eligibility_summary
Adults 18–65 with SLE (2019 EULAR/ACR) and ANA≥1:80 or anti‑dsDNA/anti‑Sm, active disease (BILAG A/≥2 B, SELENA‑SLEDAI≥8), CD19+ B cells, refractory after ≥2 therapies. Require adequate marrow, liver, renal (CrCl≥60), coag, and cardiac function (LVEF≥55%). Exclude serious allergy/infection/CNS/heart disease, other malignancy, ESRD, recent high‑dose steroids, investigational drugs, anti‑CD20, or prior CAR‑T, HBV/HCV/HIV/syphilis+, psychiatric illness, recent trial, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: BRL-301, a single-dose allogeneic anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy. Mechanism: donor-derived T cells are engineered to express a CAR targeting CD19, enabling selective cytotoxicity against CD19+ B cells, leading to profound B-cell depletion to ablate autoreactive pools and reset humoral immunity in refractory SLE, administered after lymphodepleting chemotherapy. Targets: CD19 on B cells/plasmablasts, consequent suppression of autoantibody production and B cell–driven immune activation.