Clinical trial
Phase 3
Interventional
Ages 16 and up
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
Run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · NCT07335562 · Data updated 2026-11-12
Not yet open. This study is not taking new participants. Its registered completion date is 2028-11-14.
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
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 92 (estimated) |
| Sponsor | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Industry-sponsored |
| Drugs / interventions | BMS-986353, Fludarabine, Cyclophosphamide, Tocilizumab, Rituximab, Nintedanib |
| Locations | 56 sites (Belgium, Canada, France, Germany, Italy, Japan, Spain, Switzerland and more) |
| Trial ID | NCT07335562 on ClinicalTrials.gov |
What this trial studies
Participants in Arm B may receive BMS-986353 following confirmation of progression on standard of care.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria \- 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. Exclusion Criteria * 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's running
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Local Institution - 0035
Scottsdale, Arizona, United States -
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States -
Colorado Blood Cancer Institute
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
Show 44 more locations
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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 - 0052
Paris, France -
Local Institution - 0141
Rennes, France -
Local Institution - 0046
Berlin, Germany -
Local Institution - 0016
Cologne, Germany -
Local Institution - 0028
Erlangen, Germany -
Local Institution - 0042
Leipzig, Germany -
Local Institution - 0032
München, Germany -
Local Institution - 0033
Tübingen, Germany -
Local Institution - 0038
Würzburg, Germany -
Local Institution - 0103
Rome, Lazio, Italy -
Local Institution - 0004
Milan, Milano, Italy -
Local Institution - 0108
Pisa, Tuscany, Italy -
Local Institution - 0106
Milan, Italy -
Local Institution - 0026
Sapporo, Hokkaido, Japan -
Local Institution - 0132
Yokohama, Kanagawa, Japan -
Local Institution - 0137
Suita, Osaka, Japan -
Local Institution - 0117
Bunkyo-ku, Tokyo, Japan -
Local Institution - 0123
Fukuoka, Japan -
Local Institution - 0136
Maebashi, Japan -
Local Institution - 0118
Okayama, Japan -
Local Institution - 0129
A Coruña, A Coruña [La Coruña], Spain -
Local Institution - 0138
Barcelona, Catalunya [Cataluña], Spain -
Local Institution - 0060
Barcelona, Spain -
Local Institution - 0009
Málaga, Spain -
Local Institution - 0047
Basel, Switzerland
+6 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Bristol-Myers Squibb — Bristol-Myers Squibb
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-15 by the Find a Trial editorial team.
Information on this page is for educational purposes and is not medical advice.
Always consult qualified healthcare professionals about clinical trial participation.