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NOT YET RECRUITING
NCT07090538
EARLY_PHASE1

GSL Synthetase Inhibitor Plus GM-CSF and/ or Immune Checkpoint Inhibitor in Previously Treated High-Risk Neuroblastoma.

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

This exploratory clinical study will evaluate the efficacy and feasibility of combining a GSL synthase inhibitor with a granulocyte-macrophage colony stimulating factor (GM-CSF) in patients with advanced or metastatic neuroblastoma. Six to eight eligible patients are expected to be treated in this clinical trial: 1) Assessing the anti-tumour effects of GSL synthase inhibitors in combination with immune checkpoint inhibitors and/or GM-CSF; 2) To assess immunological or clinical predictive biomarkers of efficacy and toxicity; and 3) Detecting changes in the tumour microenvironment (TME) and the dynamics of peripheral blood immune cells after treatment with a GSL synthase inhibitor combined with GM-CSF.

Official title: A Single-arm Exploratory Trial of GSL Synthetase Inhibitor Plus Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and/ or Immune Checkpoint Inhibitor in Advanced/Metastatic Neuroblastoma.

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-08-01

Completion Date

2027-08-31

Last Updated

2025-07-29

Healthy Volunteers

No

Conditions

Interventions

DRUG

Eliglustat

Drug: GM-CSF + Eliglustat Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and GSL Synthetase Inhibitor

Locations (2)

Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital

Beijing, China

Department of Pediatrics, The First Medical Center, Chinese PLA General Hospital

Beijing, China