BMS reports patient death in MS CAR-T trial, cites septic pneumonia and pauses enrollment

BMS disclosed details about a patient death that occurred in its investigational CAR-T therapy for multiple sclerosis.

The autologous CD19-directed CAR-T, zolacabtagene autoleucel (zola-cel), had enrollment paused in August after transient inflammatory events. The patient died 44 days after infusion, a day after receiving high-dose cyclophosphamide, from septic pneumonia and late-onset motor symptoms that did not improve with steroids or IVIG.

BMS said no other deaths have been reported among the 190 patients treated in autoimmune trials and stressed the fatal case happened after the enrollment pause, indicating it was unrelated to the pause decision.

The company said it will continue to evaluate safety data and work to bring the program back on track.