Autoleucel yemejwe mu Bushinwa ku ndwara y’ubwiyongere bw’umubiri.

Inaticabtagene Autoleucel ni umuti wo kuvura selile za CD19 CAR-T, ufite CD19 scFv（HI19a） yihariye hamwe n’uburyo bwo gukora bugezweho. Inaticabtagene Autoleucel ni wo muti wa mbere wa CAR-T wihariye wakorewe mu Bushinwa, ukaba n’umuti wa mbere wa CAR-T wagurishijwe ku isoko muri B-ALL mu Bushinwa. Inaticabtagene Autoleucel irimo kwagura ikoreshwa ryayo ku bimenyetso bitandukanye, birimo r/r B-ALL ku bantu bakuru, r/r DLBCL, abana n’ingimbi r/r B-ALL, hamwe n’indwara zitandukanye ziterwa n’umubiri. Umuti wayo mushya (NDA) wo kuvura Lymphoma ya B-cell B yasubiwemo cyangwa yasubitswe yemejwe na NMPA muri Nzeri 2024.

SLE ni indwara iterwa n’ubwiyongere bw’umubiri, akenshi igatera kwangirika kw’ingingo nyinshi. Uturemangingo twa B tudasanzwe hamwe na autoantibody bigira uruhare runini mu gutera indwara ya SLE. SLE ishobora gutera kwangirika gukabije kwa platelet, ari byo SLE-ITP. SLE-ITP igaragara ku barwayi bo mu Bushinwa bagera kuri 16% by’abarwayi ba SLE, abenshi mu barwayi ba SLE-ITP basubiza nabi cyane imiti ya steroid, iy’imyuga ibuza umubiri gukora imibonano mpuzabitsina, n’imiti ya biyoloji, kandi akenshi bagira ibyago bikomeye byo kuva amaraso mu ngingo, mu gihe ubuzima bwabo bw’igihe kirekire buba buke cyane.

Muri Nyakanga uyu mwaka, ikinyamakuru cy’ubuganga cy’icyamamare cyitwa “The New England Journal of Medicine”yasohoye ubushakashatsi bugira buti “Anti-CD19 CAR T cells mu ndwara ya SLE idakira,” bwanditswe na Porofeseri Zeng Xiaofeng na Porofeseri Li Mengtao bo mu Ishami ry’Ubuvuzi bw’Amagufwa na Porofeseri Zhou Daobin wo mu Ishami ry’Ubuvuzi bw’Amagufwa mu Bitaro bya Peking Union Medical College. Ubu bushakashatsi bwerekanye imikorere n’umutekano bya Inaticabtagene Autoleucel mu kuvura SLE-ITP, bugaragaza ubushobozi bunini bwo kuvura CAR-T cells.

Umugore w'imyaka 38 yasuzumwe indwara ya SLE mu 2014 maze arwara poroteyine isubira inyuma ndetse n'indwara ya rubagimpande ndetse n'indwara ya thrombocytopenia idakira. Ubuvuzi bwakozwe mbere hakoreshejwe glucocorticoids nyinshi (methylprednisolone pulses), hydroxychloroquine, intravenous immune globulin, tacrolimus, cyclosporin A, sirolimus, rituximab, danazol, eltrombopag, na recombinant human thrombopoietin ntibwagabanyije thrombocytopenia. Umubare wa platelets wakomeje kuba hagati ya 10.000 na 20.000 kuri milimetero kibe, amaherezo ugabanuka munsi ya 10.000 kuri milimetero kibe muri Nyakanga 2023.

Muri icyo gihe, yagaragayeho purpura na ecchymoses ku maguru ye, udusebe tw'amaraso yo mu kanwa, no kuva amaraso mu nda. Isuzuma rye ry'umusemburo ryerekanye ko myeloproliferation ikomeye ndetse no kwangirika kwa megakaryocyte. Prednisone yo ku gipimo gito (5 mg ku munsi) na hydroxychloroquine (0.2 g ku munsi) ni byo byatanzwe mu kwezi kwabanjirije ikoreshwa rya CAR T-cell. Autologous fresh leukapheresis yakoreshejwe mu gukora inati-cell. Uturemangingo 500.000 twa CD19 CAR T kuri kilo y'uburemere bw'umubiri twatanzwe nyuma yuko umurwayi ahawe lymphodepleting chemotherapy hamwe na fludarabine (ku gipimo cya 25 mg kuri metero kare y'ubuso bw'umubiri) ku munsi ku minsi −5, −4, na −3 na cyclophosphamide (ku gipimo cya 250 mg kuri metero kare) ku minsi −5 na −4 mbere yo guhabwa CAR T-cell.

Nyuma yo guterwa inshinge za Inaticabtagene Autoleucel, umubare w'imitsi ikoreshwa mu gupima platelet y'umurwayi wakomeje kwiyongera, kandi igisubizo cyuzuye cyarabonetse, maze imiti igabanya ubukana bw'umubiri n'indi miti yose igabanya ubudahangarwa bw'umubiri irahagarikwa. Muri iki gihe, umurwayi yasubiye mu buzima busanzwe.

Kuri ubu, hari andi magerageza menshi ya CAR-T mu Bushinwa, kandi barimo gushaka abarwayi. Kugira ngo ubone inama ku miti mishya n'ikoranabuhanga, ushobora kuvugana n'Ishami Mpuzamahanga ry'Ibitaro bya Oncology bya Beijing Region South.

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INYANDIKO Z'IBIREGO

1.http://www.juventas.cn/news.php?id=711

2.https://www.nejm.org/doi/full/10.1056/NEJMc2403743