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NCT06359041 · ClinicalTrials.gov registry record · Phase 1
RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis
A Phase 1 study of Generalized Myasthenia Gravis (gMG), sponsored by Cabaletta Bio.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 17
- Study locations
NCT06359041: Active Phase 1 study of Generalized Myasthenia Gravis (gMG), sponsored by Cabaletta Bio.
NCT06359041 is a Phase 1 study of Generalized Myasthenia Gravis (gMG) that is active but no longer recruiting, run by Cabaletta Bio. The registered enrollment target is 12 participants, below the 58-participant average among 4 other Generalized Myasthenia Gravis (gMG) trials with a reported enrollment target (79% lower). The trial reports 17 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06359041, a Phase 1 study of Generalized Myasthenia Gravis (gMG), is active but no longer recruiting, sponsored by Cabaletta Bio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 17
- Study locations
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
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL CABA-201
Study Locations (17)
California
- University of California Irvine - Orange
- UC Davis, Department of Neurology - Sacramento
- University of California, San Francisco - San Francisco
Texas
- Baylor College of Medicine Neurology Department - Houston
- Houston Methodist Hospital - Houston
- University of Texas MD Anderson Cancer Center - Houston
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- University of Massachusetts Chan Medical School - Worcester
New York
- Columbia University - New York
- University of Rochester Medical Center - Rochester
Colorado
- University of Colorado - Aurora
Florida
- Mayo Clinic Florida - Jacksonville
Illinois
- Northwestern Memorial Hospital - Chicago
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-12-17 |
| Est. Completion | 2029-09 |
| Phase | Phase 1 |
What the registry record for NCT06359041 still lists
NCT06359041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 58-participant average among 4 other Generalized Myasthenia Gravis (gMG) trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Generalized Myasthenia Gravis (gMG) appearing as the primary indexed condition, and to 1 intervention - of which CABA-201 is the first listed.
NCT06359041 lists 17 locations in 11 states (California, Texas, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06359041 about?
NCT06359041 is a clinical study titled "RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis". RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis
What is the current status of trial NCT06359041?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2024-12-17. Estimated completion is 2029-09.
What conditions does trial NCT06359041 study?
This clinical trial studies the following conditions: Generalized Myasthenia Gravis (gMG).
What interventions are being tested in trial NCT06359041?
The interventions under investigation include: CABA-201 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06359041?
This trial is sponsored by Cabaletta Bio, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06359041 being conducted?
This trial has 17 study locations across California, Colorado, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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