Talk Bio

Bristol Myers Squibb (BMS) disclosed that a participant in a Phase 1 trial of its experimental CAR-T therapy, zolacabtagene autoleucel (zola-cel), for multiple sclerosis died of septic pneumonia. The patient died 44 days after infusion and the day after receiving high-dose cyclophosphamide. BMS said the patient had developed late-onset motor symptoms that did not resolve with corticosteroids and intravenous immunoglobulin. The company noted that the patient had other complications and had been heavily pretreated, making the cause difficult to determine. BMS says the death was not connected to its earlier pause in zola-cel enrollment, which was prompted by a separate pattern of transient, reversible inflammatory events. The company reported no other fatal events among 190 people treated in its autoimmune-disease studies. BMS says it has identified the cause of the earlier safety trend and is working with health authorities, including the FDA, to restart studies. It is targeting a ...