eligibility_summary
Inclusion: adults 18–70 with active SLE (EULAR/ACR ≥10, SELENA-SLEDAI ≥8), CD19+ B cells, adequate counts/organ function (CrCl ≥30, LVEF ≥50%), venous access, neg pregnancy test/contraception, consent/follow-up. Exclusion: severe renal (incl. dialysis) or CNS disease, immunodeficiency or active infection (HIV, HBV/HCV, syphilis), recent IS meds/live vaccine/surgery, Cy/Flu CI, pregnant/lactating, prior CD19/BCMA tx, recent trial, active malignancy (exceptions), PI judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05858684 tests GC012F, an autologous, dual‑target CD19/BCMA chimeric antigen receptor T‑cell (CAR‑T) therapy in refractory SLE (early phase, single-arm, dose escalation). Mechanism: patient T cells are engineered to express CARs recognizing CD19 and BCMA, enabling targeted cytolytic depletion of CD19+ B cells (naive/memory) and BCMA+ plasmablasts/plasma cells. Intended effect: ablate autoreactive B‑cell compartments, stop autoantibody production and immune complex formation, diminish B‑cell antigen presentation to T cells, reduce inflammatory cytokine signaling, and allow immune reconstitution. Primary targets: CD19 on B cells and BCMA on antibody‑secreting cells, key pathways impacted: autoantibody/immune complex–driven inflammation and B–T cell activation.