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Gene Therapy
TN-201 for Hypertrophic Cardiomyopathy (MyPEAK-1 Trial)
Phase 1
Recruiting
Research Sponsored by Tenaya Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Nonobstructive Hypertrophic Cardiomyopathy
MYBPC3 mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
MyPEAK-1 Trial Summary
This trial studies a new drug to treat a type of heart disease in adults. It will evaluate how safe and effective the drug is.
Who is the study for?
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.Check my eligibility
What is being tested?
The study is testing TN-201, a new treatment for nHCM. It's the first time this drug is being given to humans. The trial will look at how safe it is, how well people can tolerate it, and what effects it has on the body.See study design
What are the potential side effects?
Since TN-201 is new and this is its first use in humans, potential side effects are not yet fully known. However, participants will be closely monitored for any signs of organ inflammation, allergic reactions or other adverse events.
MyPEAK-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a thickened heart muscle that isn't blocking blood flow.
Select...
I have a MYBPC3 gene mutation.
Select...
I have moderate to moderately severe heart symptoms.
Select...
I have a working heart defibrillator and moderate heart symptoms.
MyPEAK-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number and severity of Adverse Events over the course of the study.
Number of Serious Adverse Events related to study drug.
Secondary outcome measures
Change from baseline to Week 52 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS).
Other outcome measures
Change from Pre-dose in N-terminal pro B-type natriuretic peptide (NTproBNP), and high-sensitivity cardiac troponin I (hs-cTnI) levels.
Change from baseline in echocardiography measurement of e/e' ratio.
Change from baseline in echocardiography measurement of left ventricular mass index (g/m^2).
+3 moreMyPEAK-1 Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Dose for Cohort 2 will be 6E13 vg/kg
Group II: Cohort 1Experimental Treatment1 Intervention
Dose for Cohort 1 will be 3E13 vg/kg
Find a Location
Who is running the clinical trial?
Tenaya TherapeuticsLead Sponsor
3 Previous Clinical Trials
415 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart pumps blood out normally.Your NT-proBNP level is higher than 300pg/ml.I have a thickened heart muscle that isn't blocking blood flow.I have a MYBPC3 gene mutation.I have moderate to moderately severe heart symptoms.You have a working implantable cardiac defibrillator.I have a working heart defibrillator and moderate heart symptoms.You have a high level of AAV9 neutralizing antibodies in your blood.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elucidate on the safety of Cohort 1 for individuals?
"As this is a Phase 1 medical trial, the safety of Cohort 1 is evaluated as low with a score of one due to limited data available on its efficacy and security."
Answered by AI
Are individuals aged 50 and above eligible to participate in this investigation?
"According to the study's prerequisites, only participants aged 18-65 are eligible for this clinical trial. For those under 18 and over 65, there are 26 studies and 203 studies respectively they may be interested in."
Answered by AI
Is it possible to embark on this experiment at the present moment?
"Contrary to what clinicaltrials.gov suggests, this experiment is not recruiting participants at present. The initial post date was June 1st 2023 and the latest edit was April 18th of that same year. However, there are an abundance of other medical studies actively searching for volunteers now."
Answered by AI
Would I be eligible to participate in this clinical trial?
"To qualify for this trial, individuals must suffer from hypertrophic cardiomyopathy and fall within the age bracket of 18 to 65 years old. As such, only 15 applicants can join in total."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of California San Francisco
Hospital of the University of Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
This trial appears to be a groundbreaking therapy that could change the course of my disease.
PatientReceived 1 prior treatment
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