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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Generalized Myasthenia Gravis (gMG)

In brief

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

Key facts

Study ID

NCT06359041

Run by

Cabaletta Bio

People needed

12

Starts

2024-12-17

Expected to finish

2029-09-01

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 and ≤70 years of age
• Diagnosis of MG with generalized muscle weakness meeting criteria as defined by the MGFA class II, III , IVa, and IVb.
• Diagnosis of seropositive (autoantibodies AChR, MuSK and/or LRP4) or seronegative MG

You may not qualify if…

• Contraindication to leukapheresis
• History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites
• Active infection requiring medical intervention at screening
• Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.
• Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures
• Significant lung or cardiac impairment
• Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• 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

Full record on ClinicalTrials.gov

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