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Bristol Myers Squibb Presents Results from Phase 1 Breakfree-2 Study of Zolacabtagene Autoleucel (BMS-986353) in Patients with Highly Active Relapsing and Progressive Forms of Multiple Sclerosis at MSToronto 2026

Bristol-Myers Squibb

Data reinforce the potential for immune reset with zolacabtagene autoleucel to address an underlying cause of multiple sclerosis

PRINCETON, N.J., October 23, 2026--Bristol Myers Squibb (NYSE: BMY) today announced disclosure of interim safety and efficacy results from the multiple sclerosis (MS) cohorts of the Phase 1, single-arm, dose-escalation Breakfree-2 study evaluating zolacabtagene autoleucel (zola-cel; BMS-986353), an investigational, autologous CD19-directed CAR T cell therapy, in patients with highly active relapsing MS (haRMS) and progressive forms of MS (PMS). The data are being presented today in an oral presentation (Abstract #1615) at MSToronto 2026, the 10th Joint ACTRIMS-ECTRIMS Meeting taking place in Toronto, Canada.

The study included 66 patients (30 patients with haRMS and 36 patients with PMS) with ongoing disease activity or worsening disability despite treatment. Patients had a median of two prior disease-modifying therapies (DMTs) (range: 1-8 haRMS; 1-6 PMS). The primary endpoint of the study was safety, with efficacy as the secondary endpoint. The data presented show a safety profile consistent with previously reported zola-cel Phase 1 clinical trial data and early, promising efficacy across both haRMS and PMS with all patients treated at dose level 2 (DL2) (60/60) remaining off DMTs.

In the Breakfree-2 study, the majority of adverse events were brief and reversible, generally consistent with previously reported zola-cel Phase 1 clinical trial data.

  • Overall, 42.4% of patients (28/66) had cytokine release syndrome (CRS) events. Majority were Grade 1 (36.4%), with some Grade 2 (6.1%) and all resolved in a median of two days.

  • 7.6% of patients (5/66) had immune effector cell-associated neurotoxicity syndrome (ICANS), most of which were Grade 1/2, which resolved in a median of two days.

  • One Grade 4 ICANS event occurred in a patient with PMS and was managed with corticosteroids and anakinra and resolved within four days.

After the data cutoff, one patient with haRMS experienced a fatal event of septic pneumonia. Following zola-cel infusion, the patient experienced late onset, non-ICANS motor symptoms that were not resolved by treatment with intermittent corticosteroids and intravenous immunoglobulin (IVIG). Although the patient's CAR T cell expansion was consistent with that observed across the study, high-dose cyclophosphamide was administered and the patient developed septic pneumonia and died the following day, 44 days after infusion. No additional Grade 5 events have been reported across all zola-cel programs in autoimmune diseases, which include 190 patients treated in Phase 1 studies.

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