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

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with end-stage dilated cardiomyopathy (DCM), a serious heart condition that can lead to heart failure. The study will test a type of therapy called FAP-targeted immunosuppressive chimeric antigen receptor-dendritic cell (iCDC) to see if it can safely help improve heart function in these patients. The trial is currently not recruiting participants, but it aims to help find better treatment options for those struggling with this condition.

To participate in the trial, individuals must be between 18 and 75 years old and have a diagnosis of dilated cardiomyopathy along with heart failure that is not well controlled despite current medications. Participants will need to give their written consent and confirm they understand the study's risks and benefits. It's important to note that individuals with certain medical conditions, such as a recent heart attack, specific heart devices, or severe infections, may not be eligible to join. If you or a loved one are considering participating in this trial, please discuss it with a healthcare provider to understand if it’s a suitable option.

Gender

ALL

Eligibility criteria

• 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), Deep Vein Thrombosis(DVT), or recurrent embolism.
• • 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.
• • Systolic blood pressure \<90 mmHg.
• • 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.