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NCT07335562PHASE3Recruiting

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

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

Start Date

8/29/2026

Completion Date

11/11/2030

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

Detailed Description

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

Eligibility Criteria

Age Range: 16 years to No maximum

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.

Interventions

DRUG

BMS-986353

DRUG

Fludarabine

DRUG

Cyclophosphamide

DRUG

Tocilizumab

DRUG

Rituximab

DRUG

Nintedanib

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Conditions

Systemic Sclerosis

Locations

Local Institution - 0035

Scottsdale, Arizona 85259

United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado 80045

United States

Local Institution - 0001

Denver, Colorado 80218

United States

Local Institution - 0069

Miami, Florida 33136

United States

Emory University School of Medicine

Atlanta, Georgia 30322

United States

Local Institution - 0139

Chicago, Illinois 60611

United States

Local Institution - 0084

Worcester, Massachusetts 01655

United States

Local Institution - 0034

Ann Arbor, Michigan 48109

United States

Local Institution - 0037

Rochester, Minnesota 55905

United States

Local Institution - 0082

Summit, New Jersey 07901

United States

Local Institution - 0122

Cleveland, Ohio 44195

United States

Local Institution - 0142

Philadelphia, Pennsylvania 19104

United States

Local Institution - 0143

Pittsburgh, Pennsylvania 15224

United States

Local Institution - 0002

Charleston, South Carolina 29425

United States

Local Institution - 0074

Dallas, Texas 75390

United States

Local Institution - 0144

Houston, Texas 77030

United States

Local Institution - 0008

Seattle, Washington 98109

United States

Local Institution - 0057

Leuven, Vlaams-Brabant 3000

Belgium

Local Institution - 0080

Liège, 4000

Belgium

Local Institution - 0104

Halifax, Nova Scotia B3H2Y9

Canada

Local Institution - 0088

Sherbrooke, Quebec J1H 5N4

Canada

Local Institution - 0031

Strasbourg, Alsace 67098

France

Local Institution - 0061

Toulouse, Haute-Garonne 31059

France

Local Institution - 0049

Bordeaux, 33076

France

Local Institution - 0012

Bron, 69500

France

Local Institution - 0052

Paris, 75679

France

Local Institution - 0141

Rennes, 35033

France

Local Institution - 0046

Berlin, 10117

Germany

Local Institution - 0016

Cologne, 50937

Germany

Local Institution - 0028

Erlangen, 91054

Germany

Local Institution - 0042

Leipzig, 04103

Germany

Local Institution - 0032

München, 80336

Germany

Local Institution - 0033

Tübingen, 72076

Germany

Local Institution - 0038

Würzburg, 97080

Germany

Local Institution - 0103

Rome, Lazio 00168

Italy

Local Institution - 0004

Milan, Milano 20162

Italy

Local Institution - 0108

Pisa, Tuscany 56126

Italy

Local Institution - 0106

Milan, 20132

Italy

Local Institution - 0026

Sapporo, Hokkaido 0608648

Japan

Local Institution - 0132

Yokohama, Kanagawa 236-0004

Japan

Local Institution - 0137

Suita, Osaka 565-0871

Japan

Local Institution - 0117

Bunkyo-ku, Tokyo 1138603

Japan

Local Institution - 0123

Fukuoka, 812-8582

Japan

Local Institution - 0136

Maebashi, 371-8511

Japan

Local Institution - 0118

Okayama, 700-8558

Japan

Local Institution - 0129

A Coruña, A Coruña [La Coruña] 15006

Spain

Local Institution - 0138

Barcelona, Catalunya [Cataluña] 08041

Spain

Local Institution - 0060

Barcelona, 08907

Spain

Local Institution - 0009

Málaga, 29011

Spain

Local Institution - 0047

Basel, 4031

Switzerland

Local Institution - 0068

Bern, 3010

Switzerland

Local Institution - 0078

Zurich, 8091

Switzerland

Local Institution - 0140

London, London, City of NW1 2PG

United Kingdom

Local Institution - 0063

Leeds, West Yorkshire LS8 7TF

United Kingdom

Local Institution - 0091

Sheffield, Yorkshire and the Humber S102JF

United Kingdom

Local Institution - 0059

London, NW3 2QG

United Kingdom