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NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

Phase II Study of Ex-Vivo Expanded Allogeneic Universal Donor TGFβi NK Cell Infusions in Combination With Temozolomide, Irinotecan, Dinutuximab, and Sargramostim in Patients With Relapsed or Refractory Neuroblastoma The STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial

NCT06450041•New Approaches to Neuroblastoma Therapy Consortium

View on ClinicalTrials.gov

Summary

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

Detailed Description

Currently there are very few effective treatments for high-risk neuroblastoma that has returned or that has not responded to treatment. One treatment that works relatively well for this type of neuroblastoma is a combination of four medicines (dinutuximab, temozolomide, irinotecan, and GM-CSF). Dinutuximab is an antibody that attacks neuroblastoma cells. Temozolomide and irinotecan are two chemotherapy medicines. GM-CSF helps to boost the immune system. This study is trying to learn if this treatment, which is called chemoimmunotherapy, can work better by adding NK cells. The immune system is made up of different cell types. One type of immune cell is the natural killer (NK) cell. NK cells use the body's defense (immune) system to kill neuroblastoma cells. NK cells are only present in the body in small numbers and often the patient's own NK cells don't work very well against their tumor because neuroblastoma releases chemicals that weaken the NK cells. One of these chemicals is called TGF-beta. This study uses a newer process to make specially chosen donated NK cells which may work better than the patient's own NK cells. This new type of donated NK cells are called TGF-beta imprinted, which may be better "killers" of tumors like neuroblastoma because they have already been exposed to TGF-beta while they are being prepared and grown. The special NK cells for this study have already been collected from donors selected for this study and are stored for use. Prior studies have used these types of NK cells or similar NK cells for other tumors or neuroblastoma. Once treatment begins, patients will receive temozolomide and irinotecan for 5 consecutive days, with the addition of dinutuximab daily on days 2-5. If patients tolerate this chemoimmunotherapy, they will receive the donor TGF-beta NK cells on day 8. Patients can have this treatment for up to 6 cycles total.

Eligibility

Age

1 - 31 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must be ≥ 1 year and ≤31 years of age at the time of enrollment on the study.
•Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines.
•Patients must have high-risk neuroblastoma according to COG risk classification at the time of study registration. Patients whose disease was initially considered low or intermediate risk but then reclassified as high-risk neuroblastoma prior to enrollment also meet this criteria.
•Patients must have at least ONE of the following:
•1\) Recurrent/progressive disease after the diagnosis of high risk neuroblastoma at any time prior to enrollment - regardless of response to frontline therapy. (Note that this excludes patients initially considered low or intermediate risk that progressed to high risk disease but have not progressed after the diagnosis of high risk neuroblastoma).
•2\) If no prior history of recurrent/progressive disease since the diagnosis of high-risk neuroblastoma,
•2a) Refractory disease: A best overall response of no response/stable disease since diagnosis of high-risk neuroblastoma AND after at least 4 courses of induction therapy.
•2b) Persistent disease: A best overall response of partial response since diagnosis of high-risk neuroblastoma AND after at least 4 courses of induction therapy
•Patients must have at least ONE of the following (lesions may have received prior radiation therapy as long as they meet the other criteria listed below) based on institutional assessment:
•1\) Bone Sites
+58 more criteria

Exclusion Criteria

•Patients who are pregnant, breast feeding, or unwilling to use effective contraception during the study
•Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
•Patients with disease of any major organ system that would compromise their ability to withstand therapy.
•Patients with \> Grade 2 diarrhea.
•Patients who have undergone a prior allogeneic stem cell or solid organ transplant.
•Patients who are on hemodialysis.

Locations (13)

Children's Hospital Los Angeles

Los Angeles, California, United States

UCSF Benioff Children's Hospital

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Comer Children's Hospital, University of Chicago

Chicago, Illinois, United States

Boston Children's Hospital, Dana-Farber Cancer Institute.

Boston, Massachusetts, United States

C.S Mott Children's Hospital

Ann Arbor, Michigan, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Key Dates

Start Date

December 16, 2024

Primary Completion Date

December 1, 2028

Completion Date

December 1, 2038

Last Updated

November 4, 2025

Enrollment

ESTIMATED participants

Conditions

Neuroblastoma

Interventions

Universal Donor (UD) TGFβi NK Cells

DRUG

Temozolomide

DRUG

Irinotecan

DRUG

Dinutuximab

DRUG

GM-CSF

DRUG

Contacts

Araz Marachelian, MD

CONTACT

3233615687 nantops@chla.usc.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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