[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625729":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":27,"responsibleParty":62,"collaborators":19,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":19,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":30,"whyStopped":19,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Affinia Therapeutics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AFTX-201","EXPERIMENTAL","Participants will receive a single intravenous dose of AFTX-201",[13],"Genetic: AFTX-201",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"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",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Clinical Trials Information","CONTACT","(617) 430-7817","2","clinicaltrials@affiniatx.com",[28,47],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"University of Miami Hospital and Clinics","RECRUITING","Miami","Florida","33136","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-80.19366,25.77427,{"lat":40,"lon":39},[43],{"name":44,"role":23,"phone":45,"phoneExt":19,"email":46},"Lina Carceres","954 249 3587","caceresl@miami.edu",{"facility":48,"status":30,"city":49,"state":50,"zip":51,"country":34,"countryCode":35,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Houston Methodist Hospital","Houston","Texas","77030",{"type":37,"coordinates":53},[54,55],-95.36327,29.76328,{"lat":55,"lon":54},[58],{"name":59,"role":23,"phone":60,"phoneExt":19,"email":61},"Jennifer (Garrett) Medley Sr. Clinical Trials Manager","346-238-4516","jmgarrett@houstonmethodist.org",{"type":63,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100625729","phase-1-an-aav-gene-therapy-trial-of-aftx-201-in-adults-with-bag3-associated-dilated-cardiomyopathy-dcm-100625729",false,"NCT07426419","An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)","A Phase 1\u002F2 Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Trial to Assess the Safety, Tolerability, Pharmacodynamics, and Preliminary Efficacy of AFTX-201 Administered to Adult Participants With BCL2-Associated Athanogene 3 (BAG3) Mutation-Associated Dilated Cardiomyopathy: UPBEAT Trial","UPBEAT","Inclusion Criteria:\n\nMale or female, 18 to 55 years of age\n\nTruncating mutation in BAG3\n\nDilated cardiomyopathy with left ventricular ejection fraction (LVEF) \\\u003C 45%\n\nNYHA Class II or III heart failure symptoms\n\nNT-proBNP ≥ 300 pg\u002FmL for subjects in sinus rhythm or paced rhythm, or ≥ 600 pg\u002FmL for subjects in atrial fibrillation\n\nWilling and able to sign informed consent and comply with study procedures\n\nExclusion Criteria:\n\nPrior myocardial infarction, heart transplant, or presence\u002Frequirement of a left ventricular assist device (LVAD)\n\nIV therapy with positive inotropes, vasodilators, or diuretics for heart failure within 30 days prior to enrollment\n\nPositive neutralizing antibodies to ATC-0187\n\nAny condition that, in the investigator's opinion, would place the subject at undue risk or interfere with study participation or interpretation of results","ALL","18 Years","55 Years",{"count":76,"type":77},22,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE1","PHASE2","This is a Phase 1\u002F2, 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",[84,85],"Dilated Cardiomyopathy (DCM)","BAG3 Mutation Associated Dilated Cardiomyopathy",[9,87,88,89,90,91,92],"Gene Therapy","AAV","BAG3","Dilated Cardiomyopathy","DCM","ATC-0187","2026-06-30",{"date":95,"type":96},"2026-07-02","ACTUAL",{"date":98,"type":77},"2026-06",{"date":100,"type":77},"2032-12",{"name":5,"class":6},2]