[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585479":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":55,"collaborators":18,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":18,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"iCDC Therapy","EXPERIMENTAL","Participants in this arm will receive FAP-targeted immunosuppressive chimeric antigen receptor-dendritic cell (iCDC) therapy.\n\nIn Phase 1, iCDC will be administered at predefined dose levels (1×10⁵, 4×10⁵, and 8×10⁵ cells\u002Fkg) using a modified single-arm 3+3 dose-escalation design. Safety and preliminary efficacy will be evaluated at each dose level. If a given dose level is deemed safe and effective at 1 month post-treatment, it will be selected as the safe and effective dose, and no further dose escalation will be pursued. Otherwise, dose escalation may proceed to the next predefined level in accordance with the protocol.\n\nIn Phase 2, additional participants will receive iCDC therapy at the safe and effective dose identified in Phase 1.",[13],"Biological: FAP immunosuppressive CAR-DC",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Participants in this arm will be enrolled in Phase 2 as a non-randomized concurrent control group. They must meet the eligibility criteria and, after providing informed consent, elect not to receive iCDC therapy but agree to study follow-up. These participants will not undergo leukapheresis, iCDC manufacturing, or cell infusion, and will continue to receive guideline-directed standard medical therapy. They will be followed using clinically feasible shared assessments for exploratory comparison with the iCDC therapy arm.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BIOLOGICAL","FAP immunosuppressive CAR-DC","Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion",[9],[26],{"name":27,"affiliation":28,"role":29},"Xinyang Hu, PhD","2nd Affiliated Hospital, School of Medicine, Zhejiang University, China","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Jiamin Li, MD","CONTACT","86-18868112006","21818216@zju.edu.cn",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Hangzhou","Zhejiang","310009","China","CN",{"type":45,"coordinates":46},"Point",[47,48],120.16142,30.29365,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":18,"email":54},"Xinyang Hu","86-0571-87783777","hxy0507@zju.edu.cn",{"type":56,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100585479","phase-1-safety-and-efficacy-of-fap-icdc-in-end-stage-dilated-cardiomyopathy-100585479",false,"NCT06902896","Safety and Efficacy of FAP iCDC in End-stage Dilated Cardiomyopathy","Safety and Efficacy of Immunosuppressive CAR-DC Targeting FAP in the Treatment of End-stage Dilated Cardiomyopathy","Inclusion Criteria:\n\n* Age between 18 years old and 75 years old, diagnosed with dilated cardiomyopathy.\n* Able to verbally confirm that he\u002Fshe understands the risks, benefits and treatment options of the iCDC trial. He\u002Fshe or his\u002Fher legal representative provides written informed consent before participating in the clinical trial.\n* Diagnosed with Heart Failure with reduced ejection fraction (HFrEF), optimized drug therapy (under maximum tolerance of GDMT) for at least 3 months, left ventricular ejection fraction \\\u003C35%, NYHA functional class ⅢB-IV, INTERMACS class 3-6.\n* Blood test: hematocrit \\>30%, lymphocytes \\>0.5×10\\^9\u002FL, platelets \\>60×10\\^9\u002FL.\n\nExclusion Criteria:\n\n* History of myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks before enrollment.\n* CRT implanted within 12 weeks before enrollment or intended to implant CRT device.\n* Previous heart transplantation or implantation of a ventricular assist device or similar device, or planned implantation of a ventricular assist device or similar device.\n* Heart failure caused by ischemic cardiomyopathy, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, long-standing hypertension, congenital structural heart disease, or uncorrected primary valvular disease.\n* Symptomatic bradycardia or second\u002Fthird degree heart block.\n* Active autoimmune disease requiring immunosuppressive therapy.\n* Pulmonary Embolism (PE).\n* A history of tuberculosis.\n* History of severe renal failure or need for dialysis, creatinine \\>2.5 mg\u002Fdl.\n* Uncorrected thrombocytopenia or systemic coagulopathy (platelet count \\\u003C 50,000, INR \\> 2.5, or aPTT \\> 2.5 times control in the absence of anticoagulation), or active bleeding and uncorrectable coagulopathy.\n* Aspartate aminotransferase or alanine aminotransferase levels greater than 5.0 times the upper limit of normal (ULN), total bilirubin \\>3 mg\u002Fdl.\n* History of concurrent severe infection, hepatobiliary obstruction, or malignancy.\n* Infections: Active hepatitis B (PCR-detected hepatitis B virus DNA copies \\> 1000), hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection at screening; uncontrolled systemic fungal, bacterial, viral, or other pathogen infection.\n* Severe hemodynamic instability (eg, shock).\n* Women who are pregnant or may become pregnant.\n* Contraindications to study drugs or tests.","ALL","18 Years","75 Years",{"count":68,"type":69},43,"ESTIMATED","INTERVENTIONAL",[72,73],"PHASE1","PHASE2","To study the safety and efficacy of fibroblast activation protein (FAP)-targeted immunosuppressive chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of end-stage dilated cardiomyopathy and provide a new method for the treatment of end-stage dilated cardiomyopathy.",[76,77],"Dilated Cardiomyopathy (DCM)","Heart Failure",[79,22],"end-stage dilated cardiomyopathy","2026-07-12",{"date":82,"type":83},"2026-07-14","ACTUAL",{"date":85,"type":83},"2025-04-22",{"date":87,"type":69},"2028-12-31",{"name":5,"class":6},1]