Bristol Myers Squibb said Oct. 23 a study participant died from septic pneumonia about six weeks after receiving a dose of a CAR-T cell therapy being tested for multiple sclerosis.
The phase 1 trial included 66 patients with highly active relapsing multiple sclerosis or progressive forms of multiple sclerosis. In the study, most adverse events were “brief and reversible,” according to BMS.
After receiving the CAR-T therapy, zolacabtagene autoleucel, 28 of the 66 participants experienced cytokine release syndrome events, or hyperinflammation. Six patients had immune effector cell-associated neurotoxicity syndrome, including one life-threatening case, which resolved within two to four days.
One patient with highly active relapsing multiple sclerosis developed septic pneumonia and died the next day, 44 days after zola-cel infusion, BMS said. The patient received intermittent corticosteroids and intravenous immunoglobulin.
“No additional Grade 5 [fatal] events have been reported across all zola-cel programs in autoimmune diseases, which include 190 patients treated in Phase 1 studies,” BMS said.
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