RecruitingPhase 2Phase 3NCT06154252

RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Sponsor

Cabaletta Bio

Enrollment

74 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

Dermatomyositis Idiopathic Inflammatory Myopathy Anti-synthetase Syndrome Immune-Mediated Necrotizing Myopathy Juvenile Myositis Juvenile Dermatomyositis Juvenile Polymyositis Juvenile Idiopathic Inflammatory Myopathy (JIIM)

Summary

RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Eligibility

Min Age: 6 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CABA-201 following preconditioning with fludarabine and cyclophosphamide for people with anti-synthetase syndrome, dermatomyositis, and other related conditions. The study is currently recruiting participants at 35 locations. People eligible for this study include aged 6 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

BIOLOGICALCABA-201 following preconditioning with fludarabine and cyclophosphamide

Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide

Locations(35)

University of California Irvine - Accepting Adult Patients

Orange, California, United States

University of California, San Francisco Benioff Children's Hospital - Accepting Young Adult and Juvenile Patients

San Francisco, California, United States

Children's Hospital Colorado - Accepting Juvenile Patients

Aurora, Colorado, United States

Mayo Clinic Florida - Accepting Adult Patients

Jacksonville, Florida, United States

Johns Hopkins All Children's Hospital - Accepting Juvenile Patients

St. Petersburg, Florida, United States

Children's Healthcare of Atlanta - Accepting Juvenile Patients

Atlanta, Georgia, United States

Emory University - Accepting Adult Patients

Atlanta, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago - Accepting Young Adult and Juvenile Patients

Chicago, Illinois, United States

Northwestern Memorial Hospital - Accepting Adult Patients

Chicago, Illinois, United States

The University of Chicago Medical Center - Accepting Adult and Juvenile Patients

Chicago, Illinois, United States

University of Kansas Medical Center - Accepting Adult Patients

Kansas City, Kansas, United States

National Institutes of Health - Accepting Adult and Juvenile Patients

Bethesda, Maryland, United States

Boston Children's Hospital - Accepting Young Adults and Juvenile Patients

Boston, Massachusetts, United States

University of Michigan - Accepting Young Adult and Juvenile Patients

Ann Arbor, Michigan, United States

Mayo Clinic - Accepting Adult Patients

Rochester, Minnesota, United States

Hospital for Special Surgery - Accepting Adult and Juvenile Patients

New York, New York, United States

Memorial Sloan Kettering Cancer Center - Accepting Adult and Juvenile Patients

New York, New York, United States

Children's Hospital at Montefiore - Accepting Young Adult and Juvenile Patients

The Bronx, New York, United States

University of North Carolina at Chapel Hill - Accepting Adult Patients

Chapel Hill, North Carolina, United States

Duke University Medical Center - Accepting Young Adults and Juvenile Patients

Durham, North Carolina, United States

Oregon Health & Science University - Accepting Adult Patients

Portland, Oregon, United States

Children's Hospital of Philadelphia - Accepting Young Adult and Juvenile Patients

Philadelphia, Pennsylvania, United States

UPMC Children's Hospital of Pittsburgh - Accepting Juvenile Patients

Pittsburgh, Pennsylvania, United States

UPMC Arthritis and Autoimmunity Center - Accepting Adult Patients

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center - Accepting Adult Patients

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center - Accepting Juvenile Patients

Dallas, Texas, United States

Houston Methodist Hospital - Accepting Adult Patients

Houston, Texas, United States

University of Texas MD Anderson Cancer Center - Accepting Adult Patients

Houston, Texas, United States

Primary Children's Hospital/University of Utah - Accepting Juvenile Patients

Salt Lake City, Utah, United States

Seattle Children's Research Institute - Accepting Juvenile Patients

Seattle, Washington, United States

Children's Wisconsin Pediatric Rheumatology -Accepting Young Adult and Juvenile Patients

Milwaukee, Wisconsin, United States

Kings College Hospital NHS Foundation Trust - Accepting Adult Patients

London, United Kingdom

University College London Hospitals NHS Foundation Trust - Accepting Adult Patients

London, United Kingdom

Manchester Royal Infirmary - Accepting Adult Patients

Manchester, United Kingdom

Salford Royal Hospital - Accepting Adult Patients

Salford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06154252

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