eligibility_summary
Adults 18–65 with CD19+ B cells, adequate marrow, liver ≤3×ULN, CrCl≥60, INR/PT<1.5×ULN, contraception/neg HCG. Eligible: active SLE (SLEDAI>6+BILAG A/B), pSS‑TP (<30×10^9/L), SSc‑ILD (prog/refractory), IM (MMT‑8<142), ANCA‑AAV (BVAS≥15), APS (aPL+). Refractory/relapse to standard therapy required. Exclude severe allergy, active infection, major heart disease, Ig deficiency, cancer, ESRD, HBV/HCV/HIV/syphilis+, severe mental illness, recent trials, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: BRL-301, an allogeneic (off-the-shelf) anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, delivered as a single infusion after lymphodepleting chemotherapy. Mechanism: gene-engineered T cells express a CAR recognizing CD19 and kill CD19+ B cells via cytotoxicity, inducing deep B-cell depletion (B-cell aplasia) and an immune reset that reduces pathogenic autoantibody production. Targets: CD19+ B-cell lineage (naive/memory B cells and plasmablasts). Pathways affected: B-cell/BCR and autoantibody axis across SLE, Sjogren’s, systemic sclerosis, inflammatory myopathy, ANCA-associated vasculitis, and antiphospholipid syndrome.