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First-in-Human, Open-Label, Safety, Tolerability, Dose-Finding, Pharmacodynamic and Cardiac Transgene Expression Study of TN-201, a Recombinant Adeno-associated Virus Serotype 9 (AAV9) Containing Myosin Binding Protein C Transgene, in Adults With MYBPC3 Mutation-associated Hypertrophic Cardiomyopathy (HCM)

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Trial Profile

First-in-Human, Open-Label, Safety, Tolerability, Dose-Finding, Pharmacodynamic and Cardiac Transgene Expression Study of TN-201, a Recombinant Adeno-associated Virus Serotype 9 (AAV9) Containing Myosin Binding Protein C Transgene, in Adults With MYBPC3 Mutation-associated Hypertrophic Cardiomyopathy (HCM)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 21 Mar 2026

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At a glance

  • Drugs Zertomibgene cazparvovec (Primary)
  • Indications Hypertrophic cardiomyopathy
  • Focus Adverse reactions; First in man
  • Acronyms MyPeak-1
  • Sponsors Tenaya Therapeutics

Most Recent Events

  • 12 Mar 2026 Status changed from active, no longer recruiting to recruiting. In January, following implementation of modest protocol amendments in alignment with the U.S. Food and Drug Administration (FDA) input, Tenaya resumed enrollment in MyPEAK-1 to generate additional safety and efficacy data.
  • 09 Jan 2026 According to a Tenaya Therapeutics media release, To date, seven patients have been enrolled in the MyPEAK-1 trial. Following implementation of modest protocol amendments in alignment with U.S. Food and Drug Administration (FDA) input, Tenaya expects to resume enrollment in the 6E13 vg/kg dose expansion cohort to generate additional safety and efficacy data in 2026
  • 09 Jan 2026 According to a Tenaya Therapeutics media release, In the second half of 2026, one-year Cohort 2 data and two-year Cohort 1 data from MyPEAK-1 are anticipated.

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