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Tests a CAR T cell therapy against standard care in systemic sclerosis

Compares a CAR T cell treatment with standard care in people with active systemic sclerosis.

Key facts

Who runs it
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Where
Basel, Bern, and Zurich, SwitzerlandSee the 3 sitesAlso in 9 other countries, 52 sites
Trial code
Registry title
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
Status
Not yet recruiting
Phase
Phase 3
People taking part
92 people, planned
Starts
3 Feb 2027
Expected to end
11 Nov 2030
Type of study
Interventional, 2 groups
Treatments tested
  • BMS-986353
  • Fludarabine
  • Cyclophosphamide
  • Tocilizumab
  • Rituximab
  • Nintedanib
Record updated
18 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with active systemic sclerosis who also have interstitial lung disease and have not responded to, or could not tolerate, earlier medicine for their condition.

Age
16 years or older.
Sex
All sexes can join.
Disease stage
Active systemic sclerosis (meets the 2013 ACR/EULAR criteria) with interstitial lung disease on a lung CT scan covering at least 10% of the lungs. Active disease means at least one of: arthritis, myositis, carditis, progressive skin disease, or high inflammation markers.
Earlier treatment
Must have had no response to, or not tolerated, at least 6 months of treatment with at least one immunomodulatory drug.
Biomarker or test result
Positive antinuclear antibodies (ANA) with a nucleolar pattern and/or anti-Topoisomerase I (anti-Scl-70) antibodies.

Main reasons for not taking part

  • Needs extra oxygen, or lung diffusing capacity (DLCO) of 40% or lower
  • Moderate to severe pulmonary arterial hypertension needing combination treatment
  • Smoked cigarettes or e-cigarettes in the last 3 months, or unwilling to avoid smoking during the study
  • Gut problems needing total parenteral nutrition (TPN)
  • Current gangrene of a finger or toe

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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
  • 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 take part

  • 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 moderate to severe Pulmonary Arterial Hypertension (PAH) requiring PAH-specific combination treatment
  • 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 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 in Switzerland

Also in 9 other countries, 52 sites

  • BaselHospital not named in the registryContact: Site 0047No longer taking part
  • BernHospital not named in the registryContact: Site 0068No longer taking part
  • ZurichHospital not named in the registryContact: Site 0078No longer taking part

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Arm A: BMS-986353Treatment being tested

    Treatment: BMS-986353, Fludarabine, and Cyclophosphamide

  • Arm B: Standard of CareTreatment being tested

    Treatment: Tocilizumab, Rituximab, and Nintedanib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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)
Plain-language title
Tests a CAR T cell therapy against standard care in systemic sclerosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
18 September 2026