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NOT YET RECRUITING

NCT07505199

PHASE1

Safety and Efficacy of FAP iCDC in Ischemia Cardiomyopathy

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

To study the safety and efficacy of fibroblast activation protein (FAP)-targeted autologus immunosuppressive chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of ischemic cardiomyopathy, aiming to provide a novel therapeutic strategy for the disease.

Official title: Safety and Efficacy of Immunosuppressive CAR-DC Targeting FAP in the Treatment of Ischemia Cardiomyopathy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-01

Completion Date

2029-04-01

Last Updated

2026-04-01

Healthy Volunteers

Conditions

Ischemic Cardiomyopathy Cell Therapy

Interventions

BIOLOGICAL

autologus FAP-targeted immunosuppressive CAR-DCs (iCDC)

Each subject receives FAP-targeted immunosuppressive CAR-DCs by intravenous infusion after enrollment.

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. 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 \<15 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.