Skip to content
Bored Studies
RecruitingPhase 1

Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults With PKP2 Mutation-associated ARVC

Tenaya Therapeutics · NCT06228924

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
15
US sites recruiting
7
Study start
March 26, 2024
Record last updated
February 6, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: TN-401

Conditions: Arrhythmogenic Right Ventricular Cardiomyopathy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of California San Francisco

    San Francisco, CA 94143

    Site contact: Vasanth Vedantham, MD

  • University of Colorado - Anschutz Medical Campus

    Aurora, CO 80045

    Site contact: Matthew Taylor, MD

  • Johns Hopkins University

    Baltimore, MD 21287

    Site contact: Andreas Barth, MD

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Neal Lakdawala, MD

  • Mayo Clinic

    Rochester, MN 55905

    Site contact: John R. Giudicessi, MD

  • NYU Langone Health

    New York, NY 10016

    Site contact: Larry Chinitz, MD

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Milind Desai, MD

Study contacts (from the official record)

  • Matthew Pollman, M.D. · (650) 416-1186 · mpollman@tenayathera.com
  • Niha Kamat · clinical.trials@tenayathera.com
All heart & blood pressure studies in California →
Open-label, Dose Escalation Study of Safety and Preliminary… (NCT06228924) | Bored Studies