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An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
Sponsor: Affinia Therapeutics
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2026-09
Completion Date
2032-12
Last Updated
2026-09-01
Healthy Volunteers
No
Interventions
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
Locations (4)
University of Miami Hospital and Clinics
Miami, Florida, United States
St. Lukes Hospital
Kansas City, Missouri, United States
Houston Methodist Hospital
Houston, Texas, United States
Institut de Cardiologie de Montréal / Montreal Heart Institute
Montreal, Quebec, Canada