An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
Recruiting now · Phase 1/Phase 2
Conditions studied: Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
In brief
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
Key facts
- Study ID
- NCT07426419
- Run by
- Affinia Therapeutics
- People needed
- 22
- Starts
- 2026-06-01
- Expected to finish
- 2032-12-01
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Miami Hospital and Clinics — Miami, Florida, United States (enrolling)
- St. Lukes Hospital — Kansas City, Missouri, United States (enrolling)
- Houston Methodist Hospital — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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