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Emerging treatmentsPhase 1 study evidenceCurrent status unknown

Zola-cel: CAR T cells made from a person's own cells, in relapsing and progressive MS

Published by MyelinWatch:

Organisation
Bristol Myers Squibb · United States
Study sponsor
Juno Therapeutics, a Bristol Myers Squibb company
Researcher
Jeffrey A. Cohen and colleagues

Zola-cel (BMS-986353) / Breakfree-2 · Breakfree-2 studies zola-cel (BMS-986353), CAR T cells made from each person's own T cells and designed to target CD19-positive B cells. Participants receive chemotherapy to lower their immune cells first, then a single infusion. This Phase 1 study has one treatment group, no comparison group, and safety as its main measure.

What is being studied

Breakfree-2 studies zola-cel (BMS-986353), CAR T cells made from each person's own T cells and designed to target CD19-positive B cells. Participants receive chemotherapy to lower their immune cells first, then a single infusion. This Phase 1 study has one treatment group, no comparison group, and safety as its main measure.

Research stage

Phase 1 study evidence; current programme status is unknown

Current programme and human-study status are unknown.

What we know so far

Interim conference data cover 66 people. One person with highly active relapsing MS died of septic pneumonia 44 days after infusion, after the data cutoff. Cytokine release syndrome occurred in 28/66 and the neurotoxicity syndrome ICANS in 5/66, including one Grade 4 event that resolved. Among people on the main dose with at least 26 weeks of follow-up, 22 of 24 with progressive MS were reported as stable or improved on disability and 24 of 24 had no new MRI activity. These results come from the company and have no comparison group.

What this means for patients today

Zola-cel remains experimental and is not an available MS treatment. Its safety is not established, how it contributed to the death remains unresolved, and these observations cannot show that it slows disability. On 3 August 2026 the official record listed the study as not accepting new participants; a later report says the company paused its zola-cel studies.

Treatment or approach
Autologous CD19-directed CAR T cells for relapsing and progressive MS
How it is intended to work
Autologous anti-CD19 CAR T-cell therapy
Where the study is running
Registry sites in the United States, Belgium, France, Germany, Spain and the United Kingdom
Source: Bristol Myers Squibb — official company announcement ↗Source: ClinicalTrials.gov — Breakfree-2, NCT06220201 ↗ Source: Healio — report of the presentation, 2 November 2026 ↗ Source: Pharmaceutical Executive — report on the death and the study pause, 26 October 2026 ↗
Published by MyelinWatch
Last substantive MyelinWatch update

Programme updates — newest research developments first

  1. Interim human results from a Phase 1 study with one treatment group and no comparison groupResearch event/source date:

    Zola-cel: one death and early observations in a Phase 1 CAR-T study in 66 people with MS

    On 23 October 2026, Bristol Myers Squibb reported interim results from the Phase 1 Breakfree-2 study of zola-cel, an experimental CD19-directed CAR T-cell therapy made from a person's own cells and given as a single infusion. One person with highly active relapsing multiple sclerosis (MS) died of septic pneumonia 44 days after the infusion. The death happened after the data cutoff. This person had late-onset motor symptoms, described as non-ICANS, that did not resolve with corticosteroids and intravenous immunoglobulin, received high-dose cyclophosphamide, developed septic pneumonia and died the following day. The study has no comparison group. It included 66 people: 30 with highly active relapsing MS and 36 with progressive MS. Cytokine release syndrome occurred in 28/66 and the neurotoxicity syndrome ICANS in 5/66, including one Grade 4 event that resolved within four days. Among people who received the main dose and had at least 26 weeks of follow-up, 22 of 24 with progressive MS were reported as stable or improved on disability and all 24 had no new MRI activity. In highly active relapsing MS, 6 of 7 evaluable people had no evidence of disease activity.

    Source: Bristol Myers Squibb — official company announcement ↗Source: ClinicalTrials.gov — Breakfree-2, NCT06220201 ↗ Source: Healio — report of the presentation, 2 November 2026 ↗ Source: Pharmaceutical Executive — report on the death and the study pause, 26 October 2026 ↗