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Recruiting Phase 1/2

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

NCT07426419 · tracked via the Priya Life Science USA tracker
Sponsor
Affinia Therapeutics
Phase
Phase 1/2
Started
2026-12
Last updated
2026-11-03

Condition(s) studied

Dilated Cardiomyopathy (DCM)BAG3 Mutation Associated Dilated Cardiomyopathy

Investigational drug(s) / intervention(s)

AFTX-201

AFTX-201: AFTX-201 is a gene therapy product consisting of the ATC-0187 capsid containing the BCL2-associated Athanogene 3 (BAG3) transgene. It is administered as a single intravenous infusion

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) — Baseline through 12 months
    Safety and tolerability of AFTX-201 over 12 months.

Trial sites (5)

FacilityCityRegionStatus
University of Miami Hospital and Clinics Miami Florida Recruiting
St. Lukes Hospital Kansas City Missouri Recruiting
NYU Langone New York New York Recruiting
Houston Methodist Hospital Houston Texas Recruiting
Institut de Cardiologie de Montréal / Montreal Heart Institute Montreal Quebec Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07426419 on ClinicalTrials.gov ↗ ← All trials in the USA