Bristol Myers Squibb disclosed a death in a Phase 1 multiple-sclerosis trial of its experimental CAR-T therapy, zolacabtagene autoleucel (zola-cel). The patient died of septic pneumonia 44 days after infusion, after developing delayed motor symptoms and receiving high-dose cyclophosphamide.
The company said it could not determine the root cause with certainty, noting the patient had other complications and had received extensive prior treatment. The death was reported after the study’s data cutoff.
In the 66-person study, cytokine release syndrome was reported in 42.4% of participants, mostly mild; neurotoxicity was reported in 7.6%. Most reported events resolved, though one serious neurotoxicity event required treatment.
The disclosure lands amid wider scrutiny of CAR-T for autoimmune diseases after fatal events in a separate Novartis program. BMS had already voluntarily paused zola-cel study enrollment while reviewing safety data; the company said it was working with the FDA and hoped to resume enrollment in early 2027.
BMS said this was the only reported death among 190 patients treated across its Phase 1 autoimmune-disease zola-cel programs. The findings are preliminary, and the reported case does not by itself establish that the therapy caused the death.
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