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Systemic SclerosisPhase 3Breakfree-SScNCT07335562

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

A Phase 3 study testing BMS-986353, Fludarabine and Cyclophosphamide in people with Systemic Sclerosis, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 56 sites in 10 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Systemic Sclerosis
What is being tested?
BMS-986353, Fludarabine and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
56 sitesin 10 countries
Study dates
3 Feb 2027to 11 Nov 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

56 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

56 sites in 10 countries

United States17 sites

  • Local Institution - 0034

    Ann Arbor, Michigan, 48109

    Site 0034

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

    Arezou Khosroshahi, Site 0014, 404-778-6638

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

    Melissa Griffith, Site 0092, 720-848-7700

  • Local Institution - 0002

    Charleston, South Carolina, 29425

    Site 0002

  • Local Institution - 0139

    Chicago, Illinois, 60611

    Site 0139

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Soumya Chatterjee, Site 0122

  • Local Institution - 0074

    Dallas, Texas, 75390

    Site 0074

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Richard Nash, Site 0001, 303-981-2305

  • Local Institution - 0144

    Houston, Texas, 77030

    Site 0144

  • Local Institution - 0069

    Miami, Florida, 33136

    Site 0069

  • Local Institution - 0142

    Philadelphia, Pennsylvania, 19104

    Site 0142

  • Local Institution - 0143

    Pittsburgh, Pennsylvania, 15224

    Site 0143

  • Local Institution - 0037

    Rochester, Minnesota, 55905

    Site 0037

  • Local Institution - 0035

    Scottsdale, Arizona, 85259

    Site 0035

  • Local Institution - 0008

    Seattle, Washington, 98109

    Site 0008

  • Local Institution - 0082

    Summit, New Jersey, 07901

    Site 0082

  • Local Institution - 0084

    Worcester, Massachusetts, 01655

    Site 0084

Other trials in United States

Germany7 sites

  • Local Institution - 0046

    Berlin, 10117

    Site 0046

  • Local Institution - 0016

    Cologne, 50937

    Site 0016

  • Local Institution - 0028

    Erlangen, 91054

    Site 0028

  • Local Institution - 0042

    Leipzig, 04103

    Site 0042

  • Local Institution - 0032

    München, 80336

    Site 0032

  • Local Institution - 0033

    Tübingen, 72076

  • Local Institution - 0038

    Würzburg, 97080

    Site 0038

Other trials in Germany

Japan7 sites

  • Local Institution - 0117

    Bunkyo-ku, Tokyo, 1138603

    Site 0117

  • Local Institution - 0123

    Fukuoka, 812-8582

    Site 0123

  • Local Institution - 0136

    Maebashi, 371-8511

    Site 0136

  • Local Institution - 0118

    Okayama, 700-8558

    Site 0118

  • Local Institution - 0026

    Sapporo, Hokkaido, 0608648

    Site 0026

  • Local Institution - 0137

    Suita, Osaka, 565-0871

    Site 0137

  • Local Institution - 0132

    Yokohama, Kanagawa, 236-0004

    Site 0132

Other trials in Japan

France6 sites

  • Local Institution - 0049

    Bordeaux, 33076

    Site 0049

  • Local Institution - 0012

    Bron, 69500

    Site 0012

  • Local Institution - 0052

    Paris, 75679

    Site 0052

  • Local Institution - 0141

    Rennes, 35033

    Site 0141

  • Local Institution - 0031

    Strasbourg, Alsace, 67098

    Site 0031

  • Local Institution - 0061

    Toulouse, Haute-Garonne, 31059

    Site 0061

Other trials in France

Italy4 sites

  • Local Institution - 0004

    Milan, Milano, 20162

    Site 0004

  • Local Institution - 0106

    Milan, 20132

    Site 0106

  • Local Institution - 0108

    Pisa, Tuscany, 56126

    Site 0108

  • Local Institution - 0103

    Rome, Lazio, 00168

    Site 0103

Other trials in Italy

Spain4 sites

  • Local Institution - 0129

    A Coruña, A Coruña [La Coruña], 15006

    Site 0129

  • Local Institution - 0138

    Barcelona, Catalunya [Cataluña], 08041

    Site 0138

  • Local Institution - 0060

    Barcelona, 08907

    Site 0060

  • Local Institution - 0009

    Málaga, 29011

    Site 0009

Other trials in Spain

United Kingdom4 sites

  • Local Institution - 0063

    Leeds, North Yorkshire, LS7 4SA

    Site 0063

  • Local Institution - 0140

    London, London, City of, NW1 2PG

