Safety and Efficacy of FAP iCDC in End-stage Dilated Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 ⅢB-IV, INTERMACS class 3-6.
Blood test: hematocrit >30%, lymphocytes >0.5×10^9/L, platelets >60×10^9/L.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
FAP immunosuppressive CAR-DC
Biological/VaccineEach subject receive FAP immunosuppressive CAR-DC by intravenous infusion
Treatment groups
43 Participants
are divided into 2 treatment groupsGroup A: iCDC TherapyExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The proportion of subjects with Dose-limiting toxicity (DLT)
The proportion of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame
in 14 days after injection2
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of iCDC treatment-emergent adverse events
Time frame
in 14 days after injectionSecondary outcomes
1
Left ventricular ejection fraction (LVEF)
The difference of LVEF from baseline. LVEF will be assessed by echocardiography.
Time frame
1, 3, 6, 12 months after injection2
Left ventricular ejection fraction (LVEF)
The difference of LVEF from baseline. LVEF will be assessed by Cardiac Magnetic Resonance (CMR).
Time frame
6, 12 months after injection3
Enhanced volume (volume%)
The difference of Enhanced volume (volume%) from baseline. Enhanced volume will be assessed by CMR.
Time frame
6 , 12 months after injection4
INTERMACS Profile
Profile 1. Critical cardiogenic shock; Profile 2. Progressive decline on inotropic support; Profile 3. Stable but inotrope dependent; Profile 4. Resting symptoms home on oral therapy; Profile 5. Exertion Intolerant; Profile 6. Exertion Limited; Profile 7. Advanced NYHA Class III symptoms
Time frame
1, 3, 6 , 12 months after injectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov