NCT07516288

Safety and Efficacy of Second Infusion of FAP iCDC in End-stage Dilated Cardiomyopathy

Safety and Efficacy of Second Infusion of Autologous Immunosuppressive CAR-DC Targeting FAP in the Treatment of End-stage Dilated Cardiomyopathy

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and preliminary efficacy of a second administration of fibroblast activation protein (FAP)-targeted immunosuppressive chimeric antigen receptor dendritic cells (CAR-DC) in patients with end-stage dilated cardiomyopathy. Previous clinical research has shown that single-dose CAR-DC therapy is safe and may provide clinical benefit. However, some patients experience recurrent worsening of heart function after initial treatment. This study will assess whether a second CAR-DC infusion is safe and whether it can further improve cardiac function in this patient population.

Detailed description

Heart failure is a life-threatening syndrome with high morbidity and mortality. Dilated cardiomyopathy (DCM) is a major cause of end-stage heart failure, and currently available treatments for advanced DCM remain limited. Immune activation and myocardial fibrosis play key roles in the progression of heart failure. Targeting cardiac fibrosis through immune modulation has emerged as a potential therapeutic strategy. Our research group has developed a novel immunosuppressive chimeric antigen receptor-modified dendritic cell (CAR-DC) therapy targeting fibroblast activation protein (FAP), designed to reduce cardiac fibrosis and improve cardiac function. Preclinical studies demonstrated that FAP-targeted immunosuppressive CAR-DC (iCDC) therapy significantly improved cardiac function and survival in animal models of heart failure, with a favorable safety profile. Based on these findings, an exploratory clinical study of single-dose iCDC infusion in patients with end-stage DCM has been conducted, and preliminary follow-up results up to three months have shown good safety and potential clinical benefit. However, in clinical practice, patients with end-stage DCM may experience recurrent deterioration of cardiac function due to infections or other triggers. Whether a second administration of iCDC can restore or further improve cardiac function remains unknown. Therefore, this study aims to evaluate the safety and preliminary efficacy of a second infusion of FAP-targeted immunosuppressive CAR-DC in patients with end-stage dilated cardiomyopathy who experience worsening heart function after initial treatment.

Conditions

• Dilated Cardiomyopathy (DCM)
• Heart Failure

Interventions

Type	Name	Description
BIOLOGICAL	FAP immunosuppressive CAR-DC	Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion

Timeline

• Start date: 2026-04-15
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-04-07
• Last updated: 2026-04-07