Nex-T TMCluster of Differentiation 19 (CD19) Chimeric Antigen Receptor (CAR) T-Cell Therapy BMS-986353 (CC-97540): Comparative Analysis of Baseline Patient Data from Trials in Systemic Lupus Erythematosus (SLE) and Relapsed/Refractory Large B-Cell Lymphoma (R/R LBCL) Related to Manufacturability and Potential Safety

Introduction: CAR T-cell therapy is currently being evaluated in non-oncologic autoimmune diseases (Mougiakakos D et al. N Engl J Med2021; Müller F et al. Lancet2023). In a cohort of patients (pts) with SLE, CD19 CAR T-cell therapy resulted in B-cell depletion and treatment-free, durable remission per Definitions of Remission In SLE (DORIS), suggesting that CD19 CAR T therapy may be feasible, well-tolerated, and effective for patients with SLE (Mackensen A et al. Nat Med2022). Baseline traits associated with greater manufacturing success and lower toxicity profiles for CAR T have been identified in hematologic oncology (Mashadi-Hossein A et al. J Clin Oncol2023; Rytlewski J et al. J Clin Oncol2022) including age, bone marrow function, inflammatory state, and tumor burden. Here, we compared baseline traits in pts with active SLE versus R/R LBCL to predict the potential manufacturing success and toxicity profile for the ongoing phase 1 study to evaluate the investigational NEX-T TMCAR T-cell product BMS-986353 (CC-97540) in pts with severe, refractory SLE (NCT05869955).