eligibility_summary
Eligible: adults 18–65 with refractory NMOSD, expected survival ≥12 weeks, agree to effective contraception during treatment and 1 year after, and provide informed consent. Exclude: prior solid organ transplant, cancer in past 2 years, active HBV/HCV, HIV+, CMV DNA+, syphilis+, primary immunodeficiency, severe heart disease, psychiatric disorder or psychotropic abuse without withdrawal, severe allergies, pregnancy or breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 1, open‑label, dose‑escalation study in refractory AQP4‑IgG+ NMOSD testing Universal BCMA‑CD19 CAR‑T cells (BRL‑302), an allogeneic, gene‑engineered T‑cell therapy given at 1.0–4.0 x 10^6 CD3+CAR+ cells/kg. Mechanism: CAR‑T cells target two B‑lineage antigens—BCMA (TNFRSF17) on plasmablasts/plasma cells and CD19 on B cells—to deplete autoreactive B cells and long‑lived plasma cells that produce pathogenic AQP4 autoantibodies. Targeted cells/pathways: CD19+ B cells and BCMA+ plasma cells, suppression of B‑cell maturation/survival (APRIL/BAFF‑BCMA signaling) and humoral autoimmunity driving NMOSD, aiming to reduce AQP4‑IgG and downstream inflammatory injury.