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

April 3, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Immune system activation and myocardial fibrosis are widely observed in patients with heart failure, whether it is ischemic or non-ischemic heart failure. Therefore, targeting inflammation and cardiac fibrosis may become a universal therapeutic strategy for the treatment of heart failure. At present, T cell surface molecular group modification (such as CAR-T) has been found to reduce fibrosis and restore cardiac function after injury in rodent heart failure models, suggesting that immune cells may be one of the potential effective targets for the treatment of heart failure. Dendritic cells (DCs) are the most powerful professional antigen-presenting cells in the body. Immature DCs have strong migration ability, and mature DCs can effectively activate naive T cells, which are at the center of initiating, regulating, and maintaining immune responses. Studies have confirmed that dendritic cells are involved in regulating inflammatory responses after myocardial injury.

Here, we innovatively applied chimeric antigen receptor (CAR) technology to edit DCs, making the new CAR immune cells exhibit an immunosuppressive phenotype, leading to T cell tolerance to CAR immune cells without producing new antigens; and targeting fibroblast activation protein (FAP) to accumulate in the fibrotic area of cardiac injury, thereby reducing fibrosis and enhancing cardiac function.

Purpose: To evaluate the efficacy and safety of immunosuppressive CAR-DC (iCDC) in the treatment of patients with end-stage dilated cardiomyopathy.

Study design: This study is a prospective, single-center, single-arm clinical study. The study objects are patients aged 18 to 75 years with end-stage dilated cardiomyopathy (ejection fraction < 35%) who visited the Department of Cardiology. In this study, patients with end-stage dilated cardiomyopathy were proposed to undergo FAP iCDC Cell therapy.

Outcome measure: The primary outcome is evaluation of the safety of FAP iCDC for end-stage dilated cardiomyopathy. The secondary outcomes are left ventricular ejection fraction (LVEF) assessed by echocardiography and cardiac magnetic resonance, enhanced volume assessed by cardiac magnetic resonance, interagency registry for mechanically assisted circulatory support (INTERMACS) grade, left ventricular internal dimension in systole (LVIDs), left ventricular internal dimension in diastole (LVIDd), left ventricular end-systolic volume (LVESV), left ventricular end-diastolic volume (LVEDV), N-terminal prohormone of brain natriuretic peptide (NT pro-BNP), 6 minutes walk test (6-MWT), New York Heart Association (NYHA) classification, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, incidence of major adverse cardiac events (MACE) and adverse events.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 ⅢB-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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: dilated cardiomyopathy

Administration of FAP immunosuppressive CAR-DC cell therapy in dilated cardiomyopathy.

Patients are planned to be enrolled in the dose-escalation trial (1×10^5/kg、4×10^5/kg、and 8×10^5/kg) .The first dose group (4×10⁵/kg) initially enrolls 3 subjects to observe Dose-Limiting Toxicity (DLT) responses.

  1. If no DLT occurs and all 3 subjects demonstrate efficacy after 6 months of treatment, and this dose is determined as the safe and effective dose.

  2. If 1 subject experiences DLT, 3 additional subjects are enrolled.

    • If 1/6 subjects develops DLT, and efficacy is not fully achieved in all 6 subjects, escalate to the next dose group (8×10^5/kg).
    • If ≥2/6 subjects develop DLT, de-escalate to the previous dose group (1×10^5/kg). （3）After identifying a safe and effective dose, enrollment will be expanded at this dose to bring the total sample size to 8-10 subjects, to further evaluate safety and efficacy.
Biological: FAP immunosuppressive CAR-DC
Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The proportion of subjects with Dose-limiting toxicity (DLT)
Time Frame: in 14 days after injection
The proportion of participants with treatment-related adverse events as assessed by CTCAE v5.0
in 14 days after injection
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: in 14 days after injection
Incidence of iCDC treatment-emergent adverse events
in 14 days after injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction (LVEF)
Time Frame: 1, 3, 6 months after injection
The difference of LVEF from baseline. LVEF will be assessed by echocardiography.
1, 3, 6 months after injection
Left ventricular ejection fraction (LVEF)
Time Frame: 6 months after injection
The difference of LVEF from baseline. LVEF will be assessed by Cardiac Magnetic Resonance (CMR).
6 months after injection
Enhanced volume (volume%)
Time Frame: 6 months after injection
The difference of Enhanced volume (volume%) from baseline. Enhanced volume will be assessed by CMR.
6 months after injection
INTERMACS Profile
Time Frame: 1, 3, 6 months after injection
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
1, 3, 6 months after injection
Left ventricular internal diameter end systole (LVIDs)
Time Frame: 1, 3, 6 months after injection
The difference of LVIDs from baseline. LVIDs will be assessed by echocardiography.
1, 3, 6 months after injection
Left ventricular internal diameter end diastole (LVIDd)
Time Frame: 1, 3, 6 months after injection
The difference of LVIDd from baseline. LVIDd will be assessed by echocardiography.
1, 3, 6 months after injection
Left ventricular end-systolic volume (LVESV)
Time Frame: 6 months after injection
The difference of LVESV from baseline. LVESV will be assessed by CMR.
6 months after injection
Left ventricular end-diastolic volume (LVEDV)
Time Frame: 6 months after injection
The difference of LVEDV from baseline. LVEDV will be assessed by CMR.
6 months after injection
NT-proBNP
Time Frame: 1, 3, 6 months after injection
Analysis of differences of NT-proBNP serum level from baseline.
1, 3, 6 months after injection
6 minutes walk test (6MWT)
Time Frame: 1, 3, 6 months after injection
The difference of 6MWT from baseline.
1, 3, 6 months after injection
assessment of heart failure symptom
Time Frame: 1, 3, 6 months after injection
The difference of heart failure symptom, which will be assessed by NYHA grading and KCCQ score.
1, 3, 6 months after injection
Incidence of major adverse cardiovascular events (MACE)
Time Frame: 1, 3, 6 months after injection
Incidence of Cardiac death, readmission due to heart failure.
1, 3, 6 months after injection
incidence of adverse events
Time Frame: 6 months
Incidence of adverse events of heart, nerve system, mental system, digestive system and immune system.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xinyang Hu, PhD, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YAN2024-1210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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