eligibility_summary
Adults ≥18 with refractory generalized MG (Class IIa–IVb), MG‑ADL ≥5 with <50% ocular, positive MG antibodies, poor response to standard therapy, stable steroids ≤20 mg/d, adequate labs/organ function, life expectancy ≥3 mo, contraception, venous access. Exclude severe allergy or F/C contraindication, significant heart disease, uncontrolled infection/CNS disease/active cancer, HIV/HBV/HCV/syphilis, recent IS/biologics/IVIG/PE/live vaccine/surgery/other trials, thymectomy <12 mo, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: GC012F injection, an autologous dual‑target chimeric antigen receptor T‑cell (CAR‑T) therapy directed at CD19 and BCMA. Mechanism: Patient T cells are engineered to recognize CD19 on B cells and BCMA on plasmablasts/plasma cells, leading to targeted cytolysis and broad B‑cell/plasma‑cell depletion, thereby suppressing pathogenic autoantibody production (e.g., anti‑AChR, MuSK, LRP4) that drives gMG. Targeted cells/pathways: CD19+ B cells, BCMA+ plasmablasts/plasma cells, humoral/autoantibody pathway. Pre‑infusion lymphodepletion with fludarabine (purine analog) and cyclophosphamide (alkylator) is planned to support CAR‑T expansion. Design: single‑arm, open‑label, early exploratory trial in refractory generalized MG, status withdrawn before enrollment.