eligibility_summary
Include: 18–60, SLE with refractory disease: persistent activity on antimalarial + MMF ≥1500 mg/d or AZA ≥1.5 mg/kg/d and need ≥7.5 mg pred or SLEDAI ≥8, or biopsy‑proven proliferative LN refractory to IV CYC ≥1.5 g + MMF ≥3 mo, or worsening despite high‑dose steroids + MMF/CYC. Contraception to 4 mo post CAR‑T. Exclude: pregnant/breastfeeding, cancer, prior transplant, unstable illness, HIV/HBV/HCV, severe CYC/FLU ADR, live vaccine <30 d, eGFR <30, other trials, prior CAR‑T.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 single-arm trial of autologous piggyBac transposon–engineered CD19 CAR T cells (1x10^6 cells/kg) for refractory SLE. Type: adoptive cellular gene therapy. Mechanism: patient T cells are gene-modified with a nonviral piggyBac transposon to express an anti-CD19 chimeric receptor, after infusion they recognize CD19, activate cytotoxicity, and deplete CD19+ B-lineage cells to eliminate autoreactive clones and reduce autoantibodies. Preconditioning lymphodepletion uses fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) to enhance CAR T expansion. Targets/pathways: CD19+ B cells (naive, memory, plasmablasts), humoral autoimmunity, antigen presentation/cytokine outputs driving SLE.