FAP-targeted immunosuppressive CAR-DC therapy for end-stage dilated cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-phase, single-center, open-label study evaluating the safety and preliminary efficacy of FAP-targeted immunosuppressive CAR-DC therapy in adults with end-stage dilated cardiomyopathy and heart failure. Phase 1 uses a 3+3 dose-escalation design to identify a safe and potentially effective dose. Phase 2 expands at that dose and includes a non-randomized concurrent control group receiving standard therapy. The intervention involves administering iCDC therapy, with safety, adverse events, and early efficacy assessments guiding progression. Eligible participants have reduced ejection fraction, advanced symptoms, and meet specific lab and functional criteria, while exclusions include recent major cardiac events or recent device implants.

Why it matters

Who can join: the full rules

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.

Where it's running

• Second Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Xinyang Hu, PhD — 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
• Study coordinator: Jiamin Li, MD
• Email: 21818216@zju.edu.cn
• Phone: 86-18868112006

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.