Pa Okutobala 11Mu 2024, bungwe la National Medical Products Administration (NMPA) la ku China lavomereza pempho la Investigational New Drug (IND) laInaticabtagene Autoleucel (CNCT19 Injection), chithandizo cha maselo a autologous chimeric antigen receptor (CAR)-T chogwiritsidwa ntchito ndi CD19, chochiza matenda a chitetezo chamthupi otchedwa immunodeficiency thrombocytopenia of systemic lupus erythematosus (SLE - ITP). Iyi ndi njira yoyamba ya Inaticabtagene Autoleucel yovomerezeka ku matenda a autoimmune ku China.
Inaticabtagene Autoleucel ndi mankhwala ochizira maselo a CD19 CAR-T, omwe ali ndi CD19 scFv（HI19a）yapadera komanso njira zopangira zapamwamba. Inaticabtagene Autoleucel ndi mankhwala oyamba a CAR-T omwe amapangidwa ndi CD19 ku China, komanso mankhwala oyamba ochizira maselo a CAR-T omwe amagulitsidwa ku China. Inaticabtagene Autoleucel ikukulitsa kugwiritsa ntchito kwake pazifukwa zingapo, kuphatikizapo akuluakulu r/r B-ALL, r/r DLBCL, ana ndi achinyamata r/r B-ALL, ndi matenda osiyanasiyana odziteteza. Mankhwala Atsopano (NDA) ochizira Relapsed or Refractory Large B-Cell Lymphoma avomerezedwa ndi NMPA mu Seputembala 2024.
SLE ndi matenda odziteteza ku matenda a autoimmune, omwe nthawi zambiri amachititsa kuti ziwalo zambiri ziwonongeke. Maselo a B osazolowereka ndi ma autoantibodies amachita gawo lofunika kwambiri pakupanga matenda a SLE. SLE ingayambitse kuwonongeka kwakukulu kwa ma platelet, omwe ndi SLE-ITP. SLE-ITP imapezeka mwa odwala pafupifupi 16% aku China omwe ali ndi SLE, ambiri mwa odwala a SLE-ITP sayankha bwino ma steroids, ma immunoinhibitors, ndi mankhwala achilengedwe, ndipo nthawi zambiri amakhala pachiwopsezo chachikulu cha kutuluka magazi m'ziwalo, pomwe moyo wawo wautali ndi wochepa.
Mu Julayi chaka chino, magazini yotchuka ya "The New England Journal of Medicine" inatulutsa nkhani zambiri.adafalitsa kafukufuku wotchedwa “Anti-CD19 CAR T cells in refractory immune thrombocytopenia of SLE,” wolembedwa ndi Pulofesa Zeng Xiaofeng ndi Pulofesa Li Mengtao ochokera ku Dipatimenti ya Rheumatology ndi Pulofesa Zhou Daobin wochokera ku Dipatimenti ya Hematology ya Peking Union Medical College Hospital. Kafukufukuyu adawonetsa mphamvu ndi chitetezo cha Inaticabtagene Autoleucel chokhalitsa pochiza SLE-ITP, kuwonetsa kuthekera kwakukulu kwa chithandizo cha maselo a CAR-T.
Mayi wazaka 38 anapezeka ndi matenda a SLE mu 2014 ndipo anali ndi proteinuria yosinthika komanso nyamakazi komanso thrombocytopenia yosatha. Mankhwala omwe adapatsidwa kale ndi glucocorticoids wambiri (methylprednisolone pulses), hydroxychloroquine, intravenous immune globulin, tacrolimus, cyclosporin A, sirolimus, rituximab, danazol, eltrombopag, ndi recombinant human thrombopoietin sanachepetse thrombocytopenia. Kuchuluka kwa ma platelet kunasungidwa pa 10,000 mpaka 20,000 pa cubic millimeter ndipo pamapeto pake kunatsika pansi pa 10,000 pa cubic millimeter mu Julayi 2023.
Panthawiyo, anali ndi purpura ndi ecchymoses pa miyendo yake, matuza amagazi mkamwa, komanso kutuluka magazi m'chifuwa. Kupaka kwake kwa m'mafupa kunasonyeza kufalikira kwa myeloproliferation komanso kuwonongeka kwa kukula kwa megakaryocyte. Prednisone yochepa (5 mg patsiku) ndi hydroxychloroquine (0.2 g patsiku) ndi zomwe zinaperekedwa mwezi umodzi CAR T-cell isanalowe. Autologous fresh leukapheresis inagwiritsidwa ntchito popanga inati-cel. Maselo onse a CD19 CAR T 500,000 pa kilogalamu ya kulemera kwa thupi adaperekedwa wodwalayo atalandira lymphodepleting chemotherapy ndi fludarabine (pa mlingo wa 25 mg pa mita imodzi ya malo a thupi) patsiku pa masiku −5, −4, ndi −3 ndi cyclophosphamide (pa mlingo wa 250 mg pa mita imodzi ya lalikulu) pa masiku −5 ndi −4 CAR T-cell isanayambe kulandira chithandizo.
Pambuyo pa Inticabtagene Autoleucel Injection, kuchuluka kwa ma platelet a wodwalayo kunapitirira kukwera, ndipo kuyankha kwathunthu kuchipatala kunapezeka, ndipo ma glucocorticoids ndi ma immunosuppressants onse anasiya. Pakadali pano, wodwalayo wabwerera ku moyo wabwinobwino.
Pakadali pano, pali mayeso ena ambiri azachipatala a CAR-T ku China, ndipo akufunafuna odwala. Kuti mumve zambiri za mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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MAWU OTHANDIZA
1.http://www.juventas.cn/news.php?id=711
2.https://www.nejm.org/doi/full/10.1056/NEJMc2403743
Nthawi yotumizira: Novembala-08-2024