RecruitingPhase 2NCT06665256

Phase 2 Study of Rapcabtagene Autoleucel in Myositis

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)


Sponsor

Novartis Pharmaceuticals

Enrollment

123 participants

Start Date

Dec 17, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Active Comparator Option and a biological treatment called Rapcabtagene autoleucel for people with idiopathic inflammatory myopathies. The study is currently recruiting participants at 67 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRapcabtagene autoleucel

Single infusion of rapcabtagene autoleucel after lymphodepleting therapy with fludarabine (adjusted based on renal impairment) and cyclophosphamide daily for 3 days.

OTHERActive Comparator Option

Investigator choice of treatment as per protocol


Locations(68)

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

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

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Brest, France

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Lille, France

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Lyon, France

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Marseille, France

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Paris, France

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Rennes, France

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Cologne, North Rhine-Westphalia, Germany

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Leipzig, Saxony, Germany

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Jena, Thuringia, Germany

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Aachen, Germany

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Hamburg, Germany

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Mainz, Germany

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Nuremberg, Germany

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Ulm, Germany

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Haifa, Israel

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Ramat Gan, Israel

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Tel Aviv, Israel

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Ancona, AN, Italy

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Brescia, BS, Italy

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Monza, MB, Italy

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Milan, MI, Italy

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Rozzano, MI, Italy

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Verona, VR, Italy

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Sapporo, Hokkaido, Japan

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Yokohama, Kanagawa, Japan

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Sendai, Miyagi, Japan

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Suita, Osaka, Japan

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Izumo, Shimane, Japan

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Bunkyo-ku, Tokyo, Japan

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Bunkyo-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Fukuoka, Japan

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Ishikawa, Japan

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Kyoto, Japan

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Amsterdam, North Holland, Netherlands

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Riyadh, Saudi Arabia

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Singapore, Singapore

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Singapore, Singapore

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Singapore, Singapore

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Santiago Compostela, A Coruna, Spain

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Santander, Cantabria, Spain

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Pamplona, Navarre, Spain

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Barcelona, Spain

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Córdoba, Spain

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Madrid, Spain

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Madrid, Spain

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Málaga, Spain

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Salamanca, Spain

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Geneva, Switzerland

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

Novartis Investigative Site

Sheffield, South Yorkshire, United Kingdom

Novartis Investigative Site

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06665256


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