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Clinical Trials in the UK / NCT07335562
Starting soon Phase 3

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

NCT07335562 · tracked via the Priya Life Science UK tracker
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Phase
Phase 3
Started
2026-08-29
Last updated
2026-08-03

Condition(s) studied

Systemic Sclerosis

Investigational drug(s) / intervention(s)

BMS-986353FludarabineCyclophosphamideTocilizumabRituximabNintedanib

BMS-986353: Specified dose on specified days

Fludarabine: Specified dose on specified days

Cyclophosphamide: Specified dose on specified days

Tocilizumab: Specified dose on specified days

Rituximab: Specified dose on specified days

Nintedanib: Specified dose on specified days

Study 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

Sex
ALL
Min age
16 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
Local Institution - 0035 Scottsdale Arizona
University of Colorado Anschutz Medical Campus Aurora Colorado
Local Institution - 0001 Denver Colorado
Local Institution - 0069 Miami Florida
Emory University School of Medicine Atlanta Georgia
Local Institution - 0139 Chicago Illinois
Local Institution - 0084 Worcester Massachusetts
Local Institution - 0034 Ann Arbor Michigan
Local Institution - 0037 Rochester Minnesota
Local Institution - 0082 Summit New Jersey
Cleveland Clinic Cleveland Ohio
Local Institution - 0142 Philadelphia Pennsylvania
Local Institution - 0143 Pittsburgh Pennsylvania
Local Institution - 0002 Charleston South Carolina
Local Institution - 0074 Dallas Texas
Local Institution - 0144 Houston Texas
Local Institution - 0008 Seattle Washington
Local Institution - 0057 Leuven Vlaams-Brabant
Local Institution - 0080 Liège Belgium
Local Institution - 0104 Halifax Nova Scotia
Local Institution - 0088 Sherbrooke Quebec
Local Institution - 0031 Strasbourg Alsace
Local Institution - 0061 Toulouse Haute-Garonne
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
Local Institution - 0004 Milan Milano
Local Institution - 0108 Pisa Tuscany
Local Institution - 0106 Milan Italy
Local Institution - 0026 Sapporo Hokkaido
Local Institution - 0132 Yokohama Kanagawa

+ 16 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07335562 on ClinicalTrials.gov ↗ ← All trials in the UK