An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
Recruiting
Phase 1
Phase 2
Interventional Study
Dilated Cardiomyopathy (DCM)
BAG3 Mutation Associated Dilated Cardiomyopathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 55
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 22 (estimated)
- Sponsor
- Affinia Therapeutics · Industry
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About This Trial
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
Trial Locations
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Eligibility Criteria
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 s…
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