Multi-center, Open-label, Single-ascending Dose Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM (NCT05836259)
First-in-Human, Open-Label, Safety, Tolerability, Dose-Finding, Pharmacodynamic and Cardiac Transgene Expression Study of TN-201, a Recombinant Adeno-associated Virus Serotype 9 (AAV9) Containing Myosin Binding Protein C Transgene, in Adults With MYBPC3 Mutation-associated Hypertrophic Cardiomyopathy (HCM)
🩺 Plain-English Summary (8th-Grade Level)
This is a first-in-human, non-randomized, open-label study designed to evaluate the safety, tolerability, and pharmacodynamics (PD) of TN-201 in adult patients with symptomatic hypertrophic cardiomyopathy (HCM) caused by mutations in the MYBPC3 gene.
Who can join: Review the eligibility criteria below.
Location: UC San Diego Altman Clinical and Translational Research Institute - Center for Clinical Research — La Jolla, California
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
- TN-201 (GENETIC)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (10 Sites)
- UC San Diego Altman Clinical and Translational Research Institute - Center for Clinical Research — La Jolla, California
- University of California San Francisco — San Francisco, California
- Emory University — Atlanta, Georgia
- Brigham and Women's Hospital — Boston, Massachusetts
- Mayo Clinic — Rochester, Minnesota
- The Christ Hospital Physicians - The Ohio Heart and Vascular Center — Cincinnati, Ohio
- Cleveland Clinic — Cleveland, Ohio
- Oregon Health & Science University — Portland, Oregon
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania
- Houston Methodist Hospital — Houston, Texas
📞 Contact the Study Coordinator
Phone: (650) 209-8092
Email: mpollman@tenayathera.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hypertrophic Cardiomyopathy
- A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy — Rochester, Minnesota
- HCMR - Novel Markers of Prognosis in Hypertrophic Cardiomyopathy — New Haven, Connecticut
- A Study of Artificial Intelligence ECG With ECG Devices to Detect Hypertrophic Cardiomyopathy Distinct From Athlete's — Rochester, Minnesota
- A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM) — San Francisco, California
- Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy — San Francisco, California
- VIZ ACCESS HCM - Multi-Site Registry — Atlanta, Georgia
Explore by condition: All Hypertrophic Cardiomyopathy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.