Biologics

Patient Dies Following BMS Cell Therapy in Multiple Sclerosis Trial

Bristol Myers Squibb reported preliminary safety and efficacy data from a Phase 1 study of its investigational CAR T-cell therapy zolacabtagene autoleucel (zola-cel; BMS-986353) in patients with multiple sclerosis, but disclosed that one trial participant died of septic pneumonia 44 days after receiving treatment.

The death reportedly occurred in a patient with highly active relapsing multiple sclerosis (haRMS) after the data cutoff for the Phase 1 Breakfree-2 study. According to BMS, the patient developed delayed motor symptoms unrelated to immune effector cell-associated neurotoxicity syndrome (ICANS) that did not resolve with intermittent corticosteroids and intravenous immunoglobulin.

The patient subsequently received high-dose cyclophosphamide and developed septic pneumonia, dying the following day. BMS did not specify whether investigators considered the death directly related to zola-cel. The company said no other Grade 5 events have been reported among 190 patients treated across its Phase 1 zola-cel autoimmune disease programs.

The interim findings, presented at the MSToronto 2026 meeting, involved 66 patients with highly active relapsing MS (30 patients) or progressive MS (36 patients) whose disease remained active or disability worsened despite previous treatment.

Among the 66 patients, cytokine release syndrome occurred in 42.4%, predominantly Grade 1, while ICANS occurred in 7.6%, according to BMS. One patient with progressive MS experienced Grade 4 ICANS that resolved within four days following treatment with corticosteroids and anakinra.

BMS reported that all 60 patients treated at dose level 2 remained off disease-modifying therapies at their latest follow-up, including nine patients followed for more than 12 months.

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Petition Seeks Immune Monitoring Requirements for Vertex's Povetacicept

Most Digital Health Submissions Involve Patient-Reported Data, Not Sensors: FDA

Texas Wins $45 Million Gilead Settlement Over ‘Kickback Scheme’

Merck, Moderna Report Positive Data for Cancer Vaccine