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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified May 2026 by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Information Provided by (Responsible Party)
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Clinicaltrials.gov Identifier
NCT07335562
Other Study ID Numbers:
CA061-1005
First Submitted
January 8, 2026
First Posted
January 12, 2026
Last Update Posted
June 14, 2026
Last Verified
May 2026

ClinicalTrials.gov processed this data on June 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

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

Condition or DiseaseIntervention/Treatment
Systemic Sclerosis
Drug: BMS-986353Drug: Tocilizumab

Study Design

Study TypeInterventional
Actual Enrollment92 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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)
Study Start Date2mos 1w from now
Actual Primary Completion Date2yrs 4mos from now
Actual Study Completion Date4yrs 4mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Arm A: BMS-986353
Drug: BMS-986353
Specified dose on specified days
Arm B: Standard of Care
Drug: Tocilizumab
Specified dose on specified days

Outcome Measures

Primary Outcome Measures
  1. The absolute change from baseline in Forced Vital Capacity (FVC) in mL
Secondary Outcome Measures
  1. The absolute change from baseline in Modified Rodnan Skin Score (mRSS)
  2. The absolute change from baseline in Quantitative Interstitial Lung Disease-Whole Lung (QILD-WL) score
  3. Time to progression, defined as the time from randomization to progressive disease
  4. The change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue
  5. The change from baseline in Scleroderma Clinical Index (ScleroID)
  6. The change from baseline in Scleroderma Health Assessment Questionnaire - Disability Index (SHAQ-DI)
  7. The change from baseline in PROMIS-29
  8. The change from baseline in St. George's Respiratory Questionnaire (SGRQ)
  9. The change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) visual analog scale
  10. The change from baseline in EQ-5D-5L Utility Index
  11. The absolute change from baseline in FVC in mL
  12. The absolute change from baseline in FVC in mL/year
  13. The absolute change from baseline in Percent Predicted Forced Vital Capacity (ppFVC)
  14. The relative change from baseline in ppFVC
  15. The absolute change from baseline in diffusing capacity of the lung for carbon monoxide (DLCO)

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion 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
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.

Contacts and Locations

Sponsors and CollaboratorsJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
Locations
Local Institution - 0035 | Scottsdale Arizona, United States, 85259University of Colorado Anschutz Medical Campus | Aurora Colorado, United States, 80045Local Institution - 0001 | Denver Colorado, United States, 80218Local Institution - 0069 | Miami Florida, United States, 33136Emory University School of Medicine | Atlanta Georgia, United States, 30322Local Institution - 0139 | Chicago Illinois, United States, 60611Local Institution - 0084 | Worcester Massachusetts, United States, 01655Local Institution - 0034 | Ann Arbor Michigan, United States, 48109Local Institution - 0037 | Rochester Minnesota, United States, 55905Local Institution - 0082 | Summit New Jersey, United States, 07901Local Institution - 0122 | Cleveland Ohio, United States, 44195Local Institution - 0142 | Philadelphia Pennsylvania, United States, 19104Local Institution - 0143 | Pittsburgh Pennsylvania, United States, 15224Local Institution - 0002 | Charleston South Carolina, United States, 29425Local Institution - 0074 | Dallas Texas, United States, 75390Local Institution - 0144 | Houston Texas, United States, 77030Local Institution - 0008 | Seattle Washington, United States, 98109Local Institution - 0057 | Leuven Vlaams-Brabant, Belgium, 3000Local Institution - 0080 | Liège , Belgium, 4000Local Institution - 0104 | Halifax Nova Scotia, Canada, B3H2Y9Local Institution - 0088 | Sherbrooke Quebec, Canada, J1H 5N4Local Institution - 0031 | Strasbourg Alsace, France, 67098Local Institution - 0061 | Toulouse Haute-Garonne, France, 31059Local Institution - 0049 | Bordeaux , France, 33076Local Institution - 0012 | Bron , France, 69500Local Institution - 0052 | Paris , France, 75679Local Institution - 0141 | Rennes , France, 35033Local Institution - 0046 | Berlin , Germany, 10117Local Institution - 0016 | Cologne , Germany, 50937Local Institution - 0028 | Erlangen , Germany, 91054Local Institution - 0042 | Leipzig , Germany, 04103Local Institution - 0032 | München , Germany, 80336Local Institution - 0033 | Tübingen , Germany, 72076Local Institution - 0038 | Würzburg , Germany, 97080Local Institution - 0103 | Rome Lazio, Italy, 00168Local Institution - 0004 | Milan Milano, Italy, 20162Local Institution - 0108 | Pisa Tuscany, Italy, 56126Local Institution - 0106 | Milan , Italy, 20132Local Institution - 0026 | Sapporo Hokkaido, Japan, 0608648Local Institution - 0132 | Yokohama Kanagawa, Japan, 236-0004Local Institution - 0137 | Suita Osaka, Japan, 565-0871Local Institution - 0117 | Bunkyo-ku Tokyo, Japan, 1138603Local Institution - 0123 | Fukuoka , Japan, 812-8582Local Institution - 0136 | Maebashi , Japan, 371-8511Local Institution - 0118 | Okayama , Japan, 700-8558Local Institution - 0129 | A Coruña A Coruña [La Coruña], Spain, 15006Local Institution - 0138 | Barcelona Catalunya [Cataluña], Spain, 08041Local Institution - 0060 | Barcelona , Spain, 08907Local Institution - 0009 | Málaga , Spain, 29011Local Institution - 0047 | Basel , Switzerland, 4031Local Institution - 0068 | Bern , Switzerland, 3010Local Institution - 0078 | Zurich , Switzerland, 8091Local Institution - 0140 | London London, City of, United Kingdom, NW1 2PGLocal Institution - 0063 | Leeds West Yorkshire, United Kingdom, LS8 7TFLocal Institution - 0091 | Sheffield Yorkshire and the Humber, United Kingdom, S102JFLocal Institution - 0059 | London , United Kingdom, NW3 2QG
Investigators
Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb