I te 11 o Oketopa, 2024, kua whakaaetia e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) te tono Rongoā Hou Rangahau（IND） mōKo te Inaticabtagene Autoleucel (CNCT19 Werohanga), he rongoā pūtau-T autologous chimeric antigen receptor (CAR)-T e arohia ana e te CD19, hei rongoā i te immunothrombocytopenia o te systemic lupus erythematosus (SLE – ITP). Koinei te IND tuatahi o te Inaticabtagene Autoleucel kua whakaaetia mō ngā mate pūnaha ārai mate i Haina.
Ko te Inaticabtagene Autoleucel he hua whakaora pūtau CD19 CAR-T, kei roto ko te CD19 scFv（HI19a） ahurei me ngā tukanga hanga matatau. Ko te Inaticabtagene Autoleucel te hua CAR-T tuatahi i ahu mai i te CD19 i Haina, me te hua whakaora pūtau CAR-T hokohoko tuatahi mō te B-ALL i Haina. Kei te whakawhānui ake a Inaticabtagene Autoleucel i tana tono mō ētahi tohu, tae atu ki te r/r B-ALL pakeke, te r/r DLBCL, te r/r B-ALL tamariki me te taiohi, me ngā mate pūnaha ārai mate. Kua whakaaetia e te NMPA tana Whakamahinga Rongoā Hou (NDA) mō te rongoā i te Lymphoma Pūtau-B Nui kua hoki whakamuri, kua ātete rānei.
He mate pūnaha ārai mate te SLE, e arahi ana ki te kino o ngā okana maha. He mahi nui tā ngā pūtau-B rerekē me ngā autoantibody i roto i te pathogenesis o te SLE. Ka taea e te SLE te whakangaro i ngā pereti toto nui rawa atu, arā, ko te SLE-ITP. Ka puta te SLE-ITP i roto i te 16% o ngā tūroro SLE Hainamana, ko te nuinga o ngā tūroro SLE-ITP he tino ngoikore te urupare ki ngā steroids, ngā immunoinhibitors, me ngā rongoā koiora, ā, he maha ngā wā ka pāngia e te mōrearea nui o te toto o ngā okana, engari he ngoikore te oranga mō te wā roa.
I te marama o Hūrae o tēnei tau, i puta te pukapuka rongonui "The New England Journal of Medicine"i whakaputa i tētahi rangahau "Ngā pūtau T CAR Anti-CD19 i roto i te thrombocytopenia ārai mate ātete o te SLE," i tuhia tahitia e Ahorangi Zeng Xiaofeng me Ahorangi Li Mengtao o te Tari Rheumatology me Ahorangi Zhou Daobin o te Tari Hematology o te Hōhipera o te Kāreti Hauora o Peking Union. I whakaatuhia e te rangahau te whai huatanga roa me te haumaru o Inaticabtagene Autoleucel ki te rongoā i te SLE-ITP, e whakaatu ana i te kaha nui o te rongoā pūtau CAR-T.
I te tau 2014, i kitea he wahine 38-tau te pakeke e pangia ana e te SLE, ā, i puta mai he pūmua toto whakahurihuri me te mate rumatiki me te thrombocytopenia pumau. Kāore i taea te whakaiti i te thrombocytopenia e ngā maimoatanga o mua me ngā glucocorticoids horopeta nui (ngā methylprednisolone pulses), hydroxychloroquine, intravenous immune globulin, tacrolimus, cyclosporin A, sirolimus, rituximab, danazol, eltrombopag, me te recombinant human thrombopoietin. I puritia te maha o ngā pereti toto ki te 10,000 ki te 20,000 ia mirimita kūpiko, ā, i te mutunga ka heke iho i raro i te 10,000 ia mirimita kūpiko i te Hōngongoi 2023.
I taua wā, i puta mai ia me te purpura me te ecchymoses i runga i ōna waewae, ngā pupuhi toto o te waha, me te toto o te kapia. I whakaatuhia e tana whakamātautau hinu wheua te myeloproliferation kaha me te ngoikore o te pakeketanga megakaryocyte. Ko te prednisone iti-hohenga anake (5 mg ia rā) me te hydroxychloroquine (0.2 g ia rā) i tukuna i te marama i mua i te werohanga pūtau-T CAR. I whakamahia te leukapheresis hou autologous hei whakaputa inati-cel. I tukuna he 500,000 CD19 CAR T pūtau ia kirokaramu o te taumaha tinana i muri i te whiwhinga o te tūroro i te chemotherapy lymphodepleting me te fludarabine (i te horopeta o te 25 mg ia mita tapawha o te mata-tinana) ia rā i ngā rā −5, −4, me te −3 me te cyclophosphamide (i te horopeta o te 250 mg ia mita tapawha) i ngā rā −5 me te −4 i mua i te rongoā pūtau-T CAR.
I muri i te Werohanga Inaticabtagene Autoleucel, ka piki haere tonu te maha o ngā pereti toto o te tūroro, ā, ka tutuki te urupare katoa haumanu, ā, ka mutu te whakamahi i ngā glucocorticoids me ngā rongoā ārai mate katoa. I tēnei wā, kua hoki te tūroro ki tōna oranga noa.
I tēnei wā, he maha atu ngā whakamātautau haumanu CAR-T i Haina, ā, kei te rapu tūroro rātou. Mō te kōrerorero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.
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NGĀ TOHUTORO
1.http://www.juventas.cn/news.php?id=711
2.https://www.nejm.org/doi/full/10.1056/NEJMc2403743
Wā tuku: Whiringa-ā-rangi-08-2024