RecruitingPhase 1Phase 2NCT06359041

RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis

RESET-MG: 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 Participants With Generalized Myasthenia Gravis

Sponsor

Cabaletta Bio

Enrollment

24 participants

Start Date

Dec 17, 2024

Study Type

INTERVENTIONAL

Conditions

Generalized Myasthenia Gravis (gMG)

Summary

RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CABA-201 and a biological treatment called CABA-201 for people with generalized myasthenia gravis (gmg). The study is currently recruiting participants at 17 locations. People eligible for this study include aged 18 Years to 70 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

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

BIOLOGICALCABA-201

Single intravenous infusion of CABA-201 at escalating dose levels without preconditioning

Locations(17)

University of California Irvine

Orange, California, United States

UC Davis, Department of Neurology

Sacramento, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Colorado

Aurora, Colorado, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Columbia University

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

Baylor College of Medicine Neurology Department

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Swedish Neuroscience Research

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06359041

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