Actively Recruiting
Evaluating Safety and Effectiveness of FAP-Targeted CAR-DC Therapy for Adults with End-Stage Dilated Cardiomyopathy
Led by Second Affiliated Hospital, Zhejiang University, School of Medicine · Updated on 2026-07-14
43
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new therapy called fibroblast activation protein FAP-targeted immunosuppressive chimeric antigen receptor-dendritic cell iCDC therapy for adults with end-stage dilated cardiomyopathy. This clinical study is designed as a prospective, single-center, open-label trial with two phases, aiming to provide a novel treatment option for this serious heart condition. In Phase 1, patients receive iCDC therapy at escalating dose levels administered by intravenous infusion to assess safety, side effects, and early signs of effectiveness. Once a safe and effective dose is identified, Phase 2 will enroll more patients to receive that dose. A separate control group will also be followed without receiving the iCDC therapy but continuing standard heart failure care. The control group will have several key heart health assessments for comparison. Participants will be closely monitored through various evaluations including heart function tests like echocardiography, blood biomarkers such as NT-proBNP, walking tests, symptom assessments, and cardiac MRI for those receiving iCDC therapy. Safety will be checked by tracking treatment side effects and serious heart events. Follow-up visits will occur at regular intervals up to one year after treatment to measure outcomes and monitor participant health.
CONDITIONS
Brief Title
Safety and Efficacy of FAP iCDC in End-stage Dilated Cardiomyopathy
Research Team
J
Jiamin Li, MD
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