BIOOCUS Medical Group's Dual CD19/BCMA CAR-T Therapy Muab Cov Txiaj Ntsig Zoo Hauv Refractory Myasthenia Gravis: Ib Tug Neeg Mob Hluas Txoj Kev Mus Los
Myasthenia Gravis (MG) yog ib qho mob autoimmune neuromuscular disorder uas tshwm sim los ntawm autoantibodies (feem ntau yog anti-acetylcholine receptor antibodies, AchRAb) uas ua rau kev sib txuas lus ntawm cov hlab ntsha thiab cov leeg tsis zoo, ua rau tsis muaj zog, mob pob qij txha, ua tsis taus pa, thiab thaum mob hnyav ua rau ua tsis taus pa. Rau cov neeg mob uas muaj MG uas tsis kho tau thiab tsis tau teb rau cov tshuaj immunosuppressants, IVIG, FcRn inhibitors, lossis complement inhibitors, cov kev kho mob tau txwv - txog rau tam sim no.
BIOOCUS Medical Group txoj kev kho mob CD19/BCMA CAR-T uas siv ob lub hom phiaj yog kev kho mob hlwb autologous uas tshem tawm cov hlwb B thiab cov hlwb plasma uas ua rau muaj cov tshuaj tiv thaiv kab mob autoantibody. Txoj kev kho mob hlwb ob lub hom phiaj no muab lub peev xwm rau kev zam txim tob thiab ruaj khov los ntawm kev daws teeb meem ntawm cov hlwb thiab cov tshuaj tiv thaiv kab mob autoimmune.
Ib rooj plaub sawv cev qhia txog qhov kev cog lus ntawm kev kho mob. Ib tug poj niam mob hnub nyoog 20 xyoo, hu ua LYN, tau kuaj pom tias muaj tus kab mob Myasthenia Gravis (CNGIIIa, AchRAb-positive) thiab B3-type thymoma/thymic hyperplasia tom qab phais. Nws kuj muaj cov kab mob sib koom ua ke suav nrog osteoporosis, bilateral femoral head thiab sab laug proximal tibial avascular necrosis, thiab iron-deficiency anemia. Txawm hais tias muaj ntau txoj kev kho mob txij li xyoo 2019 txog 2025—xws li cov tshuaj steroids ntau ntxiv rau azathioprine, tacrolimus, cyclosporine, rov ua IVIG, efgartigimod, eculizumab ntxiv rau telitacicept, thiab rituximab (500 mg)—nws tus mob tseem tsis tau tswj hwm.
Thaum Lub Kaum Ib Hlis 2025, cov txheej txheem CAR-T tau pib thiab cyclosporine tau raug ncua. Cov qe ntshav mononuclear peripheral tau sau rau lub Kaum Ob Hlis 1, 2025. Thaum Lub Kaum Ob Hlis 15, 2025, nws tau txais kev txhaj tshuaj ntawm CD19 CAR-T (0.5 × 10⁶ / kg) ntxiv rau BCMA CAR-T (1 × 10⁶ / kg). Tsis muaj cov xwm txheej tsis zoo tau pom tom qab kev txhaj tshuaj.
Txog rau lub Peb Hlis 2026, kev ntsuam xyuas tom qab tau qhia txog kev nthuav dav sai sai hauv lub cev CAR-T, nrog rau qhov siab tshaj plaws CD19 CAR-T thaum hnub 10 (7.62%, 4.622 × 10⁷ / L) thiab BCMA CAR-T thaum hnub 10 (17.17%, 1.0414 × 10⁸ / L), txuas ntxiv mus txog lub hlis 3. Kev txhim kho hauv chav kuaj suav nrog kev txo qis ntawm AchRAb thiab tag nrho cov lej B-lymphocyte, nrog rau cov lej ntshav ruaj khov, kev ua haujlwm ntawm lub siab thiab lub raum. Hauv kev kho mob, cov txiaj ntsig tseem ceeb tau sau tseg hauv Quantitative Myasthenia Gravis (QMG) thiab Cov Haujlwm ntawm Kev Ua Neej Txhua Hnub (ADL) cov qhab nia. Cov tsos mob xws li diplopia, lub ntsej muag tawv, dysarthria, thiab ceg qaug zog tau qhia txog kev daws teeb meem lossis kev txhim kho tseem ceeb.
Cov ntaub ntawv no qhia txog lub peev xwm hloov pauv ntawm BIOOCUS Medical Group txoj kev kho mob CD19/BCMA CAR-T ob lub hom phiaj hauv kev ua tiav kev rov qab kho lub cev tiv thaiv kab mob thiab cov txiaj ntsig kho mob tseem ceeb hauv MG uas tsis kho tau. Kev kho mob no tau ua tiav zoo, tsis muaj CRS lossis neurotoxicity pom, thiab muaj kev cia siab rau kev zam txim mus sij hawm ntev thaum txo qhov xav tau kev tiv thaiv kab mob mus sij hawm ntev.