A Phase I/II Safety Lead in Study of Ex-Vivo Expanded Allogeneic Universal Donor TGFβi NK Cell Infusions in Combination With Irinotecan, Temozolomide, and Dinutuximab in Patients With Relapsed or Refractory Neuroblastoma: The Allo - STING Trial
Summary
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.
Arms & interventions
- BiologicalNatural Killer Cells
NK cells dose 1x 108 cells/ kg on day 8 of each cycle
- DrugTemozolomide
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.
- DrugIrinotecan
Irinotecan 50mg/m2/dose IV daily on Days 1-5
- DrugDinutuximab
Dinutuximab 17.5mg/m2/dose IV daily on Days 2-5
- DrugSargramostim
Sargramostim 250mcg/m2/dose subcutaneous daily on Days 6-12
Outcome measures
Primary
NK 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
Secondary
Toxicity Definition of NK cells
Time frame: 36 months
Eligibility criteria
Study locations (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205