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

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

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.

Conditions3

Interventions1

Related trials

• Safety and Efficacy of Second Infusion of FAP iCDC in End-stage Dilated Cardiomyopathy — Second Affiliated Hospital, School of Medicine, Zhejiang University

Browse More Trials