Organic Cabaletta
RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis
Generalized Myasthenia Gravis (gMG)
CABA-201
PHASE1
PHASE2
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.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 12 participants |
Masking : | NONE |
Primary Purpose : | TREATMENT |
Official Title : | 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 |
Actual Study Start Date : | 2024-10 |
Estimated Primary Completion Date : | 2029-09 |
Estimated Study Completion Date : | 2029-09 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 70 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of California Irvine
Orange, California, United States, 92868
RECRUITING
UC Davis, Department of Neurology
Sacramento, California, United States, 95817
RECRUITING
Houston Methodist Hospital
Houston, Texas, United States, 77030