eligibility_summary
Eligibility: Adults 18–70 with generalized myasthenia gravis (MGFA II–IVa/IVb), seropositive (AChR, MuSK, LRP4) or seronegative. Exclude: contraindication to leukapheresis, severe allergy to fludarabine/cyclophosphamide, active infection, severe/uncontrolled systemic disease, investigator-deemed high risk, significant lung/cardiac impairment, prior solid-organ or hematopoietic cell transplant. Other criteria may apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
RESET-MG (NCT06359041) tests CABA-201, an autologous anti-CD19 CAR-T cell therapy (gene-modified T cells) given as a single IV infusion after lymphodepletion with cyclophosphamide (alkylating, immunosuppressive) and fludarabine (purine analog, lymphodepleting). Mechanism: CAR-T cells recognize CD19 and eradicate B-lineage cells (naive/memory B cells and plasmablasts), aiming to suppress production of pathogenic autoantibodies (AChR, MuSK, LRP4) that disrupt neuromuscular junction signaling in generalized myasthenia gravis. Targets: CD19+ B cells/plasmablasts, B-cell/autoantibody pathways driving NMJ dysfunction. Phase 1/2, open-label, single-group, includes seropositive and seronegative gMG adults.