Musi wa11 GumiguruMuna 2024, National Medical Product Administration (NMPA) yeChina yakabvumidza chikumbiro cheInvestigational New Drug (IND) cheInaticabtagene Autoleucel (CNCT19 Injection), mushonga weCD19-targetted autologous chimeric antigen receptor (CAR)-T cell therapy, kurapa Immune thrombocytopenia yesystemic lupus erythematosus (SLE - ITP). Uyu ndiwo wekutanga IND yeInaticabtagene Autoleucel yakatenderwa chirwere che autoimmune muChina.
Inaticabtagene Autoleucel chigadzirwa chekurapa nemasero eCD19 CAR-T, chine CD19 scFv（HI19a）yakasarudzika uye maitiro ekugadzira epamusoro. Inaticabtagene Autoleucel ndiyo yekutanga chigadzirwa cheCAR-T chakapihwa CD19 muChina, uye ndiyo yekutanga CAR-T cell therapy chigadzirwa cheB-ALL chakatengeswa muChina. Inaticabtagene Autoleucel iri kuwedzera kushandiswa kwayo kune zviratidzo zvakasiyana-siyana, zvinosanganisira vakuru r/r B-ALL, r/r DLBCL, vana nevechidiki r/r B-ALL, uye zvirwere zvakasiyana-siyana zve autoimmune. Itsva Drug Application (NDA) yekurapa Relapsed kana Refractory Large B-Cell Lymphoma yakagamuchirwa neNMPA munaGunyana 2024.
SLE chirwere chinokonzerwa nemuviri chinodzivirira muviri, chinowanzo kukonzera kukuvara kwenhengo dzakawanda. Masero eB asina kujairika uye maantibody anokonzera chirwere anoita basa rakakosha mukukura kweSLE. SLE inogona kukonzera kuparadzwa kwemaplatelet zvakanyanya, kureva SLE-ITP. SLE-ITP inoitika muvanhu vanosvika 16% vevarwere vekuChina vane SLE, vazhinji vevarwere veSLE-ITP vanopindura zvisina kunaka kumasteroids, ma immunoinhibitors, uye mishonga yebiological, uye vanowanzova nenjodzi huru yekubuda ropa munhengo, nepo kurarama kwavo kwenguva refu kuri kushoma.
Muna Chikunguru wegore rino, "The New England Journal of Medicine" ine mukurumbirayakaburitsa chidzidzo chinonzi "Anti-CD19 CAR T cells mu refractory immune thrombocytopenia yeSLE," chakanyorwa pamwe chete naProfessor Zeng Xiaofeng naProfessor Li Mengtao vekuRheumatology Department naProfessor Zhou Daobin vekuHematology Department yePeking Union Medical College Hospital. Chidzidzo ichi chakaratidza kushanda kwenguva refu uye kuchengetedzeka kweInaticabtagene Autoleucel mukurapa SLE-ITP, zvichiratidza kugona kukuru kweCAR-T cell therapy.
Mukadzi ane makore makumi matatu nemasere ekuberekwa akaonekwa aine chirwere cheSLE muna 2014 uye akaonekwa aine reversible proteinuria uye arthritis uye persistent thrombocytopenia. Kurapwa kwakaitwa kare ne high dose glucocorticoids (methylprednisolone pulses), hydroxychloroquine, intravenous immune globulin, tacrolimus, cyclosporin A, sirolimus, rituximab, danazol, eltrombopag, uye recombinant human thrombopoietin hakuna kuderedza thrombocytopenia. Kuwanda kwemaplatelet kwakaramba kuri pakati pe10,000 kusvika 20,000 pa cubic millimeter uye pakupedzisira kwakadzikira pasi pe10,000 pa cubic millimeter muna Chikunguru 2023.
Panguva iyoyo, akaonekwa ne purpura ne ecchymoses pamakumbo ake, ma blisters eropa remuromo, uye kubuda ropa mudumbu. Kuongororwa kwake kwebhonzo kwakaratidza active myeloproliferation uye kukanganisa kukura kwe megakaryocyte. Prednisone yakaderera (5 mg pazuva) uye hydroxychloroquine (0.2 g pazuva) chete ndiyo yakapihwa mumwedzi usati waiswa CAR T-cell infusion. Autologous fresh leukapheresis yakashandiswa kugadzira inati-cel. Huwandu hwe500,000 CD19 CAR T cells pa kilogram yehuremu hwemuviri hwakapihwa mushure mekunge murwere apihwa lymphodepleting chemotherapy ne fludarabine (pamuyero we25 mg pa square meter yenzvimbo yemuviri) pazuva pamazuva −5, −4, uye −3 uye cyclophosphamide (pamuyero we250 mg pa square meter) pamazuva −5 ne −4 CAR T-cell therapy isati yaitwa.
Mushure meInaticabtagene Autoleucel Injection, huwandu hwemaplatelet emurwere hwakaramba huchikwira, uye mhinduro yakakwana yekiriniki yakawanikwa, uye maglucocorticoids uye mishonga yese yekudzivirira muviri yakamiswa. Parizvino, murwere adzokera kuhupenyu hwake hwemazuva ese.
Parizvino, kune mimwe miedzo yakawanda yeCAR-T muChina, uye vari kutsvaga varwere. Kuti muwane mazano pamusoro pemishonga mitsva netekinoroji, munogona kubata Beijing South Region Oncology Hospital International Department.
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Email：myimmnet@163.com
ZVINOTAURWA
1.http://www.juventas.cn/news.php?id=711
2. https://www.nejm.org/doi/full/10.1056/NEJMc2403743
Nguva yekutumira: Mbudzi-08-2024