eligibility_summary
Eligibility: Adults ≥18 with refractory autoimmune disease (SLE, immune nephritis, systemic sclerosis, dermatomyositis, neuromyelitis optica) after ≥6 months/≥2 drugs or relapse, life expectancy ≥12 weeks, lymphocytes >0.3×10^9/L, neutrophils ≥0.5×10^9/L, Hb ≥60 g/L, platelets ≥30×10^9/L, contraception ≥6 months post-infusion, consent. Exclude: neuro/serious cardiac disease, pregnancy/lactation, HIV, active HBV/HCV, renal/hepatic dysfunction, poor cell expansion, recent immunosuppressants/steroids or gene-modified cell therapy, investigator decision.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD19-BAFF–targeted CAR T-cells (autologous, gene‑modified cellular immunotherapy). Mechanism of action: Patient T cells are engineered to express a chimeric antigen receptor designed to recognize B-lineage antigens, including CD19 and targets within the BAFF (BLyS) axis, enabling T-cell activation and cytolytic depletion of pathogenic B cells/plasmablasts that drive autoimmunity. Cells/pathways targeted: CD19+ B cells, BAFF survival pathway on B cells (via BAFF receptors such as BAFF-R/TACI/BCMA), with anticipated downstream reduction of BCR-driven signaling, germinal center activity, and autoantibody production. Study: Early Phase 1, single-arm, dose-escalation in refractory autoimmune diseases.