Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Phase 1
Started
2026-05-11
Last updated
2026-07-02
Condition(s) studied
Dilated Cardiomyopathy (DCM)Heart Failure
Investigational drug(s) / intervention(s)
FAP immunosuppressive CAR-DC
FAP immunosuppressive CAR-DC: Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* ≥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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
The proportion of subjects with Dose-limiting toxicity (DLT) — in 14 days after injection The proportion of participants with treatment-related adverse events as assessed by CTCAE v5.0
Incidence of treatment-emergent adverse events (TEAEs) — in 14 days after injection Incidence of iCDC treatment-emergent adverse events
Trial sites (1)
Facility
City
Region
Status
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
Zhejiang / 浙江
Recruiting
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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