Tests a CAR T cell therapy against standard care in systemic sclerosis
Compares a CAR T cell treatment with standard care in people with active systemic sclerosis.
Plain-language title generated from the registry record
Registry title: A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis
Key facts
- Where
- Bordeaux, Bron, Paris, Rennes, Strasbourg Cedex 2, and Toulouse Cedex 9, FranceSee the 6 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with active systemic sclerosis who also have interstitial lung disease and have not responded to, or could not tolerate, earlier medicine for their condition.
- Age
- 16 years or older.
- Sex
- All sexes can join.
- Disease stage
- Active systemic sclerosis (meets the 2013 ACR/EULAR criteria) with interstitial lung disease on a lung CT scan covering at least 10% of the lungs. Active disease means at least one of: arthritis, myositis, carditis, progressive skin disease, or high inflammation markers.
- Earlier treatment
- Must have had no response to, or not tolerated, at least 6 months of treatment with at least one immunomodulatory drug.
- Biomarker or test result
- Positive antinuclear antibodies (ANA) with a nucleolar pattern and/or anti-Topoisomerase I (anti-Scl-70) antibodies.
Main reasons for not taking part
- Needs extra oxygen, or lung diffusing capacity (DLCO) of 40% or lower
- Moderate to severe pulmonary arterial hypertension needing combination treatment
- Smoked cigarettes or e-cigarettes in the last 3 months, or unwilling to avoid smoking during the study
- Gut problems needing total parenteral nutrition (TPN)
- Current gangrene of a finger or toe
Read by machine on 12 November 2026.
Where in France
- Pellegrin HospitalBordeaux, FranceNot yet recruiting
- Hospices Civils de LyonBron, FranceNot yet recruiting
- Assistance Publique Hopitaux de ParisParis, FranceNot yet recruiting
- Centre Hospitalier Universitaire de RennesRennes, FranceNot yet recruiting
- Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex 2, FranceNot yet recruiting
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Trial code
- NCT07335562EU 2025-524337-11-00
- Record updated
- 18 September 2026
- Original description
The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic SclerosisRead full original descriptionShow less
A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (Breakfree-SSc)
The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis
Inclusion: Participants must fulfill the 2013 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria for Systemic Sclerosis (SSc), and additionally have the following:; Positive Antinuclear Antibodies (ANA) with nucleolar pattern and/or anti-Topoisomerase I (anti-Scl-70) antibodies; Confirmation of Interstitial Lung Disease (ILD) on centrally read High-Resolution Computed Tomography (HRCT) with ≥ 10% total lung involvement, with at least one of the following attributed to active SSc:; Arthritis; Myositis; Carditis; Progressive skin disease; Elevated inflammatory markers; Participants must have a non-response or intolerance despite ≥ 6 months of treatment with at least one immunomodulatory drug. Non-response is defined as a patient, who in the opinion of the investigator, is not adequately controlled/treated and requires treatment escalation.
Exclusion: Participants must not have pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral corticosteroids, cigarette smoking (including e-cigarettes) within 3 months before screening or unwilling to avoid smoking throughout the study, and/or clinically significant abnormalities on HRCT not attributable to SSc assessed by the central reader at screening; Participants must not have moderate to severe Pulmonary Arterial Hypertension (PAH) requiring PAH-specific combination treatment; Participants must not have a requirement for supplemental oxygen therapy and/or Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) ≤ 40% (Hemoglobin (Hgb) corrected) at screening; Participants must not have gastrointestinal (GI) dysmotility requiring Total Parenteral Nutrition (TPN); Participants must not have current gangrene of a digit; Other protocol-defined Inclusion/Exclusion criteria apply.