Safety and Effectiveness of a Second Dose of FAP-Targeted Immunosuppressive CAR-DC Therapy for Adults With Advanced Dilated Cardiomyopathy

What this Trial Is About

This research aims to evaluate the safety and early effectiveness of a second infusion of fibroblast activation protein FAP-targeted immunosuppressive chimeric antigen receptor dendritic cells CAR-DC in patients with end-stage dilated cardiomyopathy DCM. DCM is a leading cause of severe heart failure, and current treatments for advanced DCM are limited. Previous studies showed that a single CAR-DC infusion is safe and may help, but some patients experience worsening heart function afterward, prompting investigation of a second infusion. Participants will receive a second intravenous infusion of CAR-DC at a set dose of 410 cells per kilogram. This study includes patients who previously had one CAR-DC treatment but whose heart function declined again within six months. The trial focuses on evaluating safety within 14 days after infusion and monitoring heart function over six months using various cardiac measures and functional assessments. During the study, participants will be monitored closely for side effects and heart function changes. Assessments include heart imaging, blood tests, exercise capacity tests, and quality-of-life questionnaires at multiple points over six months after treatment. Researchers will measure safety outcomes such as treatment-related toxicities and adverse events, along with heart function improvements, symptom changes, and major cardiovascular events. The study duration extends through the six-month follow-up period after the second infusion.

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