NCT06228924 Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults With PKP2 Mutation-associated ARVC
| NCT ID | NCT06228924 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Tenaya Therapeutics |
| Condition | Arrhythmogenic Right Ventricular Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-03-26 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2024-03-26 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * PKP2 mutation (pathogenic or likely pathogenic) * Arrhythmogenic Right Ventricular Cardiomyopathy as defined by the 2010 revised Task Force Criteria * Left Ventricular Ejection Fraction ≥50% * Functioning Implantable Cardiac Defibrillator with remote integration capabilities at least 9 months prior to Screening * NYHA Functional Class I, II, or III * Frequent premature ventricular contractions (PVCs) Exclusion Criteria: * Ventricular tachycardia (VT) ablation within 6 months of Screening or planned VT ablation within 6 months after Screening * High AAV9 neutralizing antibody titer * Prior myocardial infarction * Right Ventricular Heart Failure * Class IV Heart Failure * Clinically significant renal disease * Clinically significant liver disease
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06228924 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Arrhythmogenic Right Ventricular Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06228924 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06228924 currently recruiting?
Yes, NCT06228924 is actively recruiting participants. Contact the research team at mpollman@tenayathera.com for enrollment information.
Where is the NCT06228924 trial being conducted?
This trial is being conducted at San Francisco, United States, Aurora, United States, Baltimore, United States, Boston, United States and 3 additional locations.
Who is sponsoring the NCT06228924 clinical trial?
NCT06228924 is sponsored by Tenaya Therapeutics. The trial plans to enroll 15 participants.