Hypertrophic Cardiomyopathy Clinical Trial

Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM

Summary

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 MYBPC3 mutation-associated nonobstructive hypertrophic cardiomyopathy (nHCM).

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Full Description

The study will consist of 2 escalating dose cohorts. The study will enroll at least 6 and as many as 15 patients. All patients will receive active drug. The study will follow patients for 5 years following a single dose of TN-201.

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Eligibility Criteria

Inclusion Criteria:

MYBPC3 mutation
Nonobstructive Hypertrophic Cardiomyopathy
Left Ventricular Ejection Fraction ≥50%
Functioning Implantable Cardiac Defibrillator
NYHA Functional Class II or III symptoms
NT-proBNP ≥300pg/ml

Exclusion Criteria:

High AAV9 neutralizing antibody titer

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 1

Estimated Enrollment:

15

Study ID:

NCT05836259

Recruitment Status:

Not yet recruiting

Sponsor:

Tenaya Therapeutics

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There are 7 Locations for this study

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Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15213, United States
Houston Methodist Hospital
Houston Texas, 77030, United States
University of Utah
Salt Lake City Utah, 84132, United States

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 1

Estimated Enrollment:

15

Study ID:

NCT05836259

Recruitment Status:

Not yet recruiting

Sponsor:


Tenaya Therapeutics

How clear is this clinincal trial information?

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