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Clinical Trials in China / NCT06902896
Recruiting Phase 1/2

Safety and Efficacy of FAP iCDC in End-stage Dilated Cardiomyopathy

NCT06902896 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Phase 1/2
Started
2025-04-22
Last updated
2026-07-14

Condition(s) studied

Dilated Cardiomyopathy (DCM)Heart Failure

Investigational drug(s) / intervention(s)

FAP immunosuppressive CAR-DC

FAP immunosuppressive CAR-DC: Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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. * 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. * Pulmonary Embolism (PE). * A history of tuberculosis. * 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. * History of concurrent severe infection, hepatobiliary obstruction, or malignancy. * 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. * Severe hemodynamic instability (eg, shock). * Women who are pregnant or may become pregnant. * Contraindications to study drugs or tests.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Second Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06902896 on ClinicalTrials.gov ↗ ← All trials in China