A Phase 1 interventional study of autologus FAP-targeted immunosuppressive CAR-DCs (iCDC) and Standard medical treatment in Ischemic Cardiomyopathy and Cell Therapy, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 1, Interventional, and Treatment
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.
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.
Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Administration of FAP immunosuppressive CAR-DC cell therapy in ischemic cardiomyopathy. Patients are planned to be enrolled in the dose-escalation trial (1×10\^5/kg、4×10\^5/kg、and 8×10\^5/kg) .The first dose group (4×10⁵/kg) initially enrolls 3 subjects to observe Dose-Limiting Toxicity (DLT) responses. （1）If no DLT occurs and all 3 subjects demonstrate efficacy after 6 months of treatment, and this dose is determined as the safe and effective dose. （2）If 1 subject experiences DLT, 3 additional subjects are enrolled. ·If 1/6 subjects develops DLT, and efficacy is not fully achieved in all 6 subjects, escalate to the next dose group (8×10\^5/kg). ·If ≥2/6 subjects develop DLT, de-escalate to the previous dose group (1×10\^5/kg). （3）After identifying a safe and effective dose, enrollment will be expanded at this dose to bring the total sample size to 15 subjects, to further evaluate safety and efficacy.
Biological: autologus FAP-targeted immunosuppressive CAR-DCs (iCDC)
Participants in this arm will receive standard medical treatment for ischemic cardiomyopathy according to current clinical practice and guideline-directed medical therapy. These participants will not receive iCDC therapy but will undergo scheduled follow-up assessments for safety and efficacy comparisons.
Other: Standard medical treatment
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.
Incidence of Dose-Limiting Toxicities (DLT)
Incidence of dose-limiting toxicities (DLT) within 14 days after administration of FAP-targeted immunoregulatory CAR-DC therapy
Time frame: Within 14 days after treatment
Incidence of Treatment-Emergent Adverse Events (TEAE)
Incidence of treatment-emergent adverse events (TEAE) occurring within 6 months after treatment in patients with ischemic cardiomyopathy.
Time frame: Within 6 months after treatment
Change in Left Ventricular Ejection Fraction (LVEF) by Echocardiography
Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline, 3 months, 6 months
Change in left ventricular end-systolic volume (LVESV) as assessed by Echocardiography
Change from baseline in left ventricular end-systolic volume (LVESV)measured by echocardiography, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline, 3 months, and 6 months
Change in left ventricular end-diastolic volume (LVEDV) by Echocardiography
Change from baseline in left ventricular end-diastolic volume (LVEDV) measured by echocardiography, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline, 3 months, and 6 months
Change in global longitudinal strain (GLS) measured by Echocardiography
Change from baseline in global longitudinal strain (GLS) measured by echocardiography, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline, 3 months, 6 months
Change in wall motion score index (WMSI) measured by Echocardiography
Change from baseline in wall motion score index (WMSI) measured by echocardiography, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline, 3 months, 6 months
Change in left ventricular ejection fraction (LVEF) by Cardiac Magnetic Resonance Imaging
Change from baseline in left ventricular ejection fraction (LVEF) measured by cardiac magnetic resonance imaging, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline, 6 months
Change in left ventricular end-systolic volume (LVESV) by Cardiac Magnetic Resonance Imaging
Change from baseline in left ventricular end-systolic volume (LVESV) measured by cardiac magnetic resonance imaging, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline and 6 months
Change in left ventricular end-diastolic volume (LVEDV) by Cardiac Magnetic Resonance Imaging
Change from baseline in left ventricular end-diastolic volume (LVEDV) measured by cardiac magnetic resonance imaging, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline, 6 months
Change in stroke volume (SV) by Cardiac Magnetic Resonance Imaging
Change from baseline in stroke volume (SV) measured by cardiac magnetic resonance imaging, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline and 6 months
Change in Myocardial Late Gadolinium Enhancement Volume by Cardiac Magnetic Resonance Imaging
Change from baseline in myocardial late gadolinium enhancement (LGE) volume percentage measured by cardiac magnetic resonance imaging, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline and 6 months
Change in Extracellular Volume Fraction in Remote Myocardium by Cardiac Magnetic Resonance Imaging
Change from baseline in extracellular volume fraction (ECV) in remote myocardium measured by cardiac magnetic resonance imaging, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline and 6 months
Change in Myocardial Scar Transmurality by Cardiac Magnetic Resonance Imaging
Change from baseline in myocardial scar transmurality percentage measured by cardiac magnetic resonance imaging, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline and 6 months
Change in Serum B-type Natriuretic Peptide (BNP) Level
Change from baseline in serum B-type natriuretic peptide (BNP) level, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline, 3 months, and 6 months
Change in Six-Minute Walk Test Distance
Change from baseline in six-minute walk test distance, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline, 3 months, and 6 months
Change in Heart Failure Symptom Assessments--NYHA
Change from baseline in heart failure symptom and functional status assessments, including New York Heart Association (NYHA) functional class, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline, 3 months, and 6 months
Change in Heart Failure Symptom Assessments--INTERMACS
Change from baseline in heart failure symptom and functional status assessments, including INTERMACS profile, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline, 3 months, and 6 months
Change in Heart Functional Status Assessments-KCCQ
Change from baseline in heart failure symptom and functional status assessments, including Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline, 3 months, and 6 months
Change in Cardiac 18F-FAPI Uptake by PET/CT
Change from baseline in cardiac 18F-FAPI maximum standardized uptake value (SUVmax) measured by positron emission tomography/computed tomography (PET/CT), and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame: Baseline and 6 months
Incidence of Major Adverse Cardiovascular Events
Incidence of major adverse cardiovascular events (MACE), including all-cause death, hospitalization for heart failure, myocardial infarction, and stroke, in the iCDC treatment group and the standard treatment control group.
Time frame: Up to 6 months
Incidence of Adverse Events
Incidence of adverse events in the iCDC treatment group and the standard treatment control group. Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events, version 5.0.
Time frame: Up to 6 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Second Affiliated Hospital, School of Medicine, Zhejiang University