RecruitingPhase 1Phase 2NCT07426419

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

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

Enrollment

22 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying AFTX-201 for people with bag3 mutation associated dilated cardiomyopathy and dilated cardiomyopathy (dcm). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICAFTX-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(3)

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

View Full Details on ClinicalTrials.gov

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NCT07426419


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