Actively Recruiting
Multi-center, Open-label, Single-ascending Dose Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM
Led by Tenaya Therapeutics · Updated on 2026-03-19
30
Participants Needed
10
Research Sites
468 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multi-center, Open-label, Single-ascending Dose Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed MYBPC3 gene mutation
- Diagnosis of hypertrophic cardiomyopathy (obstructive or nonobstructive)
- Left ventricular ejection fraction of 45% or higher
- New York Heart Association Functional Class II or III symptoms
- NT-proBNP level of 160 pg/ml or higher
You will not qualify if you...
- High neutralizing antibody levels against the adeno-associated virus serotype 9 (AAV9)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
UC San Diego Altman Clinical and Translational Research Institute - Center for Clinical Research
La Jolla, California, United States, 92093
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94117
Actively Recruiting
3
Emory University
Atlanta, Georgia, United States, 30322
Withdrawn
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Withdrawn
5
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
6
The Christ Hospital Physicians - The Ohio Heart and Vascular Center
Cincinnati, Ohio, United States, 45219
Withdrawn
7
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
Oregon Health & Science University
Portland, Oregon, United States, 97239
Withdrawn
9
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Withdrawn
10
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Matt Pollman, M.D.
CONTACT
L
LaTanya Tomlinson, RN, MHSA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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