Ngomhla we-11 kweyeDwarhaNgo-2024, i-National Medical Product Administration (NMPA) yaseTshayina ivumile isicelo se-Investigational New Drug (IND) se-I-Inaticabtagene Autoleucel (CNCT19 Injection), unyango lweeseli ze-antigen receptor (CAR)-T olujoliswe kwi-CD19, ukunyanga i-Immune thrombocytopenia ye-systemic lupus erythematosus (SLE - ITP). Le yi-IND yokuqala ye-Inaticabtagene Autoleucel evunyiweyo kwisifo se-autoimmune eTshayina.
I-Inaticabtagene Autoleucel yimveliso yonyango lweeseli ze-CD19 CAR-T, equlathe i-CD19 scFv（HI19a）eyahlukileyo kunye neenkqubo zokuvelisa eziphambili. I-Inaticabtagene Autoleucel yimveliso yokuqala ye-CAR-T ejoliswe kwi-CD19 ekhuliswe ekhaya eTshayina, kwaye yimveliso yokuqala yonyango lweeseli ze-CAR-T ethengiswayo ye-B-ALL eTshayina. I-Inaticabtagene Autoleucel yandisa ukusetyenziswa kwayo kwiimpawu ezahlukeneyo, kubandakanya i-r/r B-ALL yabantu abadala, i-r/r DLBCL, abantwana kunye nabakwishumi elivisayo i-r/r B-ALL, kunye nezifo ezahlukeneyo zokuzikhusela komzimba. Isicelo sayo esitsha seyeza (NDA) sokunyanga i-Relapsed okanye i-Refractory Large B-Cell Lymphoma samkelwe yi-NMPA ngoSeptemba 2024.
I-SLE sisifo esihlasela amasosha omzimba, esidla ngokukhokelela ekonakaleni kwamalungu amaninzi. Iiseli ze-B ezingaqhelekanga kunye ne-autoantibody zidlala indima ebalulekileyo kwi-SLE pathogenesis. I-SLE inokubangela ukutshatyalaliswa okukhulu kweeplatelet, oko kukuthi i-SLE-ITP. I-SLE-ITP yenzeka malunga ne-16% yezigulane zaseTshayina ze-SLE, uninzi lwezigulane ze-SLE-ITP aziphenduli kakuhle kwii-steroids, ii-immunoinhibitors, kunye namayeza ebhayoloji, kwaye zihlala zisengozini enkulu yokopha amalungu, ngelixa ukusinda kwazo ixesha elide kuphantsi kakhulu.
NgoJulayi walo nyaka, iphephancwadi elidumileyo elithi "The New England Journal of Medicine"ipapashe uphando oluthi “Anti-CD19 CAR T cells in refractory immune thrombocytopenia of SLE,” olubhalwe nguNjingalwazi uZeng Xiaofeng kunye noNjingalwazi uLi Mengtao abavela kwiSebe leRheumatology kunye noNjingalwazi uZhou Daobin ovela kwiSebe leHematology lePeking Union Medical College Hospital. Olu phononongo lubonise ukusebenza kakuhle nokukhuseleka kwe-Inaticabtagene Autoleucel ekunyangeni i-SLE-ITP, lugxininisa amandla amakhulu onyango lweeseli ze-CAR-T.
Ibhinqa elineminyaka engama-38 ubudala lafunyaniswa line-SLE ngo-2014 laza lafumana i-reversible proteinuria kunye ne-arthritis kunye ne-persistent thrombocytopenia. Unyango lwangaphambili olusebenzisa i-glucocorticoids ephezulu (i-methylprednisolone pulses), i-hydroxychloroquine, i-intravenous immune globulin, i-tacrolimus, i-cyclosporin A, i-sirolimus, i-rituximab, i-danazol, i-elthrombopag, kunye ne-recombinant human thrombopoietin aluzange luyithomalalise i-thrombocytopenia. Amanani eeplatelet agcinwe kwi-10,000 ukuya kwi-20,000 nge-cubic millimeter nganye kwaye ekugqibeleni ehla ngaphantsi kwe-10,000 nge-cubic millimeter nganye ngoJulayi 2023.
Ngelo xesha, wayene-purpura kunye ne-ecchymoses emilenzeni yakhe, ama-blisters egazi emlonyeni, kunye nokopha kwegazi esiswini. I-bone marrow smear yakhe yabonisa i-myeloproliferation esebenzayo kunye nokuphazamiseka kokuvuthwa kwe-megakaryocyte. I-prednisone enedosi ephantsi kuphela (5 mg ngosuku) kunye ne-hydroxychloroquine (0.2 g ngosuku) zanikwa kwinyanga engaphambi kokufakwa kwe-CAR T-cell. I-Autologous fresh leukapheresis yasetyenziswa ukuvelisa i-inati-cel. Iiseli ze-CD19 CAR T ezingama-500,000 ngekhilogram yobunzima bomzimba zanikwa emva kokuba isigulane sifumene i-lymphodepleting chemotherapy nge-fludarabine (ngedosi ye-25 mg ngemitha yesikwere yendawo yomzimba) ngosuku ngeentsuku ze-−5, −4, kunye ne-−3 kunye ne-cyclophosphamide (ngedosi ye-250 mg ngemitha yesikwere) ngeentsuku ze-−5 kunye ne-−4 ngaphambi konyango lwe-CAR T-cell.
Emva kwe-Inaticabtagene Autoleucel Injection, inani leeplatelet zesigulana laqhubeka linyuka, kwaye impendulo epheleleyo yeklinikhi yafunyanwa, kwaye ii-glucocorticoids kunye nazo zonke ii-immunosuppressants zayekiswa. Okwangoku, isigulana sibuyele kubomi obuqhelekileyo.
Okwangoku, kukho ezinye iimvavanyo ezininzi zeklinikhi ze-CAR-T eTshayina, kwaye zikhangela izigulane. Ukuze ufumane iingcebiso ngamayeza amatsha kunye netekhnoloji, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
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IIREFERENSI
1.http://www.juventas.cn/news.php?id=711
2.https://www.nejm.org/doi/full/10.1056/NEJMc2403743
Ixesha leposi: Novemba-08-2024