eligibility_summary
Adults 18–80 with systemic antibody‑positive refractory MG (failed ≥2 immunosuppressants and/or need PE/IVIg), MGFA IIa–IVa, QMGS ≥11 or MG‑ADL ≥5 (ocular ≤50%), consent, contraception required (WOCBP negative tests). Exclude: pregnancy/lactation, active infection, thymectomy <6 mo/planned, unresected thymoma/chemo‑RT, live vaccine ±8 wks, RTX <6 mo, Tcz/Ecu <3 mo, IVIg/PE/other IS <4 wks, major comorbidity/lab abnl, TB/HIV/HBsAg+, transfusion <4 wks, MG crisis IVb–V, poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06371040 (Phase 1, single-center, open-label, dose-escalation) in refractory generalized myasthenia gravis. Intervention: CD19-BCMA dual-target CAR-T—an autologous, gene-modified adoptive T-cell therapy. Mechanism of action: patient T cells are engineered with chimeric antigen receptors to recognize CD19 and BCMA, leading to cytotoxic elimination of CD19+ B cells and BCMA+ plasmablasts/plasma cells, aiming to deplete autoantibody-producing compartments and suppress humoral autoimmunity. Targets/cells/pathways: mature and memory B cells (CD19), plasmablasts/plasma cells (BCMA), the B-cell/antibody production axis driving AChR/MuSK/LRP4 autoantibodies. Dosing: 5e5, 1.5e6, or 5e6 CAR-T positive cells/kg to define the MTD and assess preliminary efficacy.