On 23 October, US-based Bristol Myers Squibb Co disclosed that a patient with highly active relapsing multiple sclerosis died of septic pneumonia following the data cutoff in a Phase 1 trial. The study involved the treatment of patients with autoimmune neurological diseases with a chimeric antigen receptor (CAR) T cell therapy targeting CD19 on B cells.
The therapy, zolacabtagene autoleucel (zola cel), was being tested in 66 patients of whom 30 had highly active relapsing multiple sclerosis and 36 had progressive forms of multiple sclerosis. Prior to the study, the patients had received a median of two therapies. According to the company, the majority of adverse events in the study were brief and reversible. The fatality occurred after the data cutoff and involved an individual with highly active relapsing multiple sclerosis. Death was due to septic pneumonia.
In a statement, BMS said that following infusion, the patient experienced late onset, non-immune effector cell-associated neurotoxicity syndrome (ICANS) motor symptoms that were not resolved by treatment with intermittent corticosteroids and intravenous immunoglobulin.
The company said the cells had been manufactured using a five-day process to enable them to reach a stable vector integration.
Separately, BMS told the STAT newsletter that the inflammatory complications it observed were not related to the duration of the manufacturing process. The incident follows the deaths of three patients in a clinical-stage CAR T autoimmune programme being run by Novartis earlier in the year.
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