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Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis
Sponsor: Novartis Pharmaceuticals
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.
Official title: A Phase II, Multi-part, Randomized, Open-label, Assessor-blinded, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Rituximab Treatment in Participants With Severe Refractory Diffuse Cutaneous Systemic Sclerosis
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2024-10-29
Completion Date
2032-08-30
Last Updated
2026-02-20
Healthy Volunteers
No
Conditions
Interventions
rapcabtagene autoleucel
single infusion of rapcabtagene autoleucel after lymphodepleting therapy with fludarabine (adjusted based on renal impairment) and cyclophosphamide daily for 3 days.
rituximab
rituximab intravenous infusion (i.v.) as per protocol
Locations (80)
UCLA
Los Angeles, California, United States
UCSF
San Francisco, California, United States
UCSF
San Francisco, California, United States
Sutter Health Network
San Pablo, California, United States
FL Medical Clinic Orlando Health
Zephyrhills, Florida, United States
Northwestern University
Chicago, Illinois, United States
University Of Iowa
Iowa City, Iowa, United States
Boston Medical Center
Boston, Massachusetts, United States
Michigan Med University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
James Cancer Hospital
Columbus, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
Avera Cancer
Sioux Falls, South Dakota, United States
LDS Hospital
Salt Lake City, Utah, United States
Novartis Investigative Site
Camperdown, New South Wales, Australia
Novartis Investigative Site
Darlinghurst, New South Wales, Australia
Novartis Investigative Site
Graz, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Olomouc, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Aarhus N, Denmark
Novartis Investigative Site
Bordeaux, France
Novartis Investigative Site
Dijon, France
Novartis Investigative Site
Lille, France
Novartis Investigative Site
Lyon, France
Novartis Investigative Site
Montpellier, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Rennes, France
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Novartis Investigative Site
Göttingen, Lower Saxony, Germany
Novartis Investigative Site
Leipzig, Saxony, Germany
Novartis Investigative Site
Halle, Saxony-Anhalt, Germany
Novartis Investigative Site
Jena, Thuringia, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
Nuremberg, Germany
Novartis Investigative Site
Ulm, Germany
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Haifa, Israel
Novartis Investigative Site
Ramat Gan, Israel
Novartis Investigative Site
Tel Aviv, Israel
Novartis Investigative Site
Ancona, AN, Italy
Novartis Investigative Site
Bergamo, BG, Italy
Novartis Investigative Site
Brescia, BS, Italy
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Pescara, PE, Italy
Novartis Investigative Site
Perugia, PG, Italy
Novartis Investigative Site
Pisa, PI, Italy
Novartis Investigative Site
Pavia, PV, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Udine, UD, Italy
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Kanazawa, Ishikawa-ken, Japan
Novartis Investigative Site
Sendai, Miyagi, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan
Novartis Investigative Site
Fukuoka, Japan
Novartis Investigative Site
Kyoto, Japan
Novartis Investigative Site
Utrecht, Netherlands
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain
Novartis Investigative Site
Santander, Cantabria, Spain
Novartis Investigative Site
Pamplona, Navarre, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Córdoba, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Málaga, Spain
Novartis Investigative Site
Salamanca, Spain
Novartis Investigative Site
Valencia, Spain
Novartis Investigative Site
Geneva, Switzerland
Novartis Investigative Site
Lausanne, Switzerland
Novartis Investigative Site
Zurich, Switzerland
Novartis Investigative Site
Taichung, Taiwan