Thaum Lub Kaum Hli 11Xyoo 2024, Tuam Tshoj Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau pom zoo rau daim ntawv thov Tshuaj Tshiab Tshawb Fawb (IND) rauInaticabtagene Autoleucel (CNCT19 Injection), yog ib qho kev kho mob CD19-targeted autologous chimeric antigen receptor (CAR)-T cell, los kho cov kab mob Immune thrombocytopenia ntawm systemic lupus erythematosus (SLE - ITP). Qhov no yog thawj IND ntawm Inaticabtagene Autoleucel tau pom zoo rau cov kab mob autoimmune hauv Suav teb.
Inaticabtagene Autoleucel yog ib yam khoom kho mob CD19 CAR-T cell, uas muaj CD19 scFv (HI19a) tshwj xeeb thiab cov txheej txheem tsim khoom siab heev. Inaticabtagene Autoleucel yog thawj yam khoom lag luam CD19-targeted CAR-T uas tsim hauv Suav teb, thiab thawj yam khoom kho mob CAR-T cell rau B-ALL hauv Suav teb. Inaticabtagene Autoleucel tab tom nthuav nws daim ntawv thov rau ntau yam kev qhia, suav nrog cov neeg laus r/r B-ALL, r/r DLBCL, menyuam yaus thiab cov hluas r/r B-ALL, thiab ntau yam kab mob autoimmune. Nws Daim Ntawv Thov Tshuaj Tshiab (NDA) ntawm kev kho mob Relapsed lossis Refractory Large B-Cell Lymphoma tau txais los ntawm NMPA thaum lub Cuaj Hli 2024.
SLE yog ib yam kab mob autoimmune uas ua rau lub cev puas tsuaj, feem ntau ua rau ntau yam kab mob hauv lub cev puas tsuaj. Cov qe ntshav B tsis zoo thiab cov tshuaj tiv thaiv kab mob ua lub luag haujlwm tseem ceeb hauv SLE pathogenesis. SLE tuaj yeem ua rau cov platelet puas tsuaj ntau dhau, uas yog SLE-ITP. SLE-ITP tshwm sim rau kwv yees li 16% ntawm cov neeg mob SLE Suav, feem ntau ntawm cov neeg mob SLE-ITP tsis teb zoo rau cov tshuaj steroids, cov tshuaj tiv thaiv kab mob, thiab cov tshuaj biological, thiab feem ntau muaj kev pheej hmoo loj ntawm kev los ntshav hauv lub cev, thaum lawv txoj sia nyob ntev tsis zoo.
Thaum Lub Xya Hli ntawm lub xyoo no, lub koom haum muaj koob npe nrov "The New England Journal of Medicine"tau luam tawm ib txoj kev tshawb fawb "Anti-CD19 CAR T cells hauv kev tiv thaiv kab mob thrombocytopenia ntawm SLE," uas tau sau los ntawm Xibfwb Zeng Xiaofeng thiab Xibfwb Li Mengtao los ntawm Rheumatology Department thiab Xibfwb Zhou Daobin los ntawm Hematology Department ntawm Peking Union Medical College Hospital. Txoj kev tshawb fawb no tau qhia txog kev ua haujlwm ntev thiab kev nyab xeeb ntawm Inaticabtagene Autoleucel hauv kev kho SLE-ITP, qhia txog lub peev xwm loj ntawm CAR-T cell therapy.
Muaj ib tug poj niam hnub nyoog 38 xyoo tau kuaj pom tias muaj SLE xyoo 2014 thiab nws muaj proteinuria uas rov qab tau thiab mob pob qij txha thiab mob ntshav qis tas li. Cov kev kho mob yav dhau los nrog cov tshuaj glucocorticoids ntau (methylprednisolone pulses), hydroxychloroquine, tshuaj immune globulin hauv cov hlab ntsha, tacrolimus, cyclosporin A, sirolimus, rituximab, danazol, eltrombopag, thiab recombinant human thrombopoietin tsis tau pab txo qhov mob ntshav qis. Cov lej platelet tau tswj hwm ntawm 10,000 txog 20,000 ib cubic millimeter thiab thaum kawg poob qis dua 10,000 ib cubic millimeter thaum Lub Xya Hli 2023.
Lub sijhawm ntawd, nws tau muaj cov tsos mob purpura thiab ecchymoses ntawm nws ob txhais ceg, cov ntshav hauv qhov ncauj tawm, thiab cov ntshav hauv cov pos hniav. Nws cov pob txha pob txha smear qhia txog myeloproliferation thiab kev puas tsuaj ntawm megakaryocyte maturation. Tsuas yog cov tshuaj prednisone tsawg (5 mg ib hnub) thiab hydroxychloroquine (0.2 g ib hnub) tau muab rau lub hlis ua ntej CAR T-cell infusion. Autologous fresh leukapheresis tau siv los tsim inati-cel. Tag nrho ntawm 500,000 CD19 CAR T cell ib kilogram ntawm qhov hnyav ntawm lub cev tau muab tom qab tus neeg mob tau txais lymphodepleting chemotherapy nrog fludarabine (ntawm koob tshuaj ntawm 25 mg ib square meter ntawm lub cev-qhov chaw) ib hnub rau hnub −5, −4, thiab −3 thiab cyclophosphamide (ntawm koob tshuaj ntawm 250 mg ib square meter) rau hnub −5 thiab −4 ua ntej CAR T-cell therapy.
Tom qab txhaj tshuaj Inaticabtagene Autoleucel, tus neeg mob cov ntshav platelet tseem nce ntxiv, thiab kev teb tau zoo tag nrho, thiab glucocorticoids thiab txhua yam tshuaj immunosuppressants raug tso tseg. Tam sim no, tus neeg mob tau rov qab mus rau lub neej ib txwm.
Tam sim no, muaj ntau lwm yam kev sim tshuaj CAR-T hauv Suav teb, thiab lawv tab tom nrhiav cov neeg mob. Yog xav tau kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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COV LUS QHIA
1.http://www.juventas.cn/news.php?id=711
2.https://www.nejm.org/doi/full/10.1056/NEJMc2403743
Lub sijhawm tshaj tawm: Kaum Ib Hlis-08-2024