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NCT07426419PHASE1, PHASE2Recruiting

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

Affinia Therapeutics

Start Date

6/1/2026

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 55 years

Inclusion Criteria: Male or female, 18 to 55 years of age Truncating mutation in BAG3 Dilated cardiomyopathy with left ventricular ejection fraction (LVEF) \< 45% NYHA Class II or III heart failure symptoms NT-proBNP ≥ 300 pg/mL for subjects in sinus rhythm or paced rhythm, or ≥ 600 pg/mL for subjects in atrial fibrillation Willing and able to sign informed consent and comply with study procedures Exclusion Criteria: Prior myocardial infarction, heart transplant, or presence/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

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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