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Jump to Key Points Oct 23 (Reuters) - Bristol Myers Squibb on Friday disclosed a patient death in an early-stage trial studying its experimental CAR-T cell therapy in patients with relapsing or progressive forms of multiple sclerosis.
The death, which the company said occurred after the study was paused, was disclosed as part of a readout at a conference.
The patient, who was participating in the trial of the company's experimental cell therapy zolacabtagene autoleucel, or zola-cel, died of septic pneumonia a day after receiving high-dose chemotherapy, and 44 days after the CAR-T infusion.
The company said the patient with highly active relapsing MS had developed delayed motor symptoms that did not respond to treatment.
- Early-stage zola-cel trial in relapsing/progressive MS enrolled 66 patients.
- One death: septic pneumonia 1 day post-high-dose chemotherapy; 44 days post-CAR-T.
- Patient had delayed motor symptoms; no response to treatment before death.
- Company cites confounders: heavy pretreatment, late toxicity; root cause unclear.
- Zola-cel studies paused for safety review; FDA restart sought, enrollment target early 2027.
"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 death was unrelated to a recent voluntary pause on other studies on zola-cel, the spokesperson said.
In September, Bristol said it implemented a voluntary pause on studies for zola-cel to review safety data, after Novartis halted eight clinical trials of its experimental cell therapy.
Bristol is working with the FDA to restart all studies and aims to resume enrollment in early 2027, the spokesperson said.
Shares of the drugmaker were trading more than 2% lower on Friday.
Zola-cel targets CD19, a protein found on certain cells that are believed to play a role in autoimmune diseases.
The early-stage trial enrolled 66 patients with relapsing or progressive forms of MS.
The company said the majority of the side effects were brief and reversible, generally consistent with the previously reported zola-cel data, and that the findings support the therapy's potential to reset the immune system in people with autoimmune diseases.
"We remain confident in the safety and efficacy profile we have observed in Phase 1, which has demonstrated preliminary transformational treatment-free responses across multiple autoimmune settings and manageable safety," the spokesperson said.
No additional severe side effects have been reported across all zola-cel programs in autoimmune diseases, which include 190 patients treated in early studies, the company said.
(Reporting by Sriparna Roy and Kamal Choudhury in Bengaluru; Editing by Shinjini Ganguli)
