Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Phase 1
Started
2026-05-21
Last updated
2026-07-02
Condition(s) studied
Ischemic CardiomyopathyCell Therapy
Investigational drug(s) / intervention(s)
autologus FAP-targeted immunosuppressive CAR-DCs (iCDC)Standard medical treatment
autologus FAP-targeted immunosuppressive CAR-DCs (iCDC): Each subject receives FAP-targeted immunosuppressive CAR-DCs by intravenous infusion after enrollment.
Standard medical treatment: 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of Dose-Limiting Toxicities (DLT) — Within 14 days after treatment Incidence of dose-limiting toxicities (DLT) within 14 days after administration of FAP-targeted immunoregulatory CAR-DC therapy
Incidence of Treatment-Emergent Adverse Events (TEAE) — Within 6 months after treatment Incidence of treatment-emergent adverse events (TEAE) occurring within 6 months after treatment in patients with ischemic cardiomyopathy.
Trial sites (1)
Facility
City
Region
Status
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
Zhejiang / 浙江
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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