Bristol Myers Reports Death in CAR-T Trial

Bristol Myers Squibb reported that a patient with highly active relapsing multiple sclerosis died of septic pneumonia during an early-stage trial of its experimental CAR-T therapy, zolacabtagene autoleucel, or zola-cel. The patient developed the infection after high-dose chemotherapy and died 44 days after the CAR-T infusion; the company had paused zola-cel studies in September while reviewing safety data. Interim Phase 1 results covering 66 patients showed early efficacy signals and that most reported side effects were brief and reversible, though the study also recorded a severe neurotoxicity event and the fatal case. Separately, the company said it had identified the cause of the safety concern and intends to resume suspended CAR-T trials by 2027. The death adds to scrutiny of CAR-T treatments for autoimmune diseases after three deaths in a separate Novartis program.