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RecruitingPhase 1/Phase 2

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

Affinia Therapeutics · NCT07426419

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
22
US sites recruiting
4
Study start
October 2026
Record last updated
October 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: AFTX-201

Conditions: Dilated Cardiomyopathy (DCM); BAG3 Mutation Associated Dilated Cardiomyopathy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

Male or female, 18 to 70 years of age

Truncating mutation in BAG3

Dilated cardiomyopathy with left ventricular ejection fraction (LVEF) \< 50% by echocardiogram or cardiac MRI

NYHA Class II or III heart failure symptoms

Body weight ≤ 120 kg

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

Exclusion Criteria

Prior myocardial infarction when, in the investigator's judgment, the totality of clinical and imaging evidence supports that left ventricular dysfunction is due to coronary artery disease rather than BAG3-associated dilated cardiomyopathy

Prior heart transplant

Presence or 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

Recruiting US locations

  • University of Miami Hospital and Clinics

    Miami, FL 33136

    Site contact: Lina Carceres · 954 249 3587 · caceresl@miami.edu

  • St. Lukes Hospital

    Kansas City, MO 64111

    Site contact: Amanda Huffman, RN, BSN · 816-932-0391 · amanda.huffman@bjc.org

  • NYU Langone

    New York, NY 10016

    Site contact: Loriya Thao · 646-877-6343 · loriya.thao@nyulangone.org

  • Houston Methodist Hospital

    Houston, TX 77030

    Site contact: Jennifer (Garrett) Medley Sr. Clinical Trials Manager · 346-238-4516 · jmgarrett@houstonmethodist.org

Study contacts (from the official record)

  • Clinical Trials Information · (617) 430-7817 · clinicaltrials@affiniatx.com
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An AAV Gene Therapy Trial of AFTX-201 in Adults With… (NCT07426419) | Bored Studies