eligibility_summary
Eligibility: Adults 18–65 with SLE per 2019 EULAR/ACR and positive ANA or anti-dsDNA. LN cohort: active, biopsy-proven class III/IV ± V (2018 ISN/RPS). Non-renal cohort: active moderate–severe SLE. Exclude: leukapheresis contraindication, severe reaction to fludarabine/cyclophosphamide, active infection, severe/uncontrolled organ disease, investigator risk, non-lupus kidney disease (LN only), prior CAR-T, prior solid-organ or HCT transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06121297 (RESET-SLE) is a Phase 1/2, open-label, single-arm study in adults with active SLE (with or without lupus nephritis) testing CABA-201, an autologous CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy. Participants receive lymphodepleting preconditioning with cyclophosphamide (alkylating DNA crosslinker) and fludarabine (purine analog) followed by a single IV infusion of CABA-201. Mechanism: engineered T cells recognize CD19 to selectively eliminate CD19+ B-lineage cells (naive/memory B cells and plasmablasts), aiming to ablate autoreactive B cells, reduce autoantibody production, and reset immune tolerance. Targeted cells/pathways: CD19+ B cells, B-cell receptor/autoantibody and germinal center pathways central to SLE.