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
- Leuven and Liège, BelgiumSee the 2 sites
- Phase
- Phase 3
Where in Belgium
- UZ LeuvenLeuven, BelgiumNot yet recruiting
- Centre Hospitalier Universitaire de LiègeLiège, BelgiumNot 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?
Trial 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.