Safety and Efficacy of FAP iCDC in Ischemic Cardiomyopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: autologus FAP-targeted immunosuppressive CAR-DCs (iCDC), Standard medical treatment.
- Who it may be relevant to
- Registry conditions: Ischemic Cardiomyopathy, Cell Therapy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Efficacy of FAP-Targeted Immunosuppressive CAR-DC in the Treatment of Ischemic Cardiomyopathy
Overview
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.
Detailed description
Ischemic heart disease (IHD) is becoming an increasingly serious global public health challenge due to its rising prevalence and the continuous increase in human life expectancy. Despite substantial advances in reperfusion therapy, pharmacological treatment, and risk factor management in recent decades, clinical prognosis remains poor. Many patients continue to experience adverse cardiac remodeling after the initial ischemic injury and eventually progress to heart failure. This persistent residual risk suggests that current therapeutic strategies do not fully address key pathogenic mechanisms underlying disease progression. Inflammation plays a central role in linking acute myocardial injury to chronic cardiac remodeling.
Dendritic cells (DCs), as professional antigen-presenting cells, function at the interface between innate and adaptive immunity and play a critical role in coordinating immune responses within the tissue microenvironment. Recent advances in the study of tolerogenic dendritic cells (tolerogenic DCs) have provided new insights into their potential application in cardiovascular diseases. Unlike conventional immunostimulatory DCs, tolerogenic DCs can induce antigen-specific immune tolerance through multiple mechanisms, including secretion of regulatory cytokines, expression of co-inhibitory ligands, suppression of effector T-cell responses, and induction of regulatory T cells. These properties make DCs a promising but underexplored platform for immune modulation.
This study evaluates a novel therapeutic strategy using fibroblast activation protein (FAP)-targeted autologous immunosuppressive chimeric antigen receptor dendritic cell (CAR-DC) therapy, also referred to as iCDC therapy, in patients with ischemic cardiomyopathy. This approach is designed to direct engineered dendritic cells to sites of cardiac injury and fibrosis, with the goal of modulating the balance between injurious and reparative immune responses. By targeting local immune regulation at the site of injury, this strategy may help attenuate adverse cardiac remodeling while potentially avoiding the systemic immunosuppression associated with conventional therapies.
Interventions
- Biological autologus FAP-targeted immunosuppressive CAR-DCs (iCDC)
Each subject receives FAP-targeted immunosuppressive CAR-DCs by intravenous infusion after enrollment. - Other 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.
Primary outcome measures
- Incidence of Dose-Limiting Toxicities (DLT) [Time frame: Within 14 days after treatment]
- Incidence of Treatment-Emergent Adverse Events (TEAE) [Time frame: Within 6 months after treatment]
Secondary outcome measures (12)
- Change in Left Ventricular Ejection Fraction (LVEF) by Echocardiography [Time frame: Baseline, 3 months, 6 months]
- Change in left ventricular end-systolic volume (LVESV) as assessed by Echocardiography [Time frame: Baseline, 3 months, and 6 months]
- Change in left ventricular end-diastolic volume (LVEDV) by Echocardiography [Time frame: Baseline, 3 months, and 6 months]
- Change in global longitudinal strain (GLS) measured by Echocardiography [Time frame: Baseline, 3 months, 6 months]
- Change in wall motion score index (WMSI) measured by Echocardiography [Time frame: Baseline, 3 months, 6 months]
- Change in left ventricular ejection fraction (LVEF) by Cardiac Magnetic Resonance Imaging [Time frame: Baseline, 6 months]
- Change in left ventricular end-systolic volume (LVESV) by Cardiac Magnetic Resonance Imaging [Time frame: Baseline and 6 months]
- Change in left ventricular end-diastolic volume (LVEDV) by Cardiac Magnetic Resonance Imaging [Time frame: Baseline, 6 months]
- Change in stroke volume (SV) by Cardiac Magnetic Resonance Imaging [Time frame: Baseline and 6 months]
- Change in Myocardial Late Gadolinium Enhancement Volume by Cardiac Magnetic Resonance Imaging [Time frame: Baseline and 6 months]
- Change in Extracellular Volume Fraction in Remote Myocardium by Cardiac Magnetic Resonance Imaging [Time frame: Baseline and 6 months]
- Change in Myocardial Scar Transmurality by Cardiac Magnetic Resonance Imaging [Time frame: Baseline and 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou
Identifiers
NCT: NCT07505199 · YAN2026-0257