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An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)

RecruitingPhase 1, Phase 2Ages 18 Years - 70 YearsAllAffinia Therapeutics
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In plain words

What the trial is, and whether it could suit you

This is a Phase 1/2, open-label, dose-exploration and dose-expansion, clinical trial evaluating the safety, tolerability, pharmacodynamics, and preliminary efficacy of a single intravenous infusion of AFTX-201 in adults with dilated cardiomyopathy caused by a BAG3 gene mutation

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Male or female, 18 to 70 years of age Truncating mutation in BAG3 Dilated cardiomyopathy with left ventricular ejection fraction (LVEF) \< 50% by echocardiogram or cardiac MRI NYHA Class II or III heart failure symptoms Body weight โ‰ค 120 kg Willing and able to sign informed consent and comply with study procedures Exclusion Criteria: Prior myocardial infarction when, in the investigator's judgment, the totality of clinical and imaging evidence supports that left ventricular dysfunction is due to coronary artery disease rather than BAG3-associated dilated cardiomyopathy Prior heart transplant Presence or requirement of a left ventricular assist device (LVAD) IV therapy with positive inotropes, vasodilators, or diuretics for heart failure within 30 days prior to enrollment Positive neutralizing antibodies to ATC-0187 Any condition that, in the investigator's opinion, would place the subject at undue risk or interfere with study participation or interpretation of results
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What it tests

  • AFTX-201
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Where

5 sites
University of Miami Hospital and Clinics
Miami, United States
St. Lukes Hospital
Kansas City, United States
NYU Langone
New York, United States
Houston Methodist Hospital
Houston, United States
Institut de Cardiologie de Montrรฉal / Montreal Heart Institute
Montreal, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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