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NCT05451212 · ClinicalTrials.gov registry record · Phase 1
Open-label Study to Evaluate the Safety of Various Dosing Regimens of MuSK-CAART for MuSK Myasthenia Gravis
A Phase 1 study, sponsored by Cabaletta Bio.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT05451212: Completed Phase 1 study, sponsored by Cabaletta Bio.
NCT05451212 is a Phase 1 study that has completed, run by Cabaletta Bio. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05451212, a Phase 1 study, has completed, sponsored by Cabaletta Bio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Muscle-specific tyrosine kinase (MuSK) myasthenia gravis (MG) is a rare but potentially severe disease, in which patients develop pathogenic autoantibodies that specifically target the MuSK protein in the neuromuscular junction. This phase 1 study is being conducted to evaluate the safety of various dosing regimens of an investigational cell therapy, MuSK-CAART, that can be given to patients with anti-MuSK antibody positive Myasthenia Gravis (MuSK MG), who have active disease. Various dosing regimens of MuSK-CAART alone, in combination with cyclophosphamide (CY), and in combination with CY and fludarabine (FLU) will be evaluated. Treatment with MuSK-CAART may potentially lead to complete and durable remission of disease.
Primary Outcome
Incidence of adverse events (AEs), including dose-limiting toxicities (DLTs) and AEs that are related to MuSK-CAART.
Interventions
- BIOLOGICAL MuSK-CAART
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-11-23 |
| Est. Completion | 2025-07-24 |
| Phase | Phase 1 |
What the finished NCT05451212 record still lists
NCT05451212 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which MuSK-CAART is the first listed.
NCT05451212 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05451212 about?
NCT05451212 is a clinical study titled "Open-label Study to Evaluate the Safety of Various Dosing Regimens of MuSK-CAART for MuSK Myasthenia Gravis". Muscle-specific tyrosine kinase (MuSK) myasthenia gravis (MG) is a rare but potentially severe disease, in which patients develop pathogenic autoantibodies that specifically target the MuSK protein in the neuromuscular junction. This phase 1 study is being conducted to evaluate the safety of various...
What is the current status of trial NCT05451212?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2022-11-23. Estimated completion is 2025-07-24.
What interventions are being tested in trial NCT05451212?
The interventions under investigation include: MuSK-CAART (BIOLOGICAL).
Who is sponsoring clinical trial NCT05451212?
This trial is sponsored by Cabaletta Bio, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05451212's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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