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

Korábbi kezelés

• Any systemic anti-cancer therapy, including chemotherapy or immunotherapy, within 3 weeks before 1st dose of GM-CSF
• The participant use drugs that will strongly inhibit CYP2D6 or CYP3A activity.

Más betegség

• Active life-threatening infection
• History of allergy or intolerance to study drug components.
• The participant is known to be allergy to Eliglustat.

Egyéb

• Existing major organ dysfunction > Grade 2, with the exception of hearing loss, hematological status, kidney and liver function
• The participant is CYP2D6 ultra-rapid metabolizer.

• Neuroblastoma must be documented at the point of diagnosis, which is defined as one of the following: histopathology of a biopsy of a solid tumour; bone marrow aspirate or biopsy suggestive of neuroblastoma with elevated blood or urine catecholamine metabolite levels.
• The participant is at least 6years old at time of enrollment.
• At least one measurable lesion at baseline according to RECIST version 1.1.
• Have adequate organ function as assessed by the laboratory required by protocol, which should be confirmed within 2 weeks prior to the first dose of study drugs.
• Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to <= grade 1 toxicity.
• Eastern Cooperative Oncology Group (ECOG) performance status score≤2 and Estimated life expectancy of more than 3 months.
• Patient(and/ or their parent/ legal guardian) is willing to participate and able to provide signed informed consent.