This is a Phase 1 study with Phase 2 expansion cohort. Phase 1 will assess the safety and tolerability of universal donor TGFβi NK Cell in combination with irinotecan, temozolomide, and dinituximab. The phase 2 of the study will estimate the response to treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
NK cells dose 1x 108 cells/ kg on day 8 of each cycle
Temozolomide 100mg/m2/dose PO or IV daily on Days 1-5; if given orally, must be at least one hour prior to Irinotecan. For patients whose body surface area is \<0.5m2, temozolomide dosing is based on body weight in (kg), at a dose of 3.3 mg/kg/dose.
Irinotecan 50mg/m2/dose IV daily on Days 1-5
Nationwide Children's Hospital
Columbus, Ohio, United States
RECRUITINGNK cells safety and tolerability: Number of participants with treatment-related adverse events and toxicities
Number of participants with treatment-related adverse events and toxicities as assessed by CTCAE v4.0
Time frame: 12 months
Response to NK Cell treatment as determine by CT/MRI imaging
To estimate the response to treatment, as determined by disease status evaluated using CT/MRI scans through the measuring tool RECIST.
Time frame: 24 months
Response to NK Cell treatment as determine by MIBG scans imaging
To estimate the response to treatment, as determined by disease status evaluated using MIBG scans through the Curie score system.
Time frame: 24 months
Response to NK Cell treatment as determine by bone marrow aspiration
To estimate the response to treatment, as determined by disease status evaluated using bone marrow aspiration and biopsy through H\&E stain. RECIST.
Time frame: 24 months
Toxicity Definition of NK cells
Toxicity will be graded using the CTCAE criteria, version 5.0. All grade 3+ toxicities will be reviewed for attribution.
Time frame: 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dinutuximab 17.5mg/m2/dose IV daily on Days 2-5
Sargramostim 250mcg/m2/dose subcutaneous daily on Days 6-12