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
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
Interventions
BMS-986353
Fludarabine
Cyclophosphamide
Tocilizumab
Rituximab
Nintedanib
Conditions
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