[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625729":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":27,"responsibleParty":61,"collaborators":19,"id":63,"slug":19,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":19,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":30,"whyStopped":19,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"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",[28,46],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"University of Miami Hospital and Clinics","RECRUITING","Miami","Florida","33136","United States",{"type":36,"coordinates":37},"Point",[38,39],-80.19366,25.77427,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":44,"phoneExt":19,"email":45},"Lina Carceres","954 249 3587","caceresl@miami.edu",{"facility":47,"status":30,"city":48,"state":49,"zip":50,"country":34,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Houston Methodist Hospital","Houston","Texas","77030",{"type":36,"coordinates":52},[53,54],-95.36327,29.76328,{"lat":54,"lon":53},[57],{"name":58,"role":23,"phone":59,"phoneExt":19,"email":60},"Jennifer (Garrett) Medley Sr. Clinical Trials Manager","346-238-4516","jmgarrett@houstonmethodist.org",{"type":62,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","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":74,"type":75},22,"ESTIMATED","INTERVENTIONAL",[78,79],"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",[82,83],"Dilated Cardiomyopathy (DCM)","BAG3 Mutation Associated Dilated Cardiomyopathy",[9,85,86,87,88,89,90],"Gene Therapy","AAV","BAG3","Dilated Cardiomyopathy","DCM","ATC-0187","2026-06-30",{"date":93,"type":94},"2026-07-02","ACTUAL",{"date":96,"type":75},"2026-06",{"date":98,"type":75},"2032-12",{"name":5,"class":6},2]