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NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab

NCT04211675 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-05-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Mark Ranalli, MD · Nationwide Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04211675 on ClinicalTrials.gov