RecruitingArrhythmogenic Right Ventricular Cardiomyopathy
Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults With PKP2 Mutation-associated ARVC
Eligible age
18–65 yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Tenaya Therapeutics
You may qualify if…
- ✓ 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)
You may not qualify if…
- ✕ 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
Where it's recruiting
California
San Francisco
Colorado
Aurora
Maryland
Baltimore
Massachusetts
Boston
Minnesota
Rochester
New York
New York
Ohio
Cleveland
Source: ClinicalTrials.gov · NCT06228924 · last updated 2025-02-06