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

Starting soon · Phase 3

Conditions studied: Systemic Sclerosis

In brief

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

Key facts

Study ID

NCT07335562

Run by

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

People needed

92

Starts

2026-08-29

Expected to finish

2030-11-11

Last updated by the study team

2026-08-03

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:.
• i) Positive Antinuclear Antibodies (ANA) with nucleolar pattern and/or anti-Topoisomerase I (anti-Scl-70) antibodies.
• ii) 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:.
• A. Arthritis.
• B. Myositis.
• C. Carditis.
• D. Progressive skin disease.
• E. 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.

You may not qualify if…

• 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 moderate to severe Pulmonary Arterial Hypertension (PAH) requiring PAH-specific combination treatment
• 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 gastrointestinal (GI) dysmotility requiring Total Parenteral Nutrition (TPN).
• Participants must not have current gangrene of a digit
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• Local Institution - 0001 — Denver, Colorado, United States
• Local Institution - 0069 — Miami, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Local Institution - 0139 — Chicago, Illinois, United States
• Local Institution - 0084 — Worcester, Massachusetts, United States
• Local Institution - 0034 — Ann Arbor, Michigan, United States
• Local Institution - 0037 — Rochester, Minnesota, United States
• Local Institution - 0082 — Summit, New Jersey, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Local Institution - 0142 — Philadelphia, Pennsylvania, United States
• Local Institution - 0143 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0002 — Charleston, South Carolina, United States
• Local Institution - 0074 — Dallas, Texas, United States
• Local Institution - 0144 — Houston, Texas, United States
• Local Institution - 0008 — Seattle, Washington, United States
• Local Institution - 0057 — Leuven, Vlaams-Brabant, Belgium
• Local Institution - 0080 — Liège, Belgium
• Local Institution - 0104 — Halifax, Nova Scotia, Canada
• Local Institution - 0088 — Sherbrooke, Quebec, Canada
• Local Institution - 0031 — Strasbourg, Alsace, France
• Local Institution - 0061 — Toulouse, Haute-Garonne, France
• Local Institution - 0049 — Bordeaux, France
• Local Institution - 0012 — Bron, France
• Local Institution - 0035 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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