Skip to main content
Back to Trials
NCT07426419PHASE1, PHASE2Recruiting

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

Affinia Therapeutics

Start Date

10/1/2026

Completion Date

12/1/2032

Summary

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

Detailed Description

Participants will receive a single intravenous infusion of AFTX-201 and will be followed for safety and clinical assessments. The study includes short-term safety monitoring and long-term follow-up for up to 60 months

Eligibility Criteria

Age Range: 18 years to 70 years

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 ≤ 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

Interventions

GENETIC

AFTX-201

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Dilated Cardiomyopathy (DCM)BAG3 Mutation Associated Dilated Cardiomyopathy

Locations

University of Miami Hospital and Clinics

Miami, Florida 33136

United States

St. Lukes Hospital

Kansas City, Missouri 64111

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

Institut de Cardiologie de Montréal / Montreal Heart Institute

Montreal, Quebec QC H1T 1C8

Canada