eligibility_summary
Include: ≥5 yrs, SLE (2019 EULAR/ACR), SLEDAI-2K ≥8, refractory to ≥3 mo high-dose steroids + HCQ + ≥2 IS drugs or intolerant, adequate organ function (LVEF ≥55%, eGFR ≥30, AST/ALT ≤3×ULN, TBIL ≤2×ULN, SpO2 ≥92%), eligible for leukapheresis, negative pregnancy/contraception, consent. Exclude: prior CAR-T, CNS lupus ≤60 d, active TB/infection, major heart disease, steroid-dependent comorbidities, transplant/GVHD, HBV/HCV/HIV/syphilis/CMV, live vaccine <4 wks, pregnancy, malignancy, other trial <3 mo, unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06691152 (Phase 1, open-label, single-arm, dose-escalation, China, recruiting). Intervention/type: CD19 Universal CAR-T cells—an allogeneic, off-the-shelf cellular immunotherapy (biologic). Mechanism of action: Donor-derived T cells are engineered with an anti-CD19 chimeric antigen receptor to recognize and kill CD19+ B-lineage cells. This induces deep, temporary B-cell aplasia, depletes autoreactive B cells/plasmablasts, reduces autoantibody production, and aims to “reset” humoral immunity in refractory SLE. Target cells/pathways: CD19-expressing B cells (naïve and memory B cells, plasmablasts), downstream impact on B-cell receptor signaling, germinal center responses, autoantibody generation, and complement/immune complex–mediated inflammation. Dosing: 1×10^7, 3×10^7, or 6×10^7 cells/kg.