eligibility_summary
Eligible: adults 18-65 with lupus nephritis, prior inadequate response, active class III/IV +/- V (ISN/RPS 2018), NIH activity >2 with chronicity, UPCR >=1 g/g or 24-h protein >=1 g +/- active sediment, on steroids +/- antimalarials, SLEDAI-2K >=6, ANA/anti-dsDNA/anti-Sm+, CD19+ B cells, uses effective contraception, consent. Exclude: transplant, recent cancer, active HBV/HCV/HIV/CMV/syphilis, immunodeficiency, severe heart disease, psych illness/drug abuse, severe allergy, pregnant/lactating.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Early-phase, single-arm study in refractory lupus nephritis testing universal (allogeneic) CAR-T cells targeting BCMA and CD19. Intervention/type: Biological, gene‑modified T-cell therapy, two CAR-T products administered in combination (BCMA CAR-T + CD19 CAR-T). Mechanisms of action: CAR-T cells engage BCMA (TNFRSF17) to ablate plasmablasts/long‑lived plasma cells and engage CD19 to deplete naïve, memory, and activated B cells. Cytotoxic CAR signaling eliminates antigen-expressing cells, aiming to suppress autoantibody production and reset humoral immunity. Targeted cells/pathways: CD19+ B-lineage cells and BCMA+ plasmablasts/plasma cells, downstream reduction of autoantibodies/immune complexes central to SLE/LN pathogenesis.