eligibility_summary
Eligibility: Adults 18–65, ≥45 kg, consented, using contraception, confirmed SLE, Sjögren’s, inflammatory myopathy, systemic sclerosis, Behçet’s, ANCA‑vasculitis, IgG4‑RD, APS, or aTTP, refractory to prior therapy, on stable ≤1 mg/kg/d steroids/DMARDs ≥4 wks, meet disease‑specific activity criteria. Exclude: recent rituximab/high‑dose steroids, serious organ failure/comorbidity, IL‑2 allergy, serious/active infections (incl. TB/HIV/HCV), recent cancer, live vaccines/BCG, pregnancy, psych/substance issues, plus myositis and anti‑GBM AAV exclusions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: BCMA-CD19 CAR-T therapy—autologous, gene-modified chimeric antigen receptor T cells, single IV infusion (3×10^6 CAR+ cells/kg) after preconditioning. Mechanism: dual-targeted CARs redirect T-cell cytotoxicity to deplete CD19+ B cells and BCMA (TNFRSF17)+ plasmablasts/long-lived plasma cells, aiming to eliminate autoreactive B-lineage cells, suppress autoantibody production, and reduce B cell–driven inflammation. Cells/pathways targeted: B cells, plasmablasts, plasma cells, antigens CD19 and BCMA, humoral autoimmunity pathways including BCR signaling and the BAFF/APRIL–BCMA survival axis. Indications: refractory SLE, inflammatory myopathy, systemic sclerosis, ANCA vasculitis, IgG4-RD, APS, TTP, Behçet, Sjögren. Design: open-label, single-arm, primary endpoints—complete remission and labs, secondary—PK, durability, safety.