Bristol Myers Squibb disclosed Friday that a patient died during a Phase 1 study of its experimental CAR-T cell therapy, zolacabtagene autoleucel (zola-cel), for multiple sclerosis. The company’s shares fell 2.5% in early trading after the news.
The patient developed motor symptoms, which were treated with other medications, and died of septic pneumonia 44 days after receiving the therapy infusion. The trial is part of Bristol Myers’ broader effort to use cell therapies—typically used to treat cancer—for autoimmune diseases.
The company said this was the only fatal event reported across its zola-cel autoimmune programs, which have treated 190 patients in Phase 1 studies. Bristol Myers paused enrollment in its autoimmune CAR-T trials in June as a precaution while it reviewed safety data.