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Phase 2 Study of Rapcabtagene Autoleucel in Myositis
Sponsor: Novartis Pharmaceuticals
Summary
A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies (IIM)
Official title: A Phase 2, Randomized, Open-label, Controlled Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Comparator in Participants With Severe Refractory Idiopathic Inflammatory Myopathies (IIM)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
123
Start Date
2024-12-17
Completion Date
2030-07-17
Last Updated
2026-02-05
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.
Active Comparator Option
Investigator choice of treatment as per protocol
Locations (55)
University Of Alabama
Birmingham, Alabama, United States
FL Medical Clinic Orlando Health
Zephyrhills, Florida, United States
Northwestern University
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University Of Iowa
Iowa City, Iowa, United States
LDS Hospital
Salt Lake City, Utah, United States
Novartis Investigative Site
Brest, France
Novartis Investigative Site
Lille, France
Novartis Investigative Site
Lyon, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Rennes, France
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany
Novartis Investigative Site
Leipzig, Saxony, Germany
Novartis Investigative Site
Jena, Thuringia, Germany
Novartis Investigative Site
Aachen, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
Nuremberg, Germany
Novartis Investigative Site
Ulm, Germany
Novartis Investigative Site
Haifa, Israel
Novartis Investigative Site
Ramat Gan, Israel
Novartis Investigative Site
Tel Aviv, Israel
Novartis Investigative Site
Brescia, BS, Italy
Novartis Investigative Site
Monza, MB, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Kanazawa, Ishikawa-ken, Japan
Novartis Investigative Site
Yokohama, Kanagawa-ku, Japan
Novartis Investigative Site
Sendai, Miyagi, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Izumo, Shimane, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan
Novartis Investigative Site
Fukuoka, Japan
Novartis Investigative Site
Kyoto, Japan
Novartis Investigative Site
Amsterdam, North Holland, Netherlands
Novartis Investigative Site
Riyadh, Saudi Arabia
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore
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
Córdoba, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Málaga, Spain
Novartis Investigative Site
Salamanca, Spain
Novartis Investigative Site
Geneva, Switzerland
Novartis Investigative Site
Kaohsiung City, Taiwan
Novartis Investigative Site
Taichung, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Sheffield, South Yorkshire, United Kingdom
Novartis Investigative Site
London, United Kingdom