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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 is a Phase 1 study that has completed, run by Cabaletta Bio. The registered enrollment target is 7 participants.

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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.

Interventions

  • BIOLOGICAL MuSK-CAART

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2022-11-23
Est. Completion 2025-07-24
Phase Phase 1

Sponsor

Cabaletta Bio

6 total trials

What the Registry Record Tells You About NCT05451212

The ClinicalTrials.gov registry entry for NCT05451212 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cabaletta Bio, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which MuSK-CAART is the first listed.

NCT05451212 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.