Bristol Myers Squibb reports interim Phase 1 CAR T data in multiple sclerosis
+3 new sources since this summary was written
Bristol Myers Squibb presented interim results from the Phase 1 Breakfree-2 study of investigational zolacabtagene autoleucel, or zola-cel, in highly active relapsing and progressive multiple sclerosis at MSToronto 2026 on October 23, 2026. The study enrolled 66 patients and found cytokine release syndrome in 42.4% and immune effector cell-associated neurotoxicity syndrome in 7.6%, while one patient later died from septic pneumonia 44 days after treatment. All 60 patients treated at dose level 2 remained off disease-modifying therapies, with efficacy signals reported across both patient groups.
Why it matters
The results add clinical data to Bristol Myers Squibb's investigational CAR T program in multiple sclerosis, but the reported fatal infection remains a material safety consideration. Because Breakfree-2 is a Phase 1 study with safety as its primary endpoint, the findings do not establish regulatory approval or commercial availability.
Key facts
- 1Breakfree-2 included 66 patients, comprising 30 with highly active relapsing multiple sclerosis and 36 with progressive forms of the disease. finance.yahoo.com
- 2Cytokine release syndrome occurred in 42.4% of patients, while immune effector cell-associated neurotoxicity syndrome occurred in 7.6%. finance.yahoo.com
- 3One patient with highly active relapsing multiple sclerosis died of septic pneumonia 44 days after receiving zola-cel. finance.yahoo.com
- 4All 60 patients treated at dose level 2 were still off disease-modifying therapies at the latest follow-up. finance.yahoo.com
- 5Among evaluable patients, six of seven with highly active relapsing multiple sclerosis met no-evidence-of-disease-activity criteria at or beyond Week 26. finance.yahoo.com
- 6Among evaluable progressive multiple sclerosis patients, 22 of 24 showed stable or improved disability progression, and all 24 had no new MRI activity. finance.yahoo.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.