Testing a modified immune cell treatment for end-stage enlarged heart muscle
Tests modified immune cells in adults with end-stage enlarged heart muscle.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of FAP iCDC in End-stage Dilated Cardiomyopathy
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06902896, who can take part
Where in China
- Second Affiliated Hospital, School of Medicine, Zhejiang UniversityHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT06902896
- Record updated
- 14 July 2026
- Original description
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.Read full original descriptionShow less
Safety and Efficacy of Immunosuppressive CAR-DC Targeting FAP in the Treatment of End-stage Dilated Cardiomyopathy
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.
Inclusion: Age between 18 years old and 75 years old, diagnosed with dilated cardiomyopathy; Able to verbally confirm that he/she understands the risks, benefits and treatment options of the iCDC trial. He/she or his/her legal representative provides written informed consent before participating in the clinical trial; 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 <35%, NYHA functional class ⅢB-IV, INTERMACS class 3-6; Blood test: hematocrit >30%, lymphocytes >0.5×10\^9/L, platelets >60×10\^9/L.
Exclusion: History of myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks before enrollment; CRT implanted within 12 weeks before enrollment or intended to implant CRT device; Previous heart transplantation or implantation of a ventricular assist device or similar device, or planned implantation of a ventricular assist device or similar device; History of concurrent severe infection, hepatobiliary obstruction, or malignancy; Contraindications to study drugs or tests; 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; Symptomatic bradycardia or second/third degree heart block; Active autoimmune disease requiring immunosuppressive therapy; A history of tuberculosis; 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; History of severe renal failure or need for dialysis, creatinine >2.5 mg/dl; Uncorrected thrombocytopenia or systemic coagulopathy (platelet count < 50,000, INR > 2.5, or aPTT > 2.5 times control in the absence of anticoagulation), or active bleeding and uncorrectable coagulopathy; Aspartate aminotransferase or alanine aminotransferase levels greater than 5.0 times the upper limit of normal (ULN), total bilirubin >3 mg/dl; Pulmonary Embolism (PE); Severe hemodynamic instability (eg, shock); Women who are pregnant or may become pregnant.