eligibility_summary
Adults 18–70 with SLE (2019 EULAR/ACR), CD19+ B cells, SLEDAI≥8 (clinical≥4 if serology), positive ANA/dsDNA/Sm, failed ≥6 mo standard+biologic therapy, adequate organ function, and contraception. Exclude prior CD19/BCMA/CAR‑T, CD20 ≤6 mo, recent high-dose steroids/immunosuppressants, serious cardiac/renal/pulmonary/CNS disease, uncontrolled HTN, bleeding/thrombosis, recent cancer, active infection or HIV/HBV/HCV/syphilis+, recent live vaccine/surgery/other trials, severe allergy or Flu‑Cy contraindication, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06530849: Phase 1/2, single-arm, open-label study in refractory SLE testing GC012F Injection, an autologous chimeric antigen receptor (CAR) T‑cell therapy that dual-targets BCMA (B‑cell maturation antigen) and CD19. Mechanism: patient T cells are engineered to recognize and kill CD19+ B cells and BCMA+ plasmablasts/long‑lived plasma cells, depleting autoreactive B-lineage compartments, reducing pathogenic autoantibodies, and aiming to reset humoral immunity. Targets: CD19+ B cells, BCMA+ plasma cells, key pathways include BCR-driven responses and BAFF/APRIL–BCMA signaling.