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

RecruitingPhase 1, Phase 2

Sponsor: Affinia Therapeutics

Conditions: Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy

Interventions: AFTX-201

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

Male or female, 18 to 70 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

Locations (3)

Miami, Florida, United States
Kansas City, Missouri, United States
Houston, Texas, United States