RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis
Start Date
12/17/2024
Completion Date
9/1/2029
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
Detailed Description
Myasthenia gravis (MG) is a rare autoimmune disorder characterized by autoantibody responses that cause defective transmission of signals at the neuromuscular junction, resulting in a distinctive pattern of weakness. Patients with generalized MG (gMG) typically experience symptoms associated with ocular disease in addition to weakness of many other voluntary muscle groups, including extremity, bulbar, and respiratory muscles. MG is considered a classic example of a B-cell mediated autoimmune disease. Currently, there are no curative treatments for MG. This study is being conducted to evaluate the safety and efficacy of an investigational cell therapy, CABA-201, that can be given to patients with gMG. A single dose of CABA-201 in combination with cyclophosphamide (CY) and fludarabine (FLU) will be evaluated. In addition, escalating doses of CABA-201 will be evaluated in patients without CY and FLU preconditioning.
Eligibility Criteria
Age Range: 18 years to 70 years
Interventions
CABA-201
CABA-201
Conditions
Locations
University of California Irvine
Orange, California 92868
United States
UC Davis, Department of Neurology
Sacramento, California 95817
United States
University of California, San Francisco
San Francisco, California 94143
United States
University of Colorado
Aurora, Colorado 80045
United States
Mayo Clinic Florida
Jacksonville, Florida 32224
United States
Northwestern Memorial Hospital
Chicago, Illinois 60611
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655
United States
Mayo Clinic - Rochester
Rochester, Minnesota 55905
United States
Columbia University
New York, New York 10032
United States
University of Rochester Medical Center
Rochester, New York 14642
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
Baylor College of Medicine Neurology Department
Houston, Texas 77030
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Swedish Neuroscience Research
Seattle, Washington 98122
United States