eligibility_summary
Adults 18–65, consent, ECOG≤2, survival≥12w, contraception. Diseases: LN (biopsy III/IV/V ≤2y, R/R, renal criteria), AAV (new renal pauci‑immune GN or R/R), MN (aPLA2R+, high‑risk or R/R), IgG4‑RD (active or R/R). Exclude: recent gene/other trials/live vax, cancer, active/viral infection, major cardiac/CNS disease, transplant, pregnancy, bleeding/clotting, uncontrolled HTN/DM, recent steroid/CTX/B‑cell therapy, major surgery, EGPA/alveolar hemorrhage, cannot stop immunosuppressants, allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: FKC288, an autologous dual-target BCMA/CD19 chimeric antigen receptor T-cell (CAR-T) therapy made via lentiviral transduction, single IV infusion after fludarabine/cyclophosphamide lymphodepletion. Type: genetically modified cellular immunotherapy. Mechanism of action: CAR-T cells recognize and kill CD19+ B cells and BCMA (TNFRSF17)+ plasmablasts/plasma cells, depleting autoreactive B-lineage populations and reducing pathogenic autoantibodies. Cells/pathways targeted: CD19 on B cells (pre-B through memory), BCMA on long-lived plasma cells, impacts BAFF/APRIL–BCMA survival signaling and BCR-driven humoral autoimmunity. Indications: relapsed/refractory lupus nephritis, ANCA-associated vasculitis, PLA2R+ membranous nephropathy, IgG4-related disease. Design: Phase 1, single-arm, BOIN dose escalation (0.1–3.0×10^6 CAR+ T/kg). Purpose: evaluate safety/efficacy of dual BCMA/CD19 B-lineage depletion in autoimmune kidney disease.