A Phase 1 Multicenter Open-Label Study Of CC-97540 (BMS-986353) CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells in Participants with Severe Refractory Systemic Lupus Erythematosus (SLE)

Brief description of study

This study will enroll participants with SLE who have a severe, life-threatening disease course and have been refractory to currently available therapies. Because of the recognized pathogenic role of autoreactive B cells and plasmablasts in patients with SLE, the current study will explore the potential utility of depletion of CD19+ B cells and plasmablasts with CD19-specific CAR T cells in this dose-ranging study to achieve deep and sustained elimination of autoreactive B cells and plasmablasts, inducing disease remission and potentially restoring humoral immune tolerance.
The present study aims to establish the tolerability and preliminary efficacy of the leukapheresis, lymphodepletion and infusion of the study intervention, CC-97540, as well as the pharmacokinetics of CC-97540, and depth and duration of B cell depletion.

Clinical Study Identifier: s23-00222
Principal Investigator: Amit Saxena.

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