A Phase 1/2 interventional study of AFTX-201 in Dilated Cardiomyopathy (DCM) and BAG3 Mutation Associated Dilated Cardiomyopathy, sponsored by Affinia Therapeutics. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Affinia Therapeutics · Phase 1/2, Interventional, and Treatment
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
Participants will receive a single intravenous infusion of AFTX-201 and will be followed for safety and clinical assessments. The study includes short-term safety monitoring and long-term follow-up for up to 60 months
255 studies on the registry are indexed under Cardiomyopathy, Dilated; 66 are open to participants now.
This study's planned enrollment of 22 is below the median of 43 across 145 interventional studies indexed under Cardiomyopathy, Dilated.
Browse Cardiomyopathy, Dilated studies →This is the only study on the registry with Affinia Therapeutics as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 13, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Male or female, 18 to 70 years of age
Truncating mutation in BAG3
Dilated cardiomyopathy with (LVEF) \< 50% by echocardiogram or cardiac MRI
Class II or III heart failure symptoms
Body weight ≤ 120 kg
Willing and able to sign 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single intravenous dose of AFTX-201
Genetic: 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
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Safety and tolerability of AFTX-201 over 12 months.
Time frame: Baseline through 12 months
Change from baseline in pharmacodynamic biomarkers
Assessment of the extent of AFTX-201 transduction and myocardial BAG3 protein expression after a single IV dose
Time frame: Baseline through 12 months
Change from baseline in measurement of cardiac function including left ventricular ejection fraction (LVEF)
Assessment of the impact of a single IV dose of AFTX-201 on measurement of cardiovascular function
Time frame: Baseline through 12 months
Change from baseline in measurement of cardiac function including peak oxygen consumption (pVO2) by cardiopulmonary exercise test (CPET)
Assessment of the impact of a single IV dose of AFTX-201 on measurement of cardiovascular function
Time frame: Baseline through 12 months
Change from baseline in New York Heart Association (NYHA) functional class
Assessment of the impact of a single IV dose of AFTX-201 on features of heart failure (HF) including functional classification by New York Heart Association (NYHA) class
Time frame: Baseline through 12 months
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Assessment of the impact of a single IV dose of AFTX-201 on quality of life
Time frame: Baseline through 12 months
Change from baseline in NT-proBNP levels through 12 months
Assessment of the change from baseline in NT-proBNP levels following a single intravenous dose of AFTX-201
Time frame: Baseline through 12 months
Change from baseline in NT-proBNP levels during long-term follow-up
Assessment of the change from baseline in NT-proBNP levels during long-term follow-up following a single intravenous dose of AFTX-201
Time frame: Baseline through 60 months
Number of participants with adverse events during long-term follow-up
Safety and tolerability of AFTX-201 over 60 months
Time frame: Baseline through 60 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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