[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632638":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":20,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"dilated cardiomyopathy","EXPERIMENTAL","All participants will receive a second infusion of CAR-DC at the predetermined safe and effective dose of 4×10⁵ cells\u002Fkg, administered intravenously.",[13],"Biological: FAP immunosuppressive CAR-DC",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","FAP immunosuppressive CAR-DC","Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Xinyang Hu, PhD","Second Affiliated Hospital, School of Medicine, Zhejiang University, China","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Jiamin Li, MD","CONTACT","86-18868112006","21818216@zju.edu.cn",[33],{"facility":5,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Hangzhou","Zhejiang \u002F 浙江","310009","China","CN",{"type":41,"coordinates":42},"Point",[43,44],120.16142,30.29365,{"lat":44,"lon":43},[47,50],{"name":48,"role":29,"phone":49,"phoneExt":20,"email":31},"Jiamin Li, Dr","18868112006",{"name":20,"role":29,"phone":20,"phoneExt":20,"email":31},{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100632638","phase-1-safety-and-efficacy-of-second-infusion-of-fap-icdc-in-end-stage-dilated-cardiomyopathy-100632638",false,"NCT07516288","Safety and Efficacy of Second Infusion of FAP iCDC in End-stage Dilated Cardiomyopathy","Safety and Efficacy of Second Infusion of Autologous Immunosuppressive CAR-DC Targeting FAP in the Treatment of End-stage Dilated Cardiomyopathy","Inclusion Criteria:\n\n* ≥18 years and ≤75 years of age, with a confirmed diagnosis of dilated cardiomyopathy.\n* Patients who previously received a single infusion of immunosuppressive CAR-DC (iCDC) therapy and, at 6 months after the first treatment, failed to maintain improvement in cardiac function, with cardiac function declining to baseline levels prior to treatment. These patients should have persistent heart failure symptoms that cannot be adequately improved, with left ventricular ejection fraction (LVEF) \\\u003C35%, New York Heart Association (NYHA) functional class III-IV, and INTERMACS profile 3-6.\n* Able to verbally confirm understanding of the risks, benefits, and alternative treatment options of the second administration of iCDC therapy, and willing to participate in the study. The participant or his\u002Fher legal representative must provide written informed consent prior to enrollment.\n* Hematocrit \\>30%, lymphocyte count \\>0.5 × 10⁹\u002FL, and platelet count \\>60 × 10⁹\u002FL.\n\nExclusion Criteria:\n\n* Severe renal failure or requirement for renal dialysis, or serum creatinine \\>2.5 mg\u002FdL.\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 5.0 times the upper limit of normal (ULN), or total bilirubin \\>3 mg\u002FdL.\n* Presence of active infections at screening, including: Active hepatitis B infection with hepatitis B virus DNA \\>1000 copies\u002FmL by PCR testing; Hepatitis C virus infection; Syphilis; Human immunodeficiency virus (HIV) infection; Uncontrolled systemic fungal, bacterial, viral, or other pathogenic infections.\n* Severe hemodynamic instability (e.g., shock).\n* Known contraindications to the investigational product or study-related procedures.","ALL","18 Years","75 Years",{"count":64,"type":65},5,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","This study aims to evaluate the safety and preliminary efficacy of a second administration of fibroblast activation protein (FAP)-targeted immunosuppressive chimeric antigen receptor dendritic cells (CAR-DC) in patients with end-stage dilated cardiomyopathy.\n\nPrevious clinical research has shown that single-dose CAR-DC therapy is safe and may provide clinical benefit. However, some patients experience recurrent worsening of heart function after initial treatment. This study will assess whether a second CAR-DC infusion is safe and whether it can further improve cardiac function in this patient population.",[71,72],"Dilated Cardiomyopathy (DCM)","Heart Failure",[74,17],"end-stage dilated cardiomyopathy","2026-07-01",{"date":77,"type":78},"2026-07-02","ACTUAL",{"date":80,"type":78},"2026-05-11",{"date":82,"type":65},"2027-12-31",{"name":5,"class":6},1]