Bristol Myers Squibb said a patient in its Phase 1 trial of zolacabtagene autoleucel, a CD19-targeting CAR-T therapy, developed delayed motor symptoms that did not respond to corticosteroids or intravenous immunoglobulin, then received high-dose chemotherapy, developed septic pneumonia and died the next day, 44 days after the infusion. The trial enrolled 66 patients, 30 of them with highly active relapsing multiple sclerosis; 42.4 percent had cytokine release syndrome events, and five cases of immune effector cell-associated neurotoxicity syndrome resolved in about two days. Bristol Myers had voluntarily paused its zola-cel studies in September while it reviewed safety data, after Novartis paused its own autoimmune CAR-T trials, and its shares were trading about 2 percent lower after Friday’s disclosure, Reuters reported.
Patient dies in Bristol Myers autoimmune CAR-T trial
Bristol Myers Squibb disclosed on Friday that a patient with highly active relapsing multiple sclerosis died of septic pneumonia 44 days after receiving its experimental CD19 CAR-T therapy, zolacabtagene autoleucel, in a Phase 1 trial.
Why it matters: The death lands while autoimmune CAR-T programs at Bristol Myers and Novartis are already paused or under safety review, and it tests whether cell therapy can move into autoimmune disease with an acceptable risk profile.
Data as of Bristol Myers Squibb disclosure of October 23, 2026, as reported the same day by STAT, whose article was read in full, and by Reuters. Developing item.
Sources
- Patient dies in Bristol Myers Squibb autoimmune CAR-T trial - STAT - 2026-10-23
- Bristol Myers discloses patient death in early-stage cell therapy study - Reuters - 2026-10-23