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 (Breakfree-SSc)

July 31, 2026 updated by: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants in Arm B may receive BMS-986353 following confirmation of progression on standard of care.

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Local Institution - 0080
        • Contact:
          • Site 0080
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Local Institution - 0057
        • Contact:
          • Site 0057
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H2Y9
        • Local Institution - 0104
        • Contact:
          • Site 0104
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Local Institution - 0088
        • Contact:
          • Site 0088
  • France
      • Bordeaux, France, 33076
        • Local Institution - 0049
        • Contact:
          • Site 0049
      • Bron, France, 69500
        • Local Institution - 0012
        • Contact:
          • Site 0012
      • Paris, France, 75679
        • Local Institution - 0052
        • Contact:
          • Site 0052
      • Rennes, France, 35033
        • Local Institution - 0141
        • Contact:
          • Site 0141
    • Alsace
      • Strasbourg, Alsace, France, 67098
        • Local Institution - 0031
        • Contact:
          • Site 0031
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Local Institution - 0061
        • Contact:
          • Site 0061
  • Germany
      • Berlin, Germany, 10117
        • Local Institution - 0046
        • Contact:
          • Site 0046
      • Cologne, Germany, 50937
        • Local Institution - 0016
        • Contact:
          • Site 0016
      • Erlangen, Germany, 91054
        • Local Institution - 0028
        • Contact:
          • Site 0028
      • Leipzig, Germany, 04103
        • Local Institution - 0042
        • Contact:
          • Site 0042
      • München, Germany, 80336
        • Local Institution - 0032
        • Contact:
          • Site 0032
      • Tübingen, Germany, 72076
        • Local Institution - 0033
        • Contact:
          • Site 0033
      • Würzburg, Germany, 97080
        • Local Institution - 0038
        • Contact:
          • Site 0038
  • Italy
      • Milan, Italy, 20132
        • Local Institution - 0106
        • Contact:
          • Site 0106
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Local Institution - 0103
        • Contact:
          • Site 0103
    • Milano
      • Milan, Milano, Italy, 20162
        • Local Institution - 0004
        • Contact:
          • Site 0004
    • Tuscany
      • Pisa, Tuscany, Italy, 56126
        • Local Institution - 0108
        • Contact:
          • Site 0108
  • Japan
      • Fukuoka, Japan, 812-8582
        • Local Institution - 0123
        • Contact:
          • Site 0123
      • Maebashi, Japan, 371-8511
        • Local Institution - 0136
        • Contact:
          • Site 0136
      • Okayama, Japan, 700-8558
        • Local Institution - 0118
        • Contact:
          • Site 0118
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0608648
        • Local Institution - 0026
        • Contact:
          • Site 0026
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0004
        • Local Institution - 0132
        • Contact:
          • Site 0132
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Local Institution - 0137
        • Contact:
          • Site 0137
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138603
        • Local Institution - 0117
        • Contact:
          • Site 0117
  • Spain
      • Barcelona, Spain, 08907
        • Local Institution - 0060
        • Contact:
          • Site 0060
      • Málaga, Spain, 29011
        • Local Institution - 0009
        • Contact:
          • Site 0009
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spain, 15006
        • Local Institution - 0129
        • Contact:
          • Site 0129
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08041
        • Local Institution - 0138
        • Contact:
          • Site 0138
  • Switzerland
      • Basel, Switzerland, 4031
        • Local Institution - 0047
        • Contact:
          • Site 0047
      • Bern, Switzerland, 3010
        • Local Institution - 0068
        • Contact:
          • Site 0068
      • Zurich, Switzerland, 8091
        • Local Institution - 0078
        • Contact:
          • Site 0078
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Local Institution - 0059
        • Contact:
          • Site 0059
      • Sheffield, United Kingdom, S10 2JF
        • Local Institution - 0091
        • Contact:
          • Site 0091
    • London, City of
      • London, London, City of, United Kingdom, NW1 2PG
        • Local Institution - 0140
        • Contact:
          • Site 0140
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS8 7TF
        • Local Institution - 0063
        • Contact:
          • Site 0063
