Recruiting
Phase 1
Phase 2

AFTX-201

Sponsor:

Affinia Therapeutics

Code:

NCT07426419

Conditions

Dilated Cardiomyopathy (DCM)

BAG3 Mutation Associated Dilated Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

AFTX-201

Study Details

Brief 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

Conditions

Dilated Cardiomyopathy (DCM)

BAG3 Mutation Associated Dilated Cardiomyopathy

Study ID

NCT07426419

Start date

Sep, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2032

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

Male or female, 18 to 70 years of age

Truncating mutation in BAG3

Dilated cardiomyopathy with left ventricular ejection fraction (LVEF) < 45%

NYHA Class II or III heart failure symptoms

NT-proBNP ≥ 300 pg/mL for subjects in sinus rhythm or paced rhythm, or ≥ 600 pg/mL for subjects in atrial fibrillation

Willing and able to sign informed consent and comply with study procedures

Exclusion Criteria:

Prior myocardial infarction, heart transplant, or presence/requirement of a left ventricular assist device (LVAD)

IV therapy with positive inotropes, vasodilators, or diuretics for heart failure within 30 days prior to enrollment

Positive neutralizing antibodies to ATC-0187

Any condition that, in the investigator's opinion, would place the subject at undue risk or interfere with study participation or interpretation of results

Study Design

Enrollment

22 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AFTX-201

Participants will receive a single intravenous dose of AFTX-201

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

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 and Locations

Central contacts

Clinical Trials Information

(617) 430-7817clinicaltrials@affiniatx.com

Locations

University of Miami Hospital and Clinics

Recruiting

Miami, Florida, United States, 33136

Contacts

Lina Carceres

954 249 3587caceresl@miami.edu

St. Lukes Hospital

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Amanda Huffman, RN, BSN

816-932-0391amanda.huffman@bjc.org

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Jennifer (Garrett) Medley Sr. Clinical Trials Manager

346-238-4516jmgarrett@houstonmethodist.org

Institut de Cardiologie de Montréal / Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, QC H1T 1C8

Contacts

Jérémie Coordonnateur de recherche EPS / EP research coordinator, BScN

514-376-3330Jeremie.Cortial@icm-mhi.org

Principal Investigator:

Rafik Tadros, MD

More Information

Sponsor

Affinia Therapeutics

Last update posted

Sep 1, 2026

Last verified

Jul, 2026

Keywords

  • AFTX-201
  • Gene Therapy
  • AAV
  • BAG3
  • Dilated Cardiomyopathy
  • DCM
  • ATC-0187

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Affinia Therapeutics on 2026-09-01.