RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis
Part of paid clinical trials in Orange, California.
- Sponsor
- Cabaletta Bio
- Study ID
- NCT06359041
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Generalized Myasthenia Gravis (gMG)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- CABA-201 — BIOLOGICALSingle intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
- CABA-201 — BIOLOGICALSingle intravenous infusion of CABA-201 at escalating dose levels without preconditioning
Study Details
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 Dates
- First listed
- Apr 11, 2024
- Start date
- Dec 17, 2024
- Status verified
- Aug 2026
- Primary completion
- Sep 30, 2029
- Completion
- Sep 30, 2029
Study Design
- Enrollment
- 24 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: CABA-201AChR Antibody-Positive Cohort or AChR Antibody-Negative Cohort
- Experimental: CABA-201, No PreconditioningInfusion of CABA-201 with no preconditioning in subjects with gMG
Primary Outcome Measure
To evaluate incidence and severity of adverse events (AEs) [ Time Frame: Up to 28 days after CABA-201 infusion ]
Central Contacts
- Cabaletta Bio267 759 3100
Locations (17)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868 | Ali Habib, MD (PRINCIPAL_INVESTIGATOR) |
| UC Davis, Department of Neurology | Sacramento | California | 95817 | David Richman, MD (PRINCIPAL_INVESTIGATOR) |
| University of California, San Francisco | San Francisco | California | 94143 | Dr. Min Kang, MD (PRINCIPAL_INVESTIGATOR) |
| University of Colorado | Aurora | Colorado | 80045 | Alyssa Alviez Amanda Piquet, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | Dr. Jaimin Shah, MD (PRINCIPAL_INVESTIGATOR) |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | Dr. Arjun Seth, MD (PRINCIPAL_INVESTIGATOR) |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | Mazen Dimachkie, MD (PRINCIPAL_INVESTIGATOR) |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Pushpa Narayanaswami, MD (PRINCIPAL_INVESTIGATOR) |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01655 | Dr. Margaret A. Owegi, DO (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | Elie Naddaf, M.D. (PRINCIPAL_INVESTIGATOR) |
| Columbia University | New York | New York | 10032 | Dr. Christina Ulane, MD (PRINCIPAL_INVESTIGATOR) |
| University of Rochester Medical Center | Rochester | New York | 14642 | Dr. Alexis Lizarraga, MD, MS (PRINCIPAL_INVESTIGATOR) |
| Oregon Health & Science University | Portland | Oregon | 97239 | Dr. Nizar Chahin, M.D. (PRINCIPAL_INVESTIGATOR) |
| Baylor College of Medicine Neurology Department | Houston | Texas | 77030 | Milvia Pleitez, MD (PRINCIPAL_INVESTIGATOR) |
| Houston Methodist Hospital | Houston | Texas | 77030 | Dr. Sheetal Shroff, MD (PRINCIPAL_INVESTIGATOR) |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Uday Popat, MD (PRINCIPAL_INVESTIGATOR) |
| Swedish Neuroscience Research | Seattle | Washington | 98122 | Mark Loreen Dr. Christyn Edmundson, MD (PRINCIPAL_INVESTIGATOR) |
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