Bristol Myers Squibb Discloses Patient Death in Early-Stage Cell Therapy Trial: Septic Pneumonia 44 Days After Infusion
Bristol Myers Squibb disclosed on October 23, in a trial data readout at a conference, that a patient had died in an early-stage trial of its experimental CAR-T cell therapy. According to Reuters, the patient, who had highly active relapsing multiple sclerosis, died of septic pneumonia one day after receiving high-dose chemotherapy and 44 days after infusion of the therapy, zolacabtagene autoleucel, or zola-cel.
The early-stage trial enrolled 66 patients with relapsing or progressive forms of multiple sclerosis. The company said the patient who died had been heavily pretreated before receiving CAR-T, developed delayed motor symptoms that did not respond to treatment, and suffered a series of other complications. "The patient had a late onset side effect, a series of other complications and was heavily pretreated prior to CAR T, confounding our ability to determine the root cause of the issue," a company spokesperson said. The spokesperson said the death was unrelated to the company's recent voluntary pause on other zola-cel studies. Bristol Myers Squibb paused zola-cel studies in September to review safety data, after Novartis halted eight clinical trials of its own experimental cell therapy.
Zola-cel targets CD19, a protein found on certain cells believed to play a role in autoimmune diseases. The company said most side effects in the trial were brief and reversible, generally consistent with previously reported zola-cel data, and that the findings support the therapy's potential to reset the immune system in people with autoimmune diseases. Bristol Myers Squibb is working with the U.S. Food and Drug Administration (FDA) to restart all of the studies and aims to resume enrollment in early 2027. The drugmaker's shares were trading more than 2% lower on Friday.
Source: GSM · USA (original Chinese edition)
Photo: 百时美施贵宝位于 New Jersey 州 Lawrenceville 的研发园区（资料图）。照片：Coolcaesar，CC BY-SA 3.0，经 Wikimedia Commons。 / Bristol Myers Squibb research campus in Lawrenceville, New Jersey (file photo). Photo: Coolcaesar, CC BY-SA 3.0, via Wikimedia Commons.
