Bristol Myers Reports Death in CAR-T Trial

A patient with highly active relapsing multiple sclerosis died of septic pneumonia 44 days after receiving Bristol Myers Squibb's experimental CAR-T therapy zolacabtagene autoleucel (zola-cel, BMS-986353) in the Phase 1 Breakfree-2 trial. The patient developed the infection after high-dose chemotherapy and had delayed motor symptoms unresponsive to corticosteroids or intravenous immunoglobulin. BMS had paused the zola-cel studies in September out of an abundance of caution. No contested claims found in the record. On Oct. 23, 2026 BMS presented interim data at MSToronto 2026 covering 66 patients (30 highly active relapsing MS, 36 progressive MS) with a median of two prior disease-modifying therapies. Most adverse events were brief and reversible; a Grade 4 ICANS event resolved within four days after corticosteroids and anakinra. BMS reported no additional Grade 5 events across 190 patients in its zola-cel autoimmune programs. The company said it has identified the cause of the safety issue and intends to resume the trials by 2027. Shares fell 2.5% that Friday. Novartis had separately paused eight rap-cel trials. Dr. Jeffrey A. Cohen of Cleveland Clinic said people living with relapsing and progressive forms of multiple sclerosis need treatment options that address the underlying disease while helping control relapses and preserve function, and that the data suggest CD19-directed CAR T cell therapy may offer a new approach.