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NCT06228924 · ClinicalTrials.gov registry record · Phase 1
Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults With PKP2 Mutation-associated ARVC
A Phase 1 study of Arrhythmogenic Right Ventricular Cardiomyopathy, sponsored by Tenaya Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 7
- Study locations
NCT06228924 is a Phase 1 study of Arrhythmogenic Right Ventricular Cardiomyopathy that is actively recruiting participants, run by Tenaya Therapeutics. The registered enrollment target is 15 participants, below the 381-participant average among 4 other Arrhythmogenic Right Ventricular Cardiomyopathy trials with a reported enrollment target (96% lower). The trial reports 7 study locations across 7 states.
The verdict
NCT06228924, a Phase 1 study of Arrhythmogenic Right Ventricular Cardiomyopathy, is actively recruiting participants, sponsored by Tenaya Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 7
- Study locations
Study Summary
This first-in-human study is designed to evaluate the safety, and preliminary efficacy (PD) of TN-401 gene therapy in adult patients with symptomatic PKP2 mutation-associated ARVC.
Conditions Studied
Interventions
- GENETIC TN-401
Study Locations (7)
California
- University of California San Francisco - San Francisco
Colorado
- University of Colorado - Anschutz Medical Campus - Aurora
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- Brigham and Women's Hospital - Boston
Minnesota
- Mayo Clinic - Rochester
New York
- NYU Langone Health - New York
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-03-26 |
| Est. Completion | 2029-10-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06228924
The ClinicalTrials.gov registry entry for NCT06228924 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 381-participant average among 4 other Arrhythmogenic Right Ventricular Cardiomyopathy trials with a reported enrollment target (96% lower). The listed sponsor is Tenaya Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Arrhythmogenic Right Ventricular Cardiomyopathy appearing as the primary indexed condition, and to 1 intervention - of which TN-401 is the first listed.
NCT06228924 reports 7 study locations spanning 7 distinct geographic areas - top geographies include California, Colorado, Maryland.
Frequently Asked Questions
What is clinical trial NCT06228924 about?
NCT06228924 is a clinical study titled "Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults With PKP2 Mutation-associated ARVC". This first-in-human study is designed to evaluate the safety, and preliminary efficacy (PD) of TN-401 gene therapy in adult patients with symptomatic PKP2 mutation-associated ARVC.
What is the current status of trial NCT06228924?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2024-03-26. Estimated completion is 2029-10-01.
What conditions does trial NCT06228924 study?
This clinical trial studies the following conditions: Arrhythmogenic Right Ventricular Cardiomyopathy.
What interventions are being tested in trial NCT06228924?
The interventions under investigation include: TN-401 (GENETIC).
Who is sponsoring clinical trial NCT06228924?
This trial is sponsored by Tenaya Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06228924 being conducted?
This trial has 7 study locations across California, Colorado, Maryland, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.