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
Nationwide Children's Hospital
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.
Eligibility
- Age range
- Up to 29 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Less than 30 years of age when registered on the study. * Patients must have a histologic verification of neuroblastoma (NBL) or ganglioneuroblastoma or NBL cells in bone marrow with or without elevated urine catecholamines. * Life expectancy \>2 months, AND one of the following: * Recurrent disease; or * First episode of progressive disease (new lesion, increase in size, previous negative bone marrow) during initial multi-drug, induction myelosuppressive therapy; or * Primary resistant/refractory disease (partial, mixed, stable response criteria met) after comple…
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
Location
- Nationwide Children's HospitalColumbus, Ohio