Safety and Efficacy of FAP iCDC in Ischemic Cardiomyopathy
Safety and Efficacy of FAP-Targeted Immunosuppressive CAR-DC in the Treatment of Ischemic Cardiomyopathy
Second Affiliated Hospital, School of Medicine, Zhejiang University
30 participants
May 21, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria11
- 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.
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Interventions
Each subject receives FAP-targeted immunosuppressive CAR-DCs by intravenous infusion after enrollment.
Participants receive standard medical treatment for ischemic cardiomyopathy according to current clinical practice and guideline-directed medical therapy. No iCDC therapy is administered in this arm.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07505199