Na Ọktoba 11, 2024, Ụlọ Ọrụ Nlekọta Ngwaahịa Ahụike Mba nke China (NMPA) akwadola ngwa maka Ọgwụ Ọhụrụ nke Investigational (IND) makaInaticabtagene Autoleucel (CNCT19 Injection), ọgwụgwọ sel T nke a na-akpọ autologous chimeric antigen receptor (CAR) nke CD19, iji gwọọ Immune thrombocytopenia nke sistemụ lupus erythematosus (SLE – ITP). Nke a bụ IND mbụ nke Inaticabtagene Autoleucel akwadoro maka ọrịa autoimmune na China.
Inaticabtagene Autoleucel bụ ngwaahịa ọgwụgwọ mkpụrụ ndụ CD19 CAR-T, nke nwere CD19 scFv（HI19a）pụrụ pụrụ iche na usoro nrụpụta dị elu. Inaticabtagene Autoleucel bụ ngwaahịa CAR-T mbụ e ji CD19 mee nke e si n'ụlọ akụpụta na China, ọ bụkwa ngwaahịa ọgwụgwọ mkpụrụ ndụ CAR-T mbụ e ji azụ ahịa maka B-ALL na China. Inaticabtagene Autoleucel na-agbasa ojiji ya maka ọtụtụ ihe ngosi, gụnyere r/r B-ALL ndị okenye, r/r DLBCL, ụmụaka na ndị ntorobịa r/r B-ALL, na ọrịa dị iche iche nke autoimmune. NMPA anabatala ojiji ọgwụ ọhụrụ ya (NDA) nke ịgwọ Lymphoma B-Cell Large Relapsed ma ọ bụ Refractory na Septemba 2024.
SLE bụ ọrịa sistemu autoimmune, nke na-ebutekarị mmebi akụkụ ahụ dị iche iche. Mkpụrụ ndụ B na-adịghị mma na autoantibody na-arụ ọrụ dị oke mkpa na mmepe nke SLE. SLE nwere ike ibute mbibi platelet gabigara ókè, ya bụ, SLE-ITP. SLE-ITP na-eme ihe dị ka 16% nke ndị ọrịa SLE na China, ọtụtụ n'ime ndị ọrịa SLE-ITP anaghị anabata steroids, immunoinhibitors, na ọgwụ ndị dị ndụ, ha na-enwekarị nnukwu ihe egwu nke ọbara ọgbụgba n'akụkụ ahụ, ebe ndụ ha ogologo oge adịghị mma.
Na Julaị nke afọ a, akwụkwọ akụkọ a ma ama bụ "The New England Journal of Medicine"bipụtara otu nnyocha "Mkpụrụ ndụ T nke na-egbochi CD19 CAR na thrombocytopenia mgbochi nke SLE," nke Prọfesọ Zeng Xiaofeng na Prọfesọ Li Mengtao sitere na Ngalaba Rheumatology na Prọfesọ Zhou Daobin sitere na Ngalaba Hematology nke Ụlọ Ọgwụ Peking Union Medical College dere. Ọmụmụ ihe ahụ gosipụtara irè na nchekwa nke Inaticabtagene Autoleucel na-adịgide adịgide n'ịgwọ SLE-ITP, na-egosipụta nnukwu ikike nke ọgwụgwọ mkpụrụ ndụ CAR-T.
Otu nwanyị dị afọ 38 nwetara nchoputa SLE na 2014 ma nwee proteinuria na-agbanwe agbanwe na ọrịa ogbu na nkwonkwo na thrombocytopenia na-adịgide adịgide. Ọgwụgwọ ndị gara aga site na iji nnukwu dose glucocorticoids (methylprednisolone pulses), hydroxychloroquine, intravenous immune globulin, tacrolimus, cyclosporin A, sirolimus, rituximab, danazol, eltrombopag, na recombinant human thrombopoietin emeghị ka thrombocytopenia belata. A nọgidere na-enwe ọnụọgụ platelet na 10,000 ruo 20,000 kwa cubic millimeter ma mesịa daa n'okpuru 10,000 kwa cubic millimeter na Julaị 2023.
N'oge ahụ, o nwere purpura na ecchymoses n'akụkụ aka ya, ọnya ọbara ọnụ, na ọbara ọgbụgba gingival. Mbelata ọkpụkpụ ya gosiri na myeloproliferation na-arụ ọrụ nke ọma na mmebi nke megakaryocyte tolite. Naanị obere dose prednisone (5 mg kwa ụbọchị) na hydroxychloroquine (0.2 g kwa ụbọchị) ka enyere n'ọnwa tupu ntinye mkpụrụ ndụ CAR T. E jiri leukapheresis ọhụrụ onwe onye mepụta inati-cel. E nyere mkpokọta mkpụrụ ndụ CD19 CAR T 500,000 kwa kilogram nke ibu ahụ mgbe onye ọrịa ahụ mechara ọgwụ chemotherapy lymphodepleting na fludarabine (na dose nke 25 mg kwa square mita nke mpaghara ahụ) kwa ụbọchị na ụbọchị −5, −4, na −3 na cyclophosphamide (na dose nke 250 mg kwa square mita) na ụbọchị −5 na −4 tupu ọgwụgwọ mkpụrụ ndụ CAR T.
Mgbe a gbasịrị ọgwụ Inaticaabtagene Autoleucel, ọnụọgụ platelet nke onye ọrịa ahụ nọgidere na-arị elu, e wee nweta nzaghachi zuru oke n'ụlọ ọgwụ, a kwụsịkwara iji glucocorticoids na ọgwụ mgbochi ahụ niile. Ugbu a, onye ọrịa ahụ alọghachila n'ọnọdụ ya.
Ugbu a, enwere ọtụtụ nnwale ụlọ ọgwụ CAR-T ndị ọzọ na China, ha na-achọkwa ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ ọhụrụ na teknụzụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
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Ntụaka
1.http://www.juventas.cn/news.php?id=711
2.https://www.nejm.org/doi/full/10.1056/NEJMc2403743
Oge ozi: Nọvemba-08-2024