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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
Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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
Official title: 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)
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2026-04-30
Completion Date
2030-11-11
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
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
Locations (54)
Local Institution - 0035
Scottsdale, Arizona, United States
Local Institution - 0092
Aurora, Colorado, United States
Local Institution - 0001
Denver, Colorado, United States
Local Institution - 0069
Miami, Florida, United States
Local Institution - 0014
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 - 0002
Charleston, South Carolina, United States
Local Institution - 0074
Dallas, Texas, United States
Local Institution - 0008
Seattle, Washington, United States
Local Institution - 0003
Antwerp, Flanders, Belgium
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