    Site 0140

  • Local Institution - 0059

    London, NW3 2QG

    Site 0059

  • Local Institution - 0091

    Sheffield, S10 2JF

    Site 0091

Other trials in United Kingdom

Switzerland3 sites

  • Local Institution - 0047

    Basel, 4031

    Site 0047

  • Local Institution - 0068

    Bern, 3010

    Site 0068

  • Local Institution - 0078

    Zurich, 8091

    Site 0078

Other trials in Switzerland

Belgium2 sites

  • Local Institution - 0057

    Leuven, Vlaams-Brabant, 3000

    Site 0057

  • Local Institution - 0080

    Liège, 4000

    Site 0080

Other trials in Belgium

Canada2 sites

  • Local Institution - 0104

    Halifax, Nova Scotia, B3H2Y9

  • Local Institution - 0088

    Sherbrooke, Quebec, J1H 5N4

    Site 0088

Other trials in Canada

About this study

Official title: 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

Read the detailed description

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

Medical subject headings
Scleroderma, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986353Drug

    Also called CC-97540

    Specified dose on specified days

  • FludarabineDrug

    Specified dose on specified days

  • CyclophosphamideDrug

    Specified dose on specified days

  • TocilizumabDrug

    Specified dose on specified days

  • RituximabDrug

    Specified dose on specified days

  • NintedanibDrug

    Specified dose on specified days

Study groups in NCT07335562
Study groupRoleWhat they receive
Arm A: BMS-986353ExperimentalNot described
Receives: Drug: BMS-986353; Drug: Fludarabine; Drug: Cyclophosphamide
Arm B: Standard of CareExperimentalNot described
Receives: Drug: Tocilizumab; Drug: Rituximab; Drug: Nintedanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The absolute change from baseline in Forced Vital Capacity (FVC) in mL

    Measured: At 12 months

Secondary outcomes (15)

  1. The absolute change from baseline in Modified Rodnan Skin Score (mRSS)

    Measured: At month 12

  2. The absolute change from baseline in Quantitative Interstitial Lung Disease-Whole Lung (QILD-WL) score

    Measured: Up to month 36

  3. Time to progression, defined as the time from randomization to progressive disease

    Measured: Approximately 54 months

  4. The change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue

    Measured: Up to month 36

  5. The change from baseline in Scleroderma Clinical Index (ScleroID)

    Measured: Up to month 36

  6. The change from baseline in Scleroderma Health Assessment Questionnaire - Disability Index (SHAQ-DI)

    Measured: Up to month 36

  7. The change from baseline in PROMIS-29

    Measured: Up to month 36

  8. The change from baseline in St. George's Respiratory Questionnaire (SGRQ)

    Measured: Up to month 36

  9. The change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) visual analog scale

    Measured: Up to month 36

  10. The change from baseline in EQ-5D-5L Utility Index

    Measured: Up to month 36

  11. The absolute change from baseline in FVC in mL

    Measured: Up to month 36

  12. The absolute change from baseline in FVC in mL/year

    Measured: Up to month 36

  13. The absolute change from baseline in Percent Predicted Forced Vital Capacity (ppFVC)

    Measured: Up to month 36

  14. The relative change from baseline in ppFVC

    Measured: Up to month 36

  15. The absolute change from baseline in diffusing capacity of the lung for carbon monoxide (DLCO)

    Measured: Up to month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2026
  2. Study start3 Feb 2027 (estimated)
  3. Primary completion14 Nov 2028 (estimated)
  4. Study completion11 Nov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07335562
Sponsor's protocol ID
CA061-1005
Other IDs
2025-524337-11, U1111-1330-3381, 2025
Acronym
Breakfree-SSc
Status last verified
Sep 2026
First submitted
9 Jan 2026
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BMS-986353, Fludarabine and Cyclophosphamide in people with Systemic Sclerosis, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 56 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Germany, Japan, France, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The absolute change from baseline in Forced Vital Capacity (FVC) in mL (time frame: At 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07335562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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