eligibility_summary
Adults/children ≥5 with SLE (2019 EULAR/ACR), active disease (SLEDAI≥8) refractory to ≥3 mo high‑dose steroids + HCQ + ≥2 immunosuppressants (or intolerant), with adequate organ function (LVEF≥55%, eGFR≥30, AST/ALT≤3×ULN, TBIL≤2×ULN, SpO2≥92%), eligible for leukapheresis, negative pregnancy test/contraception, consent. Exclude: prior CAR‑T, neuro‑SLE needing recent treatment, severe nephritis, significant cardiac disease, other major immunosuppression needs, infections, transplant/GVHD, HBV/HCV viremia, HIV, syphilis, CMV, live vaccine <4 wks, pregnancy, malignancy, recent trial, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: anti-CD19 CAR-T cells—autologous, genetically engineered T cells (cellular gene therapy). Mechanism of action: CAR-T cells recognize CD19 on B-lineage cells and kill them via T-cell cytotoxicity, inducing deep, sustained depletion of CD19+ naive and memory B cells and plasmablasts. This reduces pathogenic autoantibody production and may reset B-cell immunity, enabling disease control without chronic immunosuppression. Design: open-label, single-arm, dose-escalation (0.3×10^5, 1×10^5, 3×10^5 cells/kg) in refractory SLE to assess safety and efficacy. Target cells/pathways: CD19+ B cells, B-cell receptor–driven autoimmunity, germinal center activity, autoantibody and immune complex formation that drive SLE inflammation (including nephritis).