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NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial

NCT06450041 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-03-23

No results posted yet for this study

Summary

This is a phase II study looking at patient response to treatment with the combination dinutuximab, temozolomide, irinotecan, and GM-CSF.

Conditions

Interventions

DRUG

Universal Donor (UD) TGFβi NK Cells

Patients will receive a dose of 1x108 UD TGFβi NK cells/kg per treatment cycle on day 8 of each cycle

DRUG

Temozolomide

Enteral or IV daily on days 1-5 of each cycle For patients ≥ 0.5 m2: 100 mg/m2/dose For patients \< 0.5 m2: 3.3 mg/kg/dose MAXIMUM dose = 200 mg

DRUG

Irinotecan

50mg/m2/dose IV daily on days 1-5 of each cycle

DRUG

Dinutuximab

17.5mg/m2/dose IV daily on days 2-5 of each cycle

DRUG

GM-CSF

250mcg/m2/dose subcutaneous (preferred) or IV daily on days 6-12 of each cycle

Sponsors & Collaborators

  • Nationwide Children's Hospital

    collaborator OTHER

  • United Therapeutics

    collaborator INDUSTRY

  • Children's Neuroblastoma Cancer Fund

    collaborator UNKNOWN

  • New Approaches to Neuroblastoma Therapy Consortium

    lead OTHER

Principal Investigators

  • Keri Streby, MD · Nationwide Children's Hospital

  • Mark Ranalli, MD · Nationwide Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
31 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-16
Primary Completion
2028-12-31
Completion
2038-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT06450041 on ClinicalTrials.gov