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

NCT07516288 | Recruiting Phase 1

• 1 other identifier: YAN2026-0117
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the safety and preliminary efficacy of a second administration of fibroblast activation protein (FAP)-targeted immunosuppressive chimeric antigen receptor dendritic cells (CAR-DC) in patients with end-stage dilated cardiomyopathy. Previous clinical research has shown that single-dose CAR-DC therapy is safe and may provide clinical benefit. However, some patients experience recurrent worsening of heart function after initial treatment. This study will assess whether a second CAR-DC infusion is safe and whether it can further improve cardiac function in this patient population.

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 (14)

• 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

All participants will receive a second infusion of CAR-DC at the predetermined safe and effective dose of 4×10⁵ cells/kg, administered intravenously.

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:

• ≥18 years and ≤75 years of age, with a confirmed diagnosis of dilated cardiomyopathy.
• Patients who previously received a single infusion of immunosuppressive CAR-DC (iCDC) therapy and, at 6 months after the first treatment, failed to maintain improvement in cardiac function, with cardiac function declining to baseline levels prior to treatment. These patients should have persistent heart failure symptoms that cannot be adequately improved, with left ventricular ejection fraction (LVEF) \<35%, New York Heart Association (NYHA) functional class III-IV, and INTERMACS profile 3-6.
• Able to verbally confirm understanding of the risks, benefits, and alternative treatment options of the second administration of iCDC therapy, and willing to participate in the study. The participant or his/her legal representative must provide written informed consent prior to enrollment.
• Hematocrit \>30%, lymphocyte count \>0.5 × 10⁹/L, and platelet count \>60 × 10⁹/L.

You may not qualify if:

• Severe renal failure or requirement for renal dialysis, or serum creatinine \>2.5 mg/dL.
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 5.0 times the upper limit of normal (ULN), or total bilirubin \>3 mg/dL.
• Presence of active infections at screening, including: Active hepatitis B infection with hepatitis B virus DNA \>1000 copies/mL by PCR testing; Hepatitis C virus infection; Syphilis; Human immunodeficiency virus (HIV) infection; Uncontrolled systemic fungal, bacterial, viral, or other pathogenic infections.
• Severe hemodynamic instability (e.g., shock).
• Known contraindications to the investigational product or study-related procedures.

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang / 浙江, 310009, China

RECRUITING

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

  Second Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiamin Li, MD

CONTACT

86-18868112006; 21818216@zju.edu.cn

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 24, 2026
• First Posted: April 7, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)