Ma ka lā 11 o ʻOkakopa, 2024, ua ʻāpono ka ʻAha Hoʻokele Huahana Lapaʻau Lahui o Kina (NMPA) i ka noi noi Investigational New Drug（IND）noʻO Inaticabtagene Autoleucel (CNCT19 Injection), kahi lāʻau lapaʻau CD19-targeted autologous chimeric antigen receptor (CAR)-T cell, e mālama i ka Immune thrombocytopenia o systemic lupus erythematosus (SLE - ITP). ʻO kēia ka IND mua o Inaticabtagene Autoleucel i ʻāpono ʻia no ka maʻi autoimmune ma Kina.
ʻO Inaticabtagene Autoleucel kahi huahana hoʻōla cell CD19 CAR-T, i hōʻike ʻia me kahi CD19 scFv（HI19a） kūikawā a me nā kaʻina hana holomua. ʻO Inaticabtagene Autoleucel ka huahana CAR-T i hoʻolālā ʻia no ka CD19 mua i ulu ma Kina, a ʻo ia ka huahana hoʻōla cell CAR-T mua i kūʻai ʻia no B-ALL ma Kina. Ke hoʻonui nei ʻo Inaticabtagene Autoleucel i kāna noi no kekahi mau hōʻailona, me ka pākeke r/r B-ALL, r/r DLBCL, pediatric a me ʻōpio r/r B-ALL, a me nā maʻi autoimmune like ʻole. Ua ʻae ʻia kāna New Drug Application (NDA) no ka mālama ʻana i ka Relapsed a i ʻole Refractory Large B-Cell Lymphoma e NMPA i Kepakemapa 2024.
He maʻi autoimmune systemic ka SLE, e alakaʻi pinepine ana i ka hōʻino ʻana o nā ʻōkana he nui. He kuleana koʻikoʻi ko nā cell B maʻamau ʻole a me ka autoantibody i ka pathogenesis SLE. Hiki i ka SLE ke hoʻopau nui i ka platelet, ʻo ia hoʻi ʻo SLE-ITP. Loaʻa ka SLE-ITP ma kahi o 16% o nā maʻi SLE Kina, ʻo ka hapa nui o nā maʻi SLE-ITP e pane maikaʻi ʻole i nā steroids, immunoinhibitors, a me nā lāʻau biological, a pinepine lākou e pilikia nui i ke kahe ʻana o ke koko o nā ʻōkana, ʻoiai ʻaʻole maikaʻi ko lākou ola lōʻihi.
I Iulai o kēia makahiki, ua hoʻolaha ka puke pai hanohano ʻo "The New England Journal of Medicine"ua paʻi i kahi noiʻi "Nā pūnaewele Anti-CD19 CAR T i loko o ka thrombocytopenia pale ʻole o SLE," i kākau pū ʻia e Polopeka Zeng Xiaofeng lāua ʻo Polopeka Li Mengtao mai ka ʻOihana Rheumatology a me Polopeka Zhou Daobin mai ka ʻOihana Hematology o ka Halemai ʻo Peking Union Medical College. Ua hōʻike ka noiʻi i ka pono lōʻihi a me ka palekana o Inaticabtagene Autoleucel i ka mālama ʻana i ka SLE-ITP, e hōʻike ana i ka hiki nui o ka lāʻau lapaʻau CAR-T cell.
Ua loaʻa i kahi wahine 38 makahiki kahi maʻi SLE i ka makahiki 2014 a ua hōʻike ʻia me ka proteinuria hiki ʻole ke hoʻohuli ʻia a me ka arthritis a me ka thrombocytopenia mau loa. ʻAʻole i hōʻoluʻolu nā lāʻau lapaʻau ma mua me nā glucocorticoids kiʻekiʻe (methylprednisolone pulses), hydroxychloroquine, intravenous immune globulin, tacrolimus, cyclosporin A, sirolimus, rituximab, danazol, eltrombopag, a me ka recombinant human thrombopoietin i ka thrombocytopenia. Ua mālama ʻia ka helu platelet ma 10,000 a 20,000 no ka cubic millimeter a ma hope ua hāʻule ma lalo o 10,000 no ka cubic millimeter i Iulai 2023.
I kēlā manawa, ua hōʻike ʻo ia me ka purpura a me nā ecchymoses ma kona mau lālā, nā pehu koko waha, a me ke kahe ʻana o ke koko gingival. Ua hōʻike kāna smear iwi iwi i ka myeloproliferation ikaika a me ka hōʻino ʻana o ka megakaryocyte maturation. ʻO ka prednisone haʻahaʻa wale nō (5 mg i kēlā me kēia lā) a me ka hydroxychloroquine (0.2 g i kēlā me kēia lā) i lawelawe ʻia i ka mahina ma mua o ka hoʻokomo ʻana o CAR T-cell. Ua hoʻohana ʻia ka leukapheresis hou autologous e hana i ka inati-cel. He 500,000 CD19 CAR T cells no ke kilokani o ke kaumaha o ke kino i lawelawe ʻia ma hope o ka hana ʻana o ka mea maʻi i ka chemotherapy lymphodepleting me fludarabine (ma kahi mahele o 25 mg no ka mika kuea o ka ʻili o ke kino) i kēlā me kēia lā ma nā lā −5, −4, a me −3 a me cyclophosphamide (ma kahi mahele o 250 mg no ka mika kuea) ma nā lā −5 a me −4 ma mua o ka lāʻau lapaʻau CAR T-cell.
Ma hope o ka hoʻokomo ʻana o Inaticabtagene Autoleucel, ua hoʻomau ka piʻi ʻana o ka helu platelet o ka mea maʻi, a ua hoʻokō ʻia ka pane piha o ke kauka, a ua hoʻopau ʻia nā glucocorticoids a me nā immunosuppressants āpau. I kēia manawa, ua hoʻi hou ka mea maʻi i ke ola maʻamau.
I kēia manawa, nui nā hoʻokolohua lapaʻau CAR-T ʻē aʻe ma Kina, a ke ʻimi nei lākou i nā maʻi. No ke kūkākūkā ʻana i nā lāʻau lapaʻau hou a me nā ʻenehana, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu kelepona：4008803716
Email：myimmnet@163.com
NĀ KUHIKUHI
1.http://www.juventas.cn/news.php?id=711
2.https://www.nejm.org/doi/full/10.1056/NEJMc2403743
Ka manawa hoʻouna: Nov-08-2024