[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631785":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Administration of autologus FAP iCDC","EXPERIMENTAL","Administration of FAP immunosuppressive CAR-DC cell therapy in ischemic cardiomyopathy. Patients are planned to be enrolled in the dose-escalation trial (1×10\\^5\u002Fkg、4×10\\^5\u002Fkg、and 8×10\\^5\u002Fkg) .The first dose group (4×10⁵\u002Fkg) initially enrolls 3 subjects to observe Dose-Limiting Toxicity (DLT) responses. （1）If no DLT occurs and all 3 subjects demonstrate efficacy after 6 months of treatment, and this dose is determined as the safe and effective dose. （2）If 1 subject experiences DLT, 3 additional subjects are enrolled. ·If 1\u002F6 subjects develops DLT, and efficacy is not fully achieved in all 6 subjects, escalate to the next dose group (8×10\\^5\u002Fkg). ·If ≥2\u002F6 subjects develop DLT, de-escalate to the previous dose group (1×10\\^5\u002Fkg). （3）After identifying a safe and effective dose, enrollment will be expanded at this dose to bring the total sample size to 15 subjects, to further evaluate safety and efficacy.",[13],"Biological: autologus FAP-targeted immunosuppressive CAR-DCs (iCDC)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard treatment control","ACTIVE_COMPARATOR","Participants in this arm will receive standard medical treatment for ischemic cardiomyopathy according to current clinical practice and guideline-directed medical therapy. These participants will not receive iCDC therapy but will undergo scheduled follow-up assessments for safety and efficacy comparisons.",[19],"Other: Standard medical treatment",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","autologus FAP-targeted immunosuppressive CAR-DCs (iCDC)","Each subject receives FAP-targeted immunosuppressive CAR-DCs by intravenous infusion after enrollment.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard medical treatment","Participants receive standard medical treatment for ischemic cardiomyopathy according to current clinical practice and guideline-directed medical therapy. No iCDC therapy is administered in this arm.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Jiamin Li, MD","CONTACT","86-18868112006","21818216@zju.edu.cn",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Hangzhou","Zhejiang \u002F 浙江","310009","China","CN",{"type":46,"coordinates":47},"Point",[48,49],120.16142,30.29365,{"lat":49,"lon":48},[52,55],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":36},"Jiamin Li, Dr","18868112006",{"name":26,"role":34,"phone":26,"phoneExt":26,"email":36},{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100631785","phase-1-safety-and-efficacy-of-fap-icdc-in-ischemic-cardiomyopathy-100631785",false,"NCT07505199","Safety and Efficacy of FAP iCDC in Ischemic Cardiomyopathy","Safety and Efficacy of FAP-Targeted Immunosuppressive CAR-DC in the Treatment of Ischemic Cardiomyopathy","Inclusion Criteria:\n\n* Age ≥18 years and ≤75 years.\n* Diagnosis of ischemic cardiomyopathy, with at least 3 months of optimized guideline-directed medical therapy (GDMT) at maximally tolerated doses; left ventricular ejection fraction (LVEF) \\\u003C35%; New York Heart Association (NYHA) functional class III-IV.\n* Ability to understand the risks, benefits, and treatment alternatives of immunoregulatory CAR-DC therapy, and willingness to participate in the study; the patient or his\u002Fher legally authorized representative must provide written informed consent prior to study enrollment.\n* Adequate hematologic function defined as: hematocrit \\>30%, lymphocyte count \\>0.5 × 10⁹\u002FL, and platelet count \\>60 × 10⁹\u002FL.\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C1 year due to non-cardiac conditions.\n\nCardiac resynchronization therapy (CRT) implantation within 3 months prior to enrollment or planned CRT implantation.\n\nPercutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to enrollment OR plan to PCI.\n\nPresence of non-ischemic cardiomyopathy, including but not limited to dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic cardiomyopathy, peripartum cardiomyopathy, inflammatory or immune-mediated cardiomyopathy, metabolic or genetic cardiomyopathy, or cardiomyopathy secondary to moderate-to-severe valvular heart disease, congenital heart disease, or other non-ischemic etiologies.\n\nPersistent hemodynamic instability.\n\nEnd-stage renal disease (eGFR \\\u003C25 mL\u002Fmin\u002F1.73 m²) requiring or receiving renal replacement therapy (hemodialysis or peritoneal dialysis).\n\nActive autoimmune disease requiring immunosuppressive therapy.\n\nHistory of malignancy.\n\nActive infection, including but not limited to active hepatitis B (HBV DNA \\>1000 copies\u002FmL by PCR), hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection, or uncontrolled systemic fungal, bacterial, viral, or other infections.\n\nPregnant women.\n\nKnown contraindications to the investigational product or study-related procedures.","ALL","18 Years","75 Years",{"count":69,"type":70},30,"ESTIMATED","INTERVENTIONAL",[73],"PHASE1","This study aims to evaluate the safety and efficacy of fibroblast activation protein (FAP)-targeted autologous immunosuppressive chimeric antigen receptor dendritic cell (iCDC) therapy in patients with ischemic cardiomyopathy, and to explore its potential as a novel therapeutic strategy for this disease.",[76,77],"Ischemic Cardiomyopathy","Cell Therapy",[79,80,81],"ischemic cardiomyopathy","dendritic cell","immune tolerance","2026-07-01",{"date":84,"type":85},"2026-07-02","ACTUAL",{"date":87,"type":85},"2026-05-21",{"date":89,"type":70},"2029-04-01",{"name":5,"class":6},1]