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

NCT06902896 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: YAN2024-1210
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dilated Cardiomyopathy (DCM); Heart Failure

Keywords

end-stage dilated cardiomyopathy; FAP immunosuppressive CAR-DC

Outcome Measures

Primary Outcomes (2)

• The proportion of subjects with Dose-limiting toxicity (DLT)

  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)

  Incidence of iCDC treatment-emergent adverse events

  in 14 days after injection

Secondary Outcomes (13)

• Left ventricular ejection fraction (LVEF)

  1, 3, 6 months after injection

• Left ventricular ejection fraction (LVEF)

  6 months after injection

• Enhanced volume (volume%)

  6 months after injection

• INTERMACS Profile

  1, 3, 6 months after injection

• Left ventricular internal diameter end systole (LVIDs)

  1, 3, 6 months after injection

Study Arms (1)

dilated cardiomyopathy

EXPERIMENTAL

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

Interventions

FAP immunosuppressive CAR-DC BIOLOGICAL

Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion

dilated cardiomyopathy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Heart Failure

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Xinyang Hu, PhD

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 30, 2025
• Study Start: April 22, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)