RecruitingPhase 1Phase 2NCT04211675

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

Sponsor

Nationwide Children's Hospital

Enrollment

31 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Refractory Neuroblastoma Relapsed Neuroblastoma

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

Max Age: 29 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of natural killer (NK) cell infusions with chemotherapy drugs (irinotecan and temozolomide) and a targeted antibody (dinutuximab) to treat relapsed or refractory neuroblastoma in children and young adults. **You may be eligible if...** - You are under 30 years old - You have been diagnosed with neuroblastoma or ganglioneuroblastoma confirmed by biopsy or bone marrow findings - Your cancer has relapsed, is progressing during treatment, or has not responded to at least 4 cycles of induction chemotherapy - Your life expectancy is more than 2 months - You have measurable or evaluable disease on MRI, CT, or other imaging **You may NOT be eligible if...** - You are 30 years of age or older - Your neuroblastoma has not been histologically confirmed - Your disease does not meet the response criteria (relapsed, progressive, or refractory) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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