Chithandizo cha BIOOCUS Medical Group cha Dual CD19/BCMA CAR-T Chimapereka Zotsatira Zabwino mu Refractory Myasthenia Gravis: Ulendo wa Wodwala Wachinyamata
Myasthenia Gravis (MG) ndi matenda osatha a autoimmune neuromuscular omwe amayamba chifukwa cha ma autoantibodies (makamaka ma anti-acetylcholine receptor antibodies, AchRAb) omwe amasokoneza kulumikizana kwa mitsempha ndi minofu, zomwe zimapangitsa kuti kufooka kusinthe, ptosis, dysphagia, komanso nthawi zina zomwe zimaika moyo pachiswe. Kwa odwala omwe ali ndi MG yokana yomwe sanayankhe mankhwala oletsa chitetezo chamthupi, IVIG, FcRn inhibitors, kapena ma complement inhibitors, njira zamankhwala zakhala zochepa - mpaka pano.
Chithandizo cha BIOOCUS Medical Group cha CD19/BCMA CAR-T chokhala ndi zolinga ziwiri chikuyimira chithandizo chapamwamba cha maselo a autologous chomwe chimachotsa maselo a B omwe ali ndi matenda komanso maselo a plasma omwe amachititsa kupanga ma antibodies a autoimmune. Njira iyi ya zolinga ziwiri imapereka mwayi woti maselo azitha kuchira bwino komanso molimba pothana ndi zinthu zomwe zimayambitsa chitetezo chamthupi komanso cha thupi.
Nkhani yofanana ikuwonetsa lonjezo la chithandizochi. Wodwala wamkazi wazaka 20, wotchedwa LYN, adapezeka ndi matenda a Myasthenia Gravis (CNGIIIa, AchRAb-positive) komanso matenda a B3-type thymoma/thymic hyperplasia pambuyo pa opaleshoni. Analinso ndi matenda ena monga osteoporosis, mutu wa m'chiuno ndi kumanzere kwa tibial avascular necrosis, komanso kuchepa kwa magazi m'thupi. Ngakhale kuti adalandira mankhwala osiyanasiyana kuyambira 2019 mpaka 2025—kuphatikizapo mankhwala a steroid okhala ndi mlingo waukulu komanso azathioprine, tacrolimus, cyclosporine, IVIG yobwerezabwereza, efgartigimod, eculizumab komanso telitacicept, ndi rituximab (500 mg)—vuto lake silinalamuliridwe.
Mu Novembala 2025, njira ya CAR-T idayambitsidwa ndipo cyclosporine idayimitsidwa. Maselo a mononuclear a m'magazi ozungulira adasonkhanitsidwa pa Disembala 1, 2025. Pa Disembala 15, 2025, adalandira chithandizo cha CD19 CAR-T (0.5×10⁶/kg) kuphatikiza BCMA CAR-T (1×10⁶/kg). Palibe zovuta zomwe zidawonedwa pambuyo pothandizidwa.
Pofika mu Marichi 2026, kuwunika kotsatira kunawonetsa kukula kwachangu kwa CAR-T mkati mwa moyo, ndi kuchuluka kwa CD19 CAR-T pa tsiku la 10 (7.62%, 4.622×10⁷/L) ndi BCMA CAR-T pa tsiku la 10 (17.17%, 1.0414×10⁸/L), komwe kunapitilira mwezi wachitatu. Kusintha kwa labotale kunaphatikizapo kuchepa kwakukulu kwa kuchuluka kwa AchRAb ndi kuchuluka kwa B-lymphocyte, ndi kuchuluka kwa magazi kokhazikika, ntchito ya chiwindi ndi impso. Mwachipatala, kuwonjezeka kodziwika bwino kunalembedwa mu Quantitative Myasthenia Gravis (QMG) ndi Activities of Daily Living (ADL). Zizindikiro monga diplopia, kuuma kwa nkhope, dysarthria, ndi kutopa kwa miyendo zinawonetsa kusintha kwakukulu kapena kusintha kwakukulu.
Nkhaniyi ikuwonetsa kuthekera kosintha kwa chithandizo cha BIOOCUS Medical Group cha CD19/BCMA CAR-T chogwiritsidwa ntchito ndi anthu awiri pothandiza kuti chitetezo chamthupi chibwererenso m'thupi komanso kuti chikhale ndi phindu lalikulu pa matenda a MG. Chithandizochi chimaloledwa bwino, popanda CRS kapena poizoni wa mitsempha, ndipo chili ndi lonjezo loti munthu azitha kuchira nthawi yayitali komanso kuchepetsa kufunika kwa kuponderezedwa kwa chitetezo chamthupi kosatha.