Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis
Start Date
10/29/2024
Completion Date
8/30/2032
Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis relative to rituximab.
Detailed Description
This is a phase 2, multi-part, five-year, randomized, open-label, assessor-blinded, multicenter study to evaluate the efficacy and safety of rapcabtagene autoleucel versus rituximab in participants with severe refractory diffuse cutaneous systemic sclerosis (dcSSc). This study comprises two cohorts: * A Lead-in Cohort enrolling participants to receive rapcabtagene autoleucel. * A Randomized Cohort enrolling participants to receive rapcabtagene autoleucel or rituximab. Participants in the rituximab arm whose disease is not fully controlled may receive rapcabtagene autoleucel treatment once the participant is confirmed to be eligible per protocol. After end of study, participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (LTFU) period after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.
Eligibility Criteria
Age Range: 18 years to 70 years
Interventions
rapcabtagene autoleucel
rituximab
Conditions
Locations
UCLA
Los Angeles, California 90095
United States
UCSF
San Francisco, California 94115
United States
UCSF
San Francisco, California 94115
United States
Sutter Health Network
San Pablo, California 94806
United States
FL Medical Clinic Orlando Health
Zephyrhills, Florida 33542
United States
Northwestern University
Chicago, Illinois 60611
United States
University Of Iowa
Iowa City, Iowa 52242
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
Michigan Med University of Michigan
Ann Arbor, Michigan 48109 5271
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
James Cancer Hospital
Columbus, Ohio 43210
United States
Oregon Health Sciences University
Portland, Oregon 97239
United States
Avera Cancer
Sioux Falls, South Dakota 57105
United States
LDS Hospital
Salt Lake City, Utah 84143
United States
Novartis Investigative Site
CABA, C1181ACH
Argentina
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Córdoba, X5016KEH
Argentina
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Camperdown, New South Wales 2050
Australia
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Darlinghurst, New South Wales 2010
Australia
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Graz, 8036
Austria
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Vienna, 1090
Austria
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Ghent, 9000
Belgium
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Salvador, Estado de Bahia 41253-190
Brazil
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Curitiba, Paraná 80030-110
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Barretos, São Paulo 14784 400
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São Paulo, São Paulo 01232-010
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São Paulo, São Paulo 01308-050
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Olomouc, 779 00
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Prague, 128 00
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Aarhus N, 8200
Denmark
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Bordeaux, 33076
France
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Dijon, 21000
France
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Lille, 59037
France
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Lyon, 69003
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Montpellier, 34295
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Paris, 75014
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Rennes, 35033
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Strasbourg, 67091
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Freiburg im Breisgau, Baden-Wurttemberg 79106
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Göttingen, Lower Saxony 37075
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Leipzig, Saxony 04103
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Halle, Saxony-Anhalt 06120
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Jena, Thuringia 07740
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Berlin, 13353
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Lübeck, 23538
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Mainz, 55131
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Nuremberg, 90419
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Ulm, 89081
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Debrecen, Hajdu Bihar Megye 4032
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Budapest, H-1083
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Haifa, 3109601
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Ramat Gan, 5265601
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Tel Aviv, 6423906
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Ancona, AN 60020
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Bergamo, BG 24127
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Brescia, BS 25123
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Genova, GE 16132
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Milan, MI 20122
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Milan, MI 20132
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Pescara, PE 65124
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Perugia, PG 06129
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Pisa, PI 56126
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Pavia, PV 27100
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Roma, RM 00168
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Udine, UD 33100
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Sapporo, Hokkaido 060-8648
Japan
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Sendai, Miyagi 9808574
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Suita, Osaka 565-0871
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Bunkyo-ku, Tokyo 113-8603
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Fukuoka, 8128582
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Ishikawa, 9208641
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Kyoto, 6068507
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Utrecht, 3584 CX
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Singapore, 169608
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Seoul, 04763
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Seoul, 06351
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Seoul, 06591
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Santiago Compostela, A Coruna 15706
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Santander, Cantabria 39008
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Pamplona, Navarre 31008
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Barcelona, 08035
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Barcelona, 08041
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Córdoba, 14004
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Madrid, 28009
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Madrid, 28041
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Málaga, 29010
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Salamanca, 37007
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Valencia, 46026
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Geneva, 1211
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Lausanne, 1011
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Zurich, 8091
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Taichung, 407219
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Sheffield, South Yorkshire S10 2JF
United Kingdom