Maganin CAR-T na BIOOCUS Medical Group Dual CD19/BCMA ya samar da sakamako mai kyau a cikin Myasthenia Gravis mai tsauri: Tafiyar Majinyaci Matashi

Myasthenia Gravis (MG) cuta ce ta jijiyoyin jiki da ke da alaƙa da garkuwar jiki ta hanyar ƙwayoyin cuta masu hana garkuwar jiki (musamman anti-acetylcholine receptor antibodies, AchRAb) waɗanda ke lalata sadarwa tsakanin jijiyoyi da tsoka, wanda ke haifar da rauni mai canzawa, ptosis, dysphagia, da kuma a cikin mawuyacin hali mai barazanar rayuwa. Ga marasa lafiya da ke da MG masu hana garkuwar jiki waɗanda ba su amsa maganin rigakafi na gargajiya ba, IVIG, FcRn inhibitors, ko complement inhibitors, zaɓuɓɓukan magani sun iyakance - har yanzu.

Maganin CD19/BCMA CAR-T na BIOOCUS Medical Group mai haɗakar matakai biyu yana wakiltar wani sabon maganin ƙwayoyin halitta na autologous wanda ke kawar da ƙwayoyin B masu cutarwa da ƙwayoyin plasma waɗanda ke da alhakin samar da ƙwayoyin rigakafi na autoantibody. Wannan hanyar da ake amfani da ita ta hanyoyi biyu tana ba da damar samun sassauci mai zurfi da dorewa ta hanyar magance ɓangarorin ƙwayoyin halitta da na humoral na amsawar autoantibody.

Wani misali ya nuna alƙawarin maganin. An gano wata majiyyaciya 'yar shekara 20, wacce aka fi sani da LYN, tana da Myasthenia Gravis mai rarrafe (CNGIIIa, AchRAb-positive) da kuma thymoma/thymic hyperplasia bayan tiyatar B3. Haka kuma tana da wasu cututtuka da suka haɗa da osteoporosis, kai na biyu na femoral da kuma left proximal tibial avascular necrosis, da kuma rashin ƙarfe. Duk da hanyoyin magani da yawa daga 2019 zuwa 2025 - gami da steroids masu yawan shan magani da azathioprine, tacrolimus, cyclosporine, maimaita IVIG, efgartigimod, eculizumab da telitaccept, da rituximab (500 mg) - yanayinta bai daidaita ba.

A watan Nuwamba na 2025, an fara amfani da tsarin CAR-T kuma an dakatar da cyclosporine. An tattara ƙwayoyin mononuclear na jini na gefe a ranar 1 ga Disamba, 2025. A ranar 15 ga Disamba, 2025, ta sami jiko na CD19 CAR-T (0.5×10⁶/kg) da BCMA CAR-T (1×10⁶/kg). Ba a ga wani mummunan abu ba bayan jiko.

Zuwa watan Maris na 2026, kimantawa na bibiya sun nuna faɗaɗawar CAR-T cikin sauri, tare da mafi girman CD19 CAR-T a rana ta 10 (7.62%, 4.622×10⁷/L) da BCMA CAR-T a rana ta 10 (17.17%, 1.0414×10⁸/L), wanda aka ci gaba har zuwa watan 3. Ingantaccen dakin gwaje-gwaje ya haɗa da raguwa mai mahimmanci a cikin matakan AchRAb da jimlar adadin B-lymphocyte, tare da daidaiton adadin jini, aikin hanta da koda. A asibiti, an sami ci gaba mai mahimmanci a cikin ƙimar Quantitative Myasthenia Gravis (QMG) da Ayyukan Rayuwa na Yau da Kullum (ADL). Alamomin kamar diplopia, taurin fuska, dysarthria, da gajiyar gaɓoɓi sun nuna mafita ko ci gaba mai kyau.

Wannan shari'ar ta nuna yuwuwar sauyi na maganin BIOOCUS Medical Group mai manufa biyu CD19/BCMA CAR-T wajen cimma sake saita garkuwar jiki mai zurfi da kuma fa'ida mai ma'ana a asibiti a cikin MG mai hana kamuwa da cuta. An jure wa maganin sosai, ba tare da an lura da CRS ko gubar jijiyoyi ba, kuma yana da alƙawarin samun gafara na dogon lokaci yayin da yake rage buƙatar hana garkuwar jiki na yau da kullun.