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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

Join a study on TN-201 for heart condition safety evaluation.

Recruiting
18-75 years
All
Phase 1/2
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is a first-of-its-kind research looking at the safety and effects of a new medicine called TN-201 for people with a heart condition called hypertrophic cardiomyopathy (HCM). HCM is when the heart muscle is thicker than normal. The study is for adults whose HCM is caused by a change in the MYBPC3 gene. All participants will receive a single dose of TN-201 gene therapy and will be followed for 5 years to check how safe and tolerable it is. To join, you must have certain symptoms of HCM, and your heart's ability to pump blood, called the ejection fraction, should be at least 45%. You should also have a specific level of a protein called NT-proBNP in your blood. If your body has high levels of antibodies that could attack the TN-201, you cannot participate.

  • The study lasts for 5 years with several follow-up visits.
  • All participants get the TN-201 treatment.
  • There are no placebos; everyone gets the actual treatment.
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Study details
    Hypertrophic Cardiomyopathy

NCT05836259

Tenaya Therapeutics

30 November 2024

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