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

Recruiting now · Phase 1/Phase 2

Conditions studied: Dilated Cardiomyopathy (DCM), Heart Failure

In brief

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.

Key facts

Study ID

NCT06902896

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

43

Starts

2025-04-22

Expected to finish

2028-12-31

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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