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Local Institution - 0035
        • Contact:
          • Site 0035
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
        • Contact:
          • Melissa Griffith, Site 0092
          • Phone Number: 720-848-7700
      • Denver, Colorado, United States, 80218
        • Local Institution - 0001
        • Contact:
          • Site 0001
    • Florida
      • Miami, Florida, United States, 33136
        • Local Institution - 0069
        • Contact:
          • Site 0069
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine
        • Contact:
          • Arezou Khosroshahi, Site 0014
          • Phone Number: 404-778-6638
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Local Institution - 0139
        • Contact:
          • Site 0139
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Local Institution - 0084
        • Contact:
          • Site 0084
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Local Institution - 0034
        • Contact:
          • Site 0034
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Local Institution - 0037
        • Contact:
          • Site 0037
    • New Jersey
      • Summit, New Jersey, United States, 07901
        • Local Institution - 0082
        • Contact:
          • Site 0082
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
        • Contact:
          • Soumya Chatterjee, Site 0122
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 0142
        • Contact:
          • Site 0142
      • Pittsburgh, Pennsylvania, United States, 15224
        • Local Institution - 0143
        • Contact:
          • Site 0143
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Local Institution - 0002
        • Contact:
          • Site 0002
    • Texas
      • Dallas, Texas, United States, 75390
        • Local Institution - 0074
        • Contact:
          • Site 0074
      • Houston, Texas, United States, 77030
        • Local Institution - 0144
        • Contact:
          • Site 0144
    • Washington
      • Seattle, Washington, United States, 98109
        • Local Institution - 0008
        • Contact:
          • Site 0008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: BMS-986353
Drug: Cyclophosphamide
Specified dose on specified days
Drug: Fludarabine
Specified dose on specified days
Drug: BMS-986353
Specified dose on specified days
Other Names:
  • CC-97540
Experimental: Arm B: Standard of Care
Drug: Rituximab
Specified dose on specified days
Drug: Tocilizumab
Specified dose on specified days
Drug: Nintedanib
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The absolute change from baseline in Forced Vital Capacity (FVC) in mL
Time Frame: At 12 months
At 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The absolute change from baseline in Modified Rodnan Skin Score (mRSS)
Time Frame: At month 12
At month 12
The absolute change from baseline in Quantitative Interstitial Lung Disease-Whole Lung (QILD-WL) score
Time Frame: Up to month 36
Up to month 36
Time to progression, defined as the time from randomization to progressive disease
Time Frame: Approximately 54 months
Approximately 54 months
The change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue
Time Frame: Up to month 36
Up to month 36
The change from baseline in Scleroderma Clinical Index (ScleroID)
Time Frame: Up to month 36
Up to month 36
The change from baseline in Scleroderma Health Assessment Questionnaire - Disability Index (SHAQ-DI)
Time Frame: Up to month 36
Up to month 36
The change from baseline in PROMIS-29
Time Frame: Up to month 36
Up to month 36
The change from baseline in St. George's Respiratory Questionnaire (SGRQ)
Time Frame: Up to month 36
Up to month 36
The change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) visual analog scale
Time Frame: Up to month 36
Up to month 36
The change from baseline in EQ-5D-5L Utility Index
Time Frame: Up to month 36
Up to month 36
The absolute change from baseline in FVC in mL
Time Frame: Up to month 36
Up to month 36
The absolute change from baseline in FVC in mL/year
Time Frame: Up to month 36
Up to month 36
The absolute change from baseline in Percent Predicted Forced Vital Capacity (ppFVC)
Time Frame: Up to month 36
Up to month 36
The relative change from baseline in ppFVC
Time Frame: Up to month 36
Up to month 36
The absolute change from baseline in diffusing capacity of the lung for carbon monoxide (DLCO)
Time Frame: Up to month 36
Up to month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Celgene Corporation

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 29, 2026

Primary Completion (Estimated)

November 14, 2028

Study Completion (Estimated)

November 11, 2030

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA061-1005
  • 2025-524337-11 (Other Identifier: EU CT Number)
  • U1111-1330-3381 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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