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Experimental cell therapy takes on hard-to-treat muscle disease

NCT ID NCT06665256

Ongoing Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new treatment called rapcabtagene autoleucel for people with severe idiopathic inflammatory myopathies (muscle inflammation) that hasn't improved with standard therapies. About 21 adults will receive either this cell therapy or a comparator. The main goal is to see if more participants achieve moderate-to-major improvement in muscle function by week 52, while also tracking safety and steroid use.

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy dermatomyositis interstitial lung disease myositis disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IDIOPATHIC INFLAMMATORY MYOPATHIES

Contacts and locations

Locations

  • Augusta University Georgia

    Augusta, Georgia, 30912, United States

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Duke Clinical Research Institute

    Durham, North Carolina, 27710, United States

  • FL Medical Clinic Orlando Health

    Zephyrhills, Florida, 33542, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • LDS Hospital

    Salt Lake City, Utah, 84143, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Novartis Investigative Site

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    Barretos, São Paulo, 14784 400, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 01232-010, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 01308-050, Brazil

  • Novartis Investigative Site

    Brest, 29200, France

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Lyon, 69003, France

  • Novartis Investigative Site

    Marseille, 13885, France

  • Novartis Investigative Site

    Paris, 75013, France

  • Novartis Investigative Site

    Rennes, 35033, France

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    Aachen, 52074, Germany

  • Novartis Investigative Site

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Nuremberg, 90419, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Haifa, 3109601, Israel

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Ancona, AN, 60126, Italy

  • Novartis Investigative Site

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    Monza, MB, 20900, Italy

  • Novartis Investigative Site

    Milan, MI, 20122, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Verona, VR, 37134, Italy

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 236-0004, Japan

  • Novartis Investigative Site

    Sendai, Miyagi, 9808574, Japan

  • Novartis Investigative Site

    Suita, Osaka, 565-0871, Japan

  • Novartis Investigative Site

    Izumo, Shimane, 6938501, Japan

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8603, Japan

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 1138519, Japan

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 1608582, Japan

  • Novartis Investigative Site

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    Ishikawa, 9208641, Japan

  • Novartis Investigative Site

    Kyoto, 6068507, Japan

  • Novartis Investigative Site

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Novartis Investigative Site

    Riyadh, 11211, Saudi Arabia

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    Singapore, S308433, Singapore

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    Santander, Cantabria, 39008, Spain

  • Novartis Investigative Site

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Málaga, 29010, Spain

  • Novartis Investigative Site

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    Geneva, 1211, Switzerland

  • Novartis Investigative Site

    Kaohsiung City, 83301, Taiwan

  • Novartis Investigative Site

    Taichung, 407219, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Sheffield, South Yorkshire, S10 2JF, United Kingdom

  • Novartis Investigative Site

    London, NW1 2BU, United Kingdom

  • University Of Alabama

    Birmingham, Alabama, 35294, United States

  • University Of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15261, United States

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