eligibility_summary
Adults 18–70 with active SLE (EULAR/ACR≥10, SELENA‑SLEDAI≥8), CD19+ B cells, organ involvement, adequate counts (Hgb≥85, WBC≥2.5, ANC≥1, PLT≥50), organ function (AST/ALT<2×ULN, CrCl≥30, bili≤2.0, EF≥50%), venous access, consent/follow‑up, women: neg test + contraception 1y. Exclude severe nephritis/dialysis, CNS/major organ disease, immunodef./inf., ulcers, recent IS, live vaccine, HIV/HBV/HCV/syphilis, prior CD19/BCMA, recent surgery/trial, pregnancy, allergy, Cy/Flu contraind., PI judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05846347 (Phase I, single-arm) tests GC012F injection—an autologous, dual-target CAR-T cell therapy. Drug/intervention: GC012F (CD19-BCMA CAR-T cells), a gene-modified T‑cell therapy infused IV once. Mechanism of action: CAR-engineered T cells recognize CD19 and BCMA to selectively kill B-lineage cells and plasma cells, depleting autoreactive B cells/plasmablasts and long‑lived antibody-secreting cells, aiming to reset humoral immunity and reduce autoantibody-driven pathology. Targets: CD19+ B cells/plasmablasts, BCMA+ plasma cells. Pathways affected: humoral autoimmunity (autoantibody production), B-cell antigen presentation to T cells, inflammatory cytokine cascade, BCMA (APRIL/BAFF) survival signaling in plasma cells.