🏛️ Verified NIH Record • Updated 2026-08-12
RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis (NCT06359041)
🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Cabaletta Bio
🩺 Plain-English Summary (8th-Grade Level)
RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (8 items).
Location: University of California Irvine — Orange, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (17 Sites)
- University of California Irvine — Orange, California
- UC Davis, Department of Neurology — Sacramento, California
- University of California, San Francisco — San Francisco, California
- University of Colorado — Aurora, Colorado
- Mayo Clinic Florida — Jacksonville, Florida
- Northwestern Memorial Hospital — Chicago, Illinois
- University of Kansas Medical Center — Kansas City, Kansas
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- University of Massachusetts Chan Medical School — Worcester, Massachusetts
- Mayo Clinic - Rochester — Rochester, Minnesota
- Columbia University — New York, New York
- University of Rochester Medical Center — Rochester, New York
- Oregon Health & Science University — Portland, Oregon
- Baylor College of Medicine Neurology Department — Houston, Texas
- Houston Methodist Hospital — Houston, Texas
- University of Texas MD Anderson Cancer Center — Houston, Texas
- Swedish Neuroscience Research — Seattle, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.