Dilated Cardiomyopathy (DCM)Phase 1/2NCT06902896
Safety and Efficacy of FAP iCDC in End-stage Dilated Cardiomyopathy
A Phase 1/2 study testing FAP immunosuppressive CAR-DC in people with Dilated Cardiomyopathy (DCM) and Heart Failure, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dilated Cardiomyopathy (DCM), Heart Failure
- What is being tested?
- FAP immunosuppressive CAR-DC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2025to 31 Dec 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pulmonary Embolism (PE).
- A history of tuberculosis.
- History of severe renal failure or need for dialysis, creatinine >2.5 mg/dl.
- Uncorrected thrombocytopenia or systemic coagulopathy (platelet count < 50,000, INR > 2.5, or aPTT > 2.5 times control in the absence of anticoagulation), or active bleeding and uncorrectable coagulopathy.
- Aspartate aminotransferase or alanine aminotransferase levels greater than 5.0 times the upper limit of normal (ULN), total bilirubin >3 mg/dl.
- History of concurrent severe infection, hepatobiliary obstruction, or malignancy.
- Infections: Active hepatitis B (PCR-detected hepatitis B virus DNA copies > 1000), hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection at screening; uncontrolled systemic fungal, bacterial, viral, or other pathogen infection.
- Severe hemodynamic instability (eg, shock).
- Women who are pregnant or may become pregnant.
- Contraindications to study drugs or tests.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Xinyang Hu, 86-0571-87783777, hxy0507@zju.edu.cn
About this study
Official title: Safety and Efficacy of Immunosuppressive CAR-DC Targeting FAP in the Treatment of End-stage Dilated Cardiomyopathy
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.
Read the detailed description
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.
- Conditions
- Dilated Cardiomyopathy (DCM), Heart Failure
- Being tested
- FAP immunosuppressive CAR-DC
- Keywords
- end-stage dilated cardiomyopathy, FAP immunosuppressive CAR-DC
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAP immunosuppressive CAR-DCBiological
Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| iCDC Therapy | Experimental | 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. Receives: Biological: FAP immunosuppressive CAR-DC |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with Dose-limiting toxicity (DLT)
The proportion of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: in 14 days after injection
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of iCDC treatment-emergent adverse events
Measured: in 14 days after injection
Secondary outcomes (13)
Left ventricular ejection fraction (LVEF)
The difference of LVEF from baseline. LVEF will be assessed by echocardiography.
Measured: 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).
Measured: 6, 12 months after injection
Enhanced volume (volume%)
The difference of Enhanced volume (volume%) from baseline. Enhanced volume will be assessed by CMR.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 , 12 months after injection
Left ventricular end-diastolic volume (LVEDV)
The difference of LVEDV from baseline. LVEDV will be assessed by CMR.
Measured: 6 , 12 months after injection
NT-proBNP
Analysis of differences of NT-proBNP serum level from baseline.
Measured: 1, 3, 6 , 12 months after injection
6 minutes walk test (6MWT)
The difference of 6MWT from baseline.
Measured: 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.
Measured: 1, 3, 6, 12 months after injection
Incidence of major adverse cardiovascular events (MACE)
Incidence of Cardiac death, readmission due to heart failure.
Measured: 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.
Measured: 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start22 Apr 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated Cardiomyopathy (DCM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a two-phase interventional study. Phase 1 will employ a modified single-arm 3+3 dose-escalation design to evaluate the safety, dose-limiting toxicities, treatment-related adverse events, and preliminary efficacy of iCDC therapy, and to establish a safe and effective dose for further evaluation. Once the safe and effective dose is determined, enrollment at that dose will be expanded to a total of 8-10 participants in Phase 1 to further assess safety and preliminary efficacy. In Phase 2, the study will be expanded at the safe and effective dose identified in Phase 1. An additional 15 participants will receive iCDC therapy at this dose, and 20 participants will be enrolled as a non-randomized concurrent control group for exploratory comparison.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinyang Hu, PhD, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902896
- Sponsor's protocol ID
- YAN2024-1210
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No