RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis
Condition(s) studied
Investigational drug(s) / intervention(s)
CABA-201: Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
CABA-201: Single intravenous infusion of CABA-201 at escalating dose levels without preconditioning
Study 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
Primary outcome measure(s)
- To evaluate incidence and severity of adverse events (AEs) — Up to 28 days after CABA-201 infusion
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal result of an investigation), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. The term AE is used to include both serious and non-serious AEs.
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California Irvine | Orange | California | Recruiting |
| UC Davis, Department of Neurology | Sacramento | California | Recruiting |
| University of California, San Francisco | San Francisco | California | Recruiting |
| University of Colorado | Aurora | Colorado | Recruiting |
| Mayo Clinic Florida | Jacksonville | Florida | Recruiting |
| Northwestern Memorial Hospital | Chicago | Illinois | Recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | Recruiting |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | Recruiting |
| Mayo Clinic - Rochester | Rochester | Minnesota | Recruiting |
| Columbia University | New York | New York | Recruiting |
| University of Rochester Medical Center | Rochester | New York | Recruiting |
| Oregon Health & Science University | Portland | Oregon | Recruiting |
| Baylor College of Medicine Neurology Department | Houston | Texas | Recruiting |
| Houston Methodist Hospital | Houston | Texas | Recruiting |
| University of Texas MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Swedish Neuroscience Research | Seattle | Washington | Recruiting |
More Cabaletta Bio trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06359041 on ClinicalTrials.gov ↗ ← All trials in the USA