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

PhasePhase 3
Study typeInterventional
Ages16 Years and up
SexAll
Enrollment92 (estimated)
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
Industry-sponsored
Drugs / interventionsBMS-986353, Fludarabine, Cyclophosphamide, Tocilizumab, Rituximab, Nintedanib
Locations56 sites (Belgium, Canada, France, Germany, Italy, Japan, Spain, Switzerland and more)
Trial IDNCT07335562 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

  • 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
  • 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

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. 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.