A Phase 1/2 interventional study of FAP immunosuppressive CAR-DC in Dilated Cardiomyopathy (DCM) and Heart Failure, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 1/2, Interventional, and Treatment
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.
This study aims to evaluate the safety and efficacy of fibroblast activation protein (FAP)-targeted immunosuppressive chimeric antigen receptor-dendritic cell (iCDC) therapy in patients with end-stage dilated cardiomyopathy, and to provide a novel therapeutic approach for this condition. This is a prospective, single-center, open-label, two-phase clinical study designed to assess the safety and preliminary efficacy of iCDC in patients with end-stage dilated cardiomyopathy.
Phase 1 employs a single-arm, 3+3 dose-escalation design. iCDC therapy will be administered at predefined dose levels to evaluate safety, dose-limiting toxicities, treatment-related adverse events, and preliminary efficacy, and to determine the safe and effective dose.
Phase 2 will expand enrollment at the safe and effective dose identified in Phase 1. Additional patients will receive iCDC therapy at this dose, and a non-randomized concurrent control group will also be enrolled. Control participants must meet the same eligibility criteria and, after providing informed consent, choose not to receive iCDC therapy but agree to participate in study follow-up. They will not undergo leukapheresis, iCDC manufacturing, or cell infusion, and will continue to receive guideline-directed standard medical therapy. The iCDC treatment group will be assessed for safety and preliminary efficacy. The concurrent control group will be followed using clinically feasible shared assessments, including echocardiography, BNP or NT-proBNP, 6-minute walk distance, NYHA functional class, INTERMACS profile, KCCQ score, worsening heart failure, hospitalization, death, and major cardiovascular events. Cardiac magnetic resonance imaging and cell therapy-specific assessments will be performed exclusively in participants receiving iCDC therapy and will not be included in between-group comparisons with the control group.
253 studies on the registry are indexed under Cardiomyopathy, Dilated; 65 are open to participants now.
This study's planned enrollment of 43 is close to the median of 40 across 143 interventional studies indexed under Cardiomyopathy, Dilated.
Browse Cardiomyopathy, Dilated studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm will receive FAP-targeted immunosuppressive chimeric antigen receptor-dendritic cell (iCDC) therapy. In Phase 1, iCDC will be administered at predefined dose levels (1×10⁵, 4×10⁵, and 8×10⁵ cells/kg) using a modified single-arm 3+3 dose-escalation design. Safety and preliminary efficacy will be evaluated at each dose level. If a given dose level is deemed safe and effective at 1 month post-treatment, it will be selected as the safe and effective dose, and no further dose escalation will be pursued. Otherwise, dose escalation may proceed to the next predefined level in accordance with the protocol. In Phase 2, additional participants will receive iCDC therapy at the safe and effective dose identified in Phase 1.
Biological: FAP immunosuppressive CAR-DC
Participants in this arm will be enrolled in Phase 2 as a non-randomized concurrent control group. They must meet the eligibility criteria and, after providing informed consent, elect not to receive iCDC therapy but agree to study follow-up. These participants will not undergo leukapheresis, iCDC manufacturing, or cell infusion, and will continue to receive guideline-directed standard medical therapy. They will be followed using clinically feasible shared assessments for exploratory comparison with the iCDC therapy arm.
Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion
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 injection
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of iCDC treatment-emergent adverse events
Time frame: in 14 days after injection
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 injection
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 injection
Enhanced volume (volume%)
The difference of Enhanced volume (volume%) from baseline. Enhanced volume will be assessed by CMR.
Time frame: 6 , 12 months after injection
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 injection
Left ventricular internal diameter end systole (LVIDs)
The difference of LVIDs from baseline. LVIDs will be assessed by echocardiography.
Time frame: 1, 3, 6 , 12 months after injection
Left ventricular internal diameter end diastole (LVIDd)
The difference of LVIDd from baseline. LVIDd will be assessed by echocardiography.
Time frame: 1, 3, 6 , 12 months after injection
Left ventricular end-systolic volume (LVESV)
The difference of LVESV from baseline. LVESV will be assessed by CMR.
Time frame: 6 , 12 months after injection
Left ventricular end-diastolic volume (LVEDV)
The difference of LVEDV from baseline. LVEDV will be assessed by CMR.
Time frame: 6 , 12 months after injection
NT-proBNP
Analysis of differences of NT-proBNP serum level from baseline.
Time frame: 1, 3, 6 , 12 months after injection
6 minutes walk test (6MWT)
The difference of 6MWT from baseline.
Time frame: 1, 3, 6 , 12 months after injection
assessment of heart failure symptom
The difference of heart failure symptom, which will be assessed by NYHA grading and KCCQ score.
Time frame: 1, 3, 6, 12 months after injection
Incidence of major adverse cardiovascular events (MACE)
Incidence of Cardiac death, readmission due to heart failure.
Time frame: 1, 3, 6, 12 months after injection
incidence of adverse events
Incidence of adverse events of heart, nerve system, mental system, digestive system and immune system.
Time frame: 6, 12 months
Plan to share: No
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Second Affiliated Hospital, School of Medicine, Zhejiang University