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RecruitingPhase 3NCT07335562

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, 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)

Sponsor

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

Enrollment

92 participants

Start Date

Aug 29, 2026

Study Type

INTERVENTIONAL

Conditions

Systemic Sclerosis

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

Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BMS-986353, a drug called Cyclophosphamide, and others for people with systemic sclerosis. The study is currently recruiting participants at 56 locations. People eligible for this study include aged 16 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBMS-986353

Specified dose on specified days

DRUGFludarabine

Specified dose on specified days

DRUGCyclophosphamide

Specified dose on specified days

DRUGTocilizumab

Specified dose on specified days

DRUGRituximab

Specified dose on specified days

DRUGNintedanib

Specified dose on specified days

Locations(56)

Local Institution - 0035

Scottsdale, Arizona, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Local Institution - 0001

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

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

Local Institution - 0122

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

Local Institution - 0068

Bern, Switzerland

Local Institution - 0078

Zurich, Switzerland

Local Institution - 0140

London, London, City of, United Kingdom

Local Institution - 0063

Leeds, West Yorkshire, United Kingdom

Local Institution - 0091

Sheffield, Yorkshire and the Humber, United Kingdom

Local Institution - 0059

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT07335562

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