TN-201 for Hypertrophic Cardiomyopathy
(MyPEAK-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, TN-201, in adults with a specific genetic heart condition. It aims to see if the drug is safe and how it affects their health over several years.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is TN-201 safe for use in humans?
How is the treatment TN-201 for Hypertrophic Cardiomyopathy different from other treatments?
What data supports the effectiveness of the treatment TN-201 for Hypertrophic Cardiomyopathy?
Research shows that gene therapy using adeno-associated virus (AAV) vectors, like those in TN-201, has been effective in preventing heart problems in mice with similar genetic heart conditions. Specifically, AAV9 has been shown to deliver genes effectively to heart cells, which is promising for treating hypertrophic cardiomyopathy.12458
Are You a Good Fit for This Trial?
This trial is for adults with symptomatic nonobstructive hypertrophic cardiomyopathy (nHCM) linked to MYBPC3 mutation. Participants must have certain heart function markers like NT-proBNP levels of at least 300pg/ml and a left ventricular ejection fraction of 50% or more, as well as an implantable cardiac defibrillator.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single ascending dose of TN-201 Gene Therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are followed for 5 years to assess long-term safety and efficacy
What Are the Treatments Tested in This Trial?
Interventions
- TN-201
TN-201 is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tenaya Therapeutics
Lead Sponsor