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

Study acronym: UPBEAT
StatusRecruiting
PhasePhase 1/2
Started

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Record History

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  1. Start date pushed from Sep 2026 to Oct 2026
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: 6 to 8
    • Site details revised at 1 of 4 sites
  2. Study sites: 3 to 4v9
  3. Start date: Jun 2026 to Sep 2026
    • Eligibility criteria revised
    v8
  4. Study sites: 2 to 3v7
  5. Recruitment opened
    • Study sites: 1 to 2
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v5
  2. Site contact updatedv4
  3. Re-verified, no change to tracked fieldsv3
  4. Start date: Mar 2026 to Jun 2026
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT07426419
Lead Sponsor Affinia Therapeutics
Conditions
(from sponsor)		 Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
Related terms Cardiomyopathy, Dilated
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov