Phase 1/2Recruiting
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM) (UPBEAT)
A Phase 1/2 Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Trial to Assess the Safety, Tolerability, Pharmacodynamics, and Preliminary Efficacy of AFTX-201 Administered to Adult Participants With BCL2-Associated Athanogene 3 (BAG3) Mutation-Associated Dilated Cardiomyopathy: UPBEAT Trial
- Sponsor
- Affinia Therapeutics (Industry)
- Enrollment
- 22 planned
- Conditions
- Dilated Cardiomyopathy (DCM); BAG3 Mutation Associated Dilated Cardiomyopathy
- Interventions
- AFTX-201
- Ages
- adults, older adults
- Registry
- NCT07426419
Full record on ClinicalTrials.gov
From the registry
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
Primary outcomes
- Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
History
Study completion expected
Primary completion expected
Expected to start
Last registry update
Registered