A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacaptagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis

NCT07335562 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: CA061-10052025-524337-11U1111-1330-3381
• Study Type: interventional
• Target: 92
• Locations: 10 countries
• Sites: 54

Brief 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

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

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

  At 12 months

Secondary Outcomes (15)

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

  At month 12

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

  Up to month 36

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

  Approximately 54 months

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

  Up to month 36

• The change from baseline in Scleroderma Clinical Index (ScleroID)

  Up to month 36

Study Arms (2)

Arm A: BMS-986353

EXPERIMENTAL

Drug: BMS-986353; Drug: Fludarabine; Drug: Cyclophosphamide

Arm B: Standard of Care

EXPERIMENTAL

Drug: Tocilizumab; Drug: Rituximab; Drug: Nintedanib

Interventions

BMS-986353 DRUG

Specified dose on specified days

Also known as: CC-97540

Arm A: BMS-986353

Fludarabine DRUG

Specified dose on specified days

Arm A: BMS-986353

Cyclophosphamide DRUG

Specified dose on specified days

Arm A: BMS-986353

Tocilizumab DRUG

Specified dose on specified days

Arm B: Standard of Care

Rituximab DRUG

Specified dose on specified days

Arm B: Standard of Care

Nintedanib DRUG

Specified dose on specified days

Arm B: Standard of Care

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company: lead
• Celgene Corporation: collaborator

Study Sites (54)

Local Institution - 0035

Scottsdale, Arizona, 85259, United States

Location

Local Institution - 0092

Aurora, Colorado, 80045, United States

Location

Local Institution - 0001

Denver, Colorado, 80218, United States

Location

Local Institution - 0069

Miami, Florida, 33136, United States

Location

Local Institution - 0014

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0139

Chicago, Illinois, 60611, United States

Location

Local Institution - 0084

Worcester, Massachusetts, 01655, United States

Location

Local Institution - 0034

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 0037

Rochester, Minnesota, 55905, United States

Location

Local Institution - 0082

Summit, New Jersey, 07901, United States

Location

Local Institution - 0122

Cleveland, Ohio, 44195, United States

Location

Local Institution - 0002

Charleston, South Carolina, 29425, United States

Location

Local Institution - 0074

Dallas, Texas, 75390, United States

Location

Local Institution - 0008

Seattle, Washington, 98109, United States

Location

Local Institution - 0003

Antwerp, Flanders, 2030, Belgium

Location

Local Institution - 0057

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Local Institution - 0080

Liège, 4000, Belgium

Location

Local Institution - 0104

Halifax, Nova Scotia, B3H2Y9, Canada

Location

Local Institution - 0088

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Local Institution - 0031

Strasbourg, Alsace, 67098, France

Location

Local Institution - 0061

Toulouse, Haute-Garonne, 31059, France

Location

Local Institution - 0049

Bordeaux, 33076, France

Location

Local Institution - 0012

Bron, 69500, France

Location

Local Institution - 0052

Paris, 75014, France

Location

Local Institution - 0141

Rennes, 35033, France

Location

Local Institution - 0046

Berlin, 10117, Germany

Location

Local Institution - 0016

Cologne, 50937, Germany

Location

Local Institution - 0028

Erlangen, 91054, Germany

Location

Local Institution - 0042

Leipzig, 04103, Germany

Location

Local Institution - 0032

München, 80336, Germany

Location

Local Institution - 0033

Tübingen, 72076, Germany

Location

Local Institution - 0038

Würzburg, 97080, Germany

Location

Local Institution - 0103

Rome, Lazio, 00168, Italy

Location

Local Institution - 0004

Milan, Milano, 20162, Italy

Location

Local Institution - 0108

Pisa, Tuscany, 56126, Italy

Location

Local Institution - 0106

Milan, 20132, Italy

Location

Local Institution - 0026

Sapporo, Hokkaido, 0608648, Japan

Location

Local Institution - 0132

Yokohama, Kanagawa, 236-0004, Japan

Location

Local Institution - 0137

Suita, Osaka, 565-0871, Japan

Location

Local Institution - 0117

Bunkyo-ku, Tokyo, 1138603, Japan

Location

Local Institution - 0123

Fukuoka, 812-8582, Japan

Location

Local Institution - 0136

Maebashi, 371-8511, Japan

Location

Local Institution - 0118

Okayama, 700-8558, Japan

Location

Local Institution - 0129

A Coruña, A Coruña [La Coruña], 15006, Spain

Location

Local Institution - 0138

Barcelona, Catalunya [Cataluña], 08041, Spain

Location

Local Institution - 0060

Barcelona, 08907, Spain

Location

Local Institution - 0009

Málaga, 29011, Spain

Location

Local Institution - 0047

Basel, 4031, Switzerland

Location

Local Institution - 0068

Bern, 3010, Switzerland

Location

Local Institution - 0078

Zurich, 8091, Switzerland

Location

Local Institution - 0140

London, London, City of, NW1 2PG, United Kingdom

Location

Local Institution - 0063

Leeds, West Yorkshire, LS8 7TF, United Kingdom

Location

Local Institution - 0091

Sheffield, Yorkshire and the Humber, S102JF, United Kingdom

Location

Local Institution - 0059

London, NW3 2QG, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

fludarabine; Cyclophosphamide; tocilizumab; Rituximab; nintedanib

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 13, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): November 14, 2028
• Study Completion (Estimated): November 11, 2030
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (14); CA (2); DE (7); FR (6); BE (3); CH (3); IT (4); GB (4); ES (4); JP (7)