Safety and Efficacy of FAP iCDC in End-stage Dilated Cardiomyopathy (NCT06902896) | Clinical Trial Compass
CompletedPhase 1
Safety and Efficacy of FAP iCDC in End-stage Dilated Cardiomyopathy
China8 participantsStarted 2025-04-22
Plain-language summary
To study the safety and efficacy of fibroblast activation protein (FAP)-targeted immunosuppressive chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of end-stage dilated cardiomyopathy and provide a new method for the treatment of end-stage dilated cardiomyopathy.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18 years old and 75 years old, diagnosed with dilated cardiomyopathy.
* Able to verbally confirm that he/she understands the risks, benefits and treatment options of the iCDC trial. He/she or his/her legal representative provides written informed consent before participating in the clinical trial.
* Diagnosed with Heart Failure with reduced ejection fraction (HFrEF), optimized drug therapy (under maximum tolerance of GDMT) for at least 3 months, left ventricular ejection fraction \<35%, NYHA functional class â…¢B-IV, INTERMACS class 3-6.
* Blood test: hematocrit \>30%, lymphocytes \>0.5×10\^9/L, platelets \>60×10\^9/L.
Exclusion Criteria:
* History of myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks before enrollment.
* CRT implanted within 12 weeks before enrollment or intended to implant CRT device.
* Previous heart transplantation or implantation of a ventricular assist device or similar device, or planned implantation of a ventricular assist device or similar device.
* Heart failure caused by ischemic cardiomyopathy, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, long-standing hypertension, congenital structural heart disease, or uncorrected primary valvular disease.
* Symptomatic bradycardia or second/third degree heart block.
* Active autoimmune disease requiring immunosuppressive therapy.
* Pulmonary Embolism (PE).
* A his…
What they're measuring
1
The proportion of subjects with Dose-limiting toxicity (DLT)
Timeframe: in 14 days after injection
2
Incidence of treatment-emergent adverse events (TEAEs)
Timeframe: in 14 days after injection
Trial details
NCT IDNCT06902896
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University