S15:01 Safety and efficacy of CD19 NEX-T® (BMS-986353)—a CD19-directed chimeric antigen receptor (CAR) T cell therapy—for severe refractory systemic lupus erythematosus (SLE): breakfree-1 trial update

Objectives In Breakfree-1 (NCT05869955), BMS-986353 (CD19 NEX-T), a CD19-directed CAR T cell therapy, showed promising early safety and efficacy in severe, refractory SLE.We report updated data for SLE cohort.Methods Breakfree-1 enrolled patients with active, severe (recent BILAG A score) SLE, with inadequate response to at least 2 immunosuppressants and steroids.Following lymphodepletion, a single BMS-986353 infusion was administered at 1010^6 (dose level [DL] 1) or 2510^6 CAR+ T cells (DL2).SLE-directed therapies were discontinued before lymphodepletion.Primary endpoint: safety.