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

Part of paid clinical trials in Miami, Florida.

Sponsor
Affinia Therapeutics
Study ID
NCT07426419
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • BAG3 Mutation Associated Dilated Cardiomyopathy
  • Dilated Cardiomyopathy (DCM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • AFTX-201 — GENETIC
    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

Study Details

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

Key Dates

First listed
Feb 23, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2032

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AFTX-201
    Participants will receive a single intravenous dose of AFTX-201

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: Baseline through 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Miami Hospital and ClinicsMiamiFlorida33136
Lina Carceres
[email protected]
954 249 3587
St. Lukes HospitalKansas CityMissouri64111
Amanda Huffman, RN, BSN
[email protected]
816-932-0391
Houston Methodist HospitalHoustonTexas77030
Jennifer (Garrett) Medley Sr. Clinical Trials Manager
[email protected]
346-238-4516

Find similar trials in Miami, FL

By research site
University of Miami Hospital and Clinics· Miami, FLSt. Lukes Hospital· Kansas City, MOHouston Methodist Hospital· Houston, TX

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