BMS reports fatal septic pneumonia in MS patient during CAR T trial of zolacabtagene autoleucel

BMS disclosed that a participant in its Phase 1 Breakfree-2 study of the CAR T cell therapy zolacabtagene autoleucel died from septic pneumonia.

The patient, who had highly active relapsing multiple sclerosis, developed late-onset neurotoxicity symptoms after infusion that were not resolved by corticosteroids and IVIG, and succumbed the day after pneumonia onset, 44 days post-infusion.

The death follows BMS's earlier decision in late August to pause several autoimmune trials of the same therapy after safety signals emerged, though the company said no other deaths have been reported among the roughly 190 autoimmune patients treated in Phase 1 studies.

The findings were disclosed ahead of a data presentation at the ACTRIMS-ECTRIMS meeting, highlighting ongoing safety concerns for CAR T approaches in autoimmune diseases.