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Multi-center, Open-label, Single-ascending Dose Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM

Plain-language summary

This study evaluates the safety and tolerability of TN-201, a gene therapy, in adults with hypertrophic cardiomyopathy caused by a mutation in the MYBPC3 gene. Adults with a MYBPC3 mutation, symptoms (NYHA Class II or III), and a certain level of preserved heart function may take part. The study is in Phase 1/Phase 2 and is currently enrolling participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase
PHASE1/PHASE2
Status
Recruiting
Sponsor
Tenaya Therapeutics
Intervention
TN-201
Start date
8/10/2023
Estimated completion
8/1/2032
Countries
United States

Related genes

Locations

  • La Jolla, United States
  • San Francisco, United States
  • Atlanta, United States
  • Boston, United States
  • Rochester, United States
  • Cincinnati, United States
  • Cleveland, United States
  • Portland, United States
  • Philadelphia, United States
  • Houston, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* MYBPC3 mutation
* Hypertrophic Cardiomyopathy (obstructive and nonobstructive)
* Left Ventricular Ejection Fraction ≥45%
* NYHA Functional Class II or III symptoms
* NT-proBNP ≥160pg/ml

Exclusion Criteria:

* High AAV9 neutralizing antibody titer
This is not medical advice. Consult your specialist.
View the official record on ClinicalTrials.gov →