NCT04211675

NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 29 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed Neuroblastoma
• Refractory Neuroblastoma

Interventions

Type	Name	Description
BIOLOGICAL	Natural Killer Cells	NK cells dose 1x 108 cells/ kg on day 8 of each cycle
DRUG	Temozolomide	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.
DRUG	Irinotecan	Irinotecan 50mg/m2/dose IV daily on Days 1-5
DRUG	Dinutuximab	Dinutuximab 17.5mg/m2/dose IV daily on Days 2-5
DRUG	Sargramostim	Sargramostim 250mcg/m2/dose subcutaneous daily on Days 6-12

Timeline

• Start date: 2022-09-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2019-12-26
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study