Phase 2 Study of Rapcabtagene Autoleucel in Myositis

Running, not enrolling · Phase 2

Conditions studied: Idiopathic Inflammatory Myopathies

In brief

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 facts

Study ID

NCT06665256

Run by

Novartis Pharmaceuticals

People needed

21

Starts

2024-12-17

Expected to finish

2032-11-29

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

Where it is running

• FL Medical Clinic Orlando Health — Zephyrhills, Florida, United States
• Augusta University Georgia — Augusta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University Of Iowa — Iowa City, Iowa, United States
• Duke Clinical Research Institute — Durham, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• LDS Hospital — Salt Lake City, Utah, United States
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Barretos, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Brest, France
• Novartis Investigative Site — Lille, France
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Marseille, 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
• University Of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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