Early Promise and Hypothesis Behind CAR T-Cell Therapy BMS-986353 in Multiple Sclerosis: Rosanna Ricafort, MD

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"We see robust CD 19, next T cell expansion in an evaluable patient thus far, and that's consistent with what we've achieved with the approved dose of liso-cel."

Chimeric antigen receptor (CAR) T-cell therapy represents a promising new frontier in the treatment of various diseases, including autoimmune disorders like multiple sclerosis (MS), particularly progressive forms of MS. The idea behind targeting and eliminating the autoreactive B cells that contribute to the immune system’s attack on the central nervous system has been based on the success of previous CAR T-cell therapies in treating B cell malignancies, such as lymphoma and leukemia, where engineered T cells have been able to selectively target and destroy cancerous B cells.

An emerging investigational CAR T-cell treatment, BMS-986354 (BMS), is currently being tested in a phase 1, open-label study (NCT06220201) of patients with progressive or relapsing MS. Two to 9 days after lymphodepletion, patients received a single infusion of the agent at a dose of 5 x 10⁶ CAR+ T-cells. New data from the study presented at the 2025 Americas Committee for Treatment & Research in Multiple Sclerosis (ACTRIMS) Forum, held February 27-March 1 in West Palm Beach, Florida, demonstrated promising initial safety data with BMS-986354, as there were no reports of immune effector cell-associated neurotoxicity syndrome (ICANS).

Prior to the meeting, NeurologyLive^® sat down with Rosanna Ricafort, MD, vice president and senior global program lead for Hematology and Cell Therapy at BMS, to discuss the mechanism behind BMS-986354 and the promising initial findings from the study. In the discussion, Ricafort outlined some of the preliminary safety and efficacy findings, such as the lack of dose-limiting adverse events and deep B cell depletion within 8 days of treatment. Overall, she noted that while these data are early, they represent a promising step for the potential of this therapy.

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REFERENCE
1. Repovic P, Pul R, von Treschkow B, et al. P103. A Phase 1, Multicenter, Single-Arm, Dose-Escalation Study of BMS-986353 (CC-97540), a CD19-Directed Chimeric Antigen Receptor T Cell Therapy Manufactured Using a Next-Generation Process, Evaluating Safety and Tolerability in Patients With Relapsing or Progressive Forms of Multiple Sclerosis (Breakfree-2). Presented at: 2025 ACTRIMS Forum; February 27-March 1; West Palm Beach, FL. ABSTRACT P103.