Safety and Efficacy of FAP iCDC in Ischemic Cardiomyopathy

Recruiting now · Phase 1

Conditions studied: Ischemic Cardiomyopathy, Cell Therapy

In brief

This study aims to evaluate the safety and efficacy of fibroblast activation protein (FAP)-targeted autologous immunosuppressive chimeric antigen receptor dendritic cell (iCDC) therapy in patients with ischemic cardiomyopathy, and to explore its potential as a novel therapeutic strategy for this disease.

Key facts

Study ID

NCT07505199

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

30

Starts

2026-05-21

Expected to finish

2029-04-01

Last updated by the study team

2026-07-02

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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