A ranar 11 ga Oktoba, 2024, Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta amince da aikace-aikacen Sabbin Magunguna na Bincike (IND) donInaticaabtagene Autoleucel (Alluran CNCT19), wani maganin CD19 mai ɗauke da sinadarin antigen receptor (CAR)-T cell, wanda aka yi niyya don magance cutar thrombocytopenia ta garkuwar jiki ta tsarin lupus erythematosus (SLE – ITP). Wannan shine IND na farko na Inaticaabtagene Autoleucel da aka amince da shi don magance cutar autoimmune a China.
Inaticabtagene Autoleucel samfurin maganin ƙwayoyin halitta na CD19 CAR-T ne, wanda aka nuna shi da CD19 scFv（HI19a） na musamman da kuma ci gaba da kera su. Inaticabtagene Autoleucel shine samfurin CAR-T na farko na mallakar CD19 da aka noma a gida a China, kuma shine samfurin maganin ƙwayoyin halitta na CAR-T na farko da aka sayar don B-ALL a China. Inaticabtagene Autoleucel yana faɗaɗa aikace-aikacensa don alamu da yawa, ciki har da r/r B-ALL na manya, r/r DLBCL, r/r na yara da matasa B-ALL, da cututtuka daban-daban na garkuwar jiki. NMPA ta amince da amfani da sabon magani (NDA) na magance cutar Lymphoma mai lanƙwasa ko mai hana kamuwa da cutar.
SLE cuta ce ta garkuwar jiki ta jiki, wadda yawanci ke haifar da lalacewar gabobin jiki da yawa. Kwayoyin B marasa kyau da kuma kwayoyin halittar jiki masu kashe ƙwayoyin cuta suna taka muhimmiyar rawa wajen haifar da cutar SLE. SLE na iya haifar da lalacewar platelets da yawa, wato SLE-ITP. SLE-ITP yana faruwa a kusan kashi 16% na marasa lafiyar SLE na ƙasar Sin, yawancin marasa lafiyar SLE-ITP ba sa mayar da martani sosai ga steroids, immunoinhibitors, da magungunan halittu, kuma galibi suna fuskantar babban haɗarin zubar jini a gabobin jiki, yayin da rayuwarsu ta dogon lokaci ba ta da kyau.
A watan Yuli na wannan shekarar, shahararren "The New England Journal of Medicine" ya rubutaAn buga wani bincike mai taken "Kwayoyin T na Anti-CD19 CAR a cikin cututtukan thrombocytopenia na SLE," wanda Farfesa Zeng Xiaofeng da Farfesa Li Mengtao suka rubuta tare da Farfesa Zhou Daobin daga Sashen Kula da Cututtukan Jini na Asibitin Kwalejin Kiwon Lafiya na Peking Union. Binciken ya nuna inganci da amincin Inaticaabtagene Autoleucel mai ɗorewa wajen magance SLE-ITP, yana nuna babban yuwuwar maganin ƙwayoyin CAR-T.
Wata mace 'yar shekara 38 ta sami ganewar cutar SLE a shekarar 2014 kuma ta kamu da cutar proteinuria mai jurewa da amosanin gabbai da kuma thrombocytopenia mai ɗorewa. Magungunan da aka yi a baya da glucocorticoids masu yawan gaske (methylprednisolone pulses), hydroxychloroquine, intravenous immune globulin, tacrolimus, cyclosporin A, sirolimus, rituximab, danazol, eltrombopag, da kuma recombinant human thrombopoietin ba su rage yawan thrombocytopenia ba. An ci gaba da kiyaye adadin platelets daga 10,000 zuwa 20,000 a kowace cubic millimeter kuma daga ƙarshe ya faɗi ƙasa da 10,000 a kowace cubic millimeter a watan Yulin 2023.
A wancan lokacin, ta sami purpura da ecchymoses a gaɓoɓinta, ƙurajen jini na baki, da kuma zubar jini a cikin ƙashi. Smear ɗin ƙashi nata ya nuna cewa myeloproliferation yana aiki da kuma raguwar balaga na megakaryocyte. An ba da prednisone mai ƙarancin allurai (5 mg kowace rana) da hydroxychloroquine (0.2 g kowace rana) a cikin watan kafin a yi amfani da ƙwayoyin CAR T. An yi amfani da leukapheresis mai sauƙi don samar da inati-cel. An ba da jimillar ƙwayoyin CD19 CAR T guda 500,000 a kowace kilogiram na nauyin jiki bayan da majiyyacin ya yi amfani da maganin lymphodepleting chemotherapy tare da fludarabine (a kashi 25 mg kowace murabba'in mita na yankin jiki) kowace rana a ranakun −5, −4, da −3 da cyclophosphamide (a kashi 250 mg kowace murabba'in mita) a ranakun −5 da −4 kafin a yi amfani da ƙwayoyin CAR T.
Bayan allurar Inaticaabtagene Autoleucel, adadin platelets na majiyyaci ya ci gaba da ƙaruwa, kuma an sami cikakkiyar amsa a asibiti, kuma an daina amfani da glucocorticoids da duk magungunan rage radadi. A halin yanzu, majiyyacin ya dawo cikin rayuwarsa ta yau da kullun.
A halin yanzu, akwai wasu gwaje-gwajen asibiti da yawa na CAR-T a China, kuma suna neman marasa lafiya. Don neman shawara kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Kasa da Kasa na Asibitin Oncology na Yankin Kudu na Beijing.
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NAZARI
1.http://www.juventas.cn/news.php?id=711
2.https://www.nejm.org/doi/full/10.1056/NEJMc2403743
Lokacin Saƙo: Nuwamba-08-2024