Safety and better outcomes with FAP-targeted immunosuppressive dendritic cells in ischemic heart failure

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 first-in-human study examines the safety and potential effectiveness of autologous FAP-targeted immunosuppressive CAR-DCs (iCDC) added to standard medical therapy in adults with ischemic cardiomyopathy and reduced heart function. Participants receive their own engineered dendritic cells designed to promote immune tolerance and reduce damaging inflammation, along with routine heart failure management. The study will monitor safety signals and look for preliminary signs of benefit on heart function and remodeling. It is conducted at a single center in Hangzhou, China, under an early-phase framework to establish feasibility and tolerability. Mechanistically, the approach targets inflammatory pathways thought to connect acute injury to chronic heart failure progression.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years and ≤75 years.
* Diagnosis of ischemic cardiomyopathy, with at least 3 months of optimized guideline-directed medical therapy (GDMT) at maximally tolerated doses; left ventricular ejection fraction (LVEF) \<35%; New York Heart Association (NYHA) functional class III-IV.
* Ability to understand the risks, benefits, and treatment alternatives of immunoregulatory CAR-DC therapy, and willingness to participate in the study; the patient or his/her legally authorized representative must provide written informed consent prior to study enrollment.
* Adequate hematologic function defined as: hematocrit \>30%, lymphocyte count \>0.5 × 10⁹/L, and platelet count \>60 × 10⁹/L.

Exclusion Criteria:

* Life expectancy \<1 year due to non-cardiac conditions.

Cardiac resynchronization therapy (CRT) implantation within 3 months prior to enrollment or planned CRT implantation.

Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to enrollment OR plan to PCI.

Presence of non-ischemic cardiomyopathy, including but not limited to dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic cardiomyopathy, peripartum cardiomyopathy, inflammatory or immune-mediated cardiomyopathy, metabolic or genetic cardiomyopathy, or cardiomyopathy secondary to moderate-to-severe valvular heart disease, congenital heart disease, or other non-ischemic etiologies.

Persistent hemodynamic instability.

End-stage renal disease (eGFR \<25 mL/min/1.73 m²) requiring or receiving renal replacement therapy (hemodialysis or peritoneal dialysis).

Active autoimmune disease requiring immunosuppressive therapy.

History of malignancy.

Active infection, including but not limited to active hepatitis B (HBV DNA \>1000 copies/mL by PCR), hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection, or uncontrolled systemic fungal, bacterial, viral, or other infections.

Pregnant women.

Known contraindications to the investigational product or study-related procedures.

Where it's running

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

Study contacts

• Study coordinator: Jiamin Li, MD
• Email: 21818216@zju.edu.cn
• Phone: 86-18868112006

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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.