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Phase II STING Trial for Neuroblastoma

This study is testing a new way to treat neuroblastoma (a type of cancer that starts in nerve cells) that has returned or hasn't responded to other treatments. It combines four existing medicines: dinutuximab (an antibody that attacks cancer cells), temozolomide and irinotecan (chemotherapy drugs), and GM-CSF (which boosts the immune system). The study adds special donated natural killer (NK) cells to this treatment. NK cells are immune cells that can kill cancer cells. These donated NK cells are prepared to be better at fighting neuroblastoma. The study aims to see how many patients respond to this combined treatment. You may be able to join if you are between 1 and 31 years old and have a confirmed diagnosis of neuroblastoma. The current recruitment status is unclear.

Study design
This is a Phase II interventional study planning to enroll 62 participants. It is testing a specific combination of drugs and NK cells.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal is measured during treatment cycles (each 21-28 days) and within two weeks after the last treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06450041

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

Recruiting
PHASE2Ages 1–31InterventionalTreatment
New Approaches to Neuroblastoma Therapy Consortium
~62 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Universal Donor (UD) TGFβi NK CellsTemozolomideIrinotecanDinutuximabGM-CSF

At a glance

Recruiting sites
8 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Best Overall Response Rate of Evaluable Patients
Measured over Baseline assessments from within 28 days before Day 1 on study and between days 12-24 of cycles 2, 4, and 6, and within two weeks after the last date of protocol therapy. Each cycle will be 21 days but may be extended to 28 days due to treatment delays.

Conditions

Neuroblastoma

Explore related trials

Neuroblastoma

Where it's being run

13 sites across 10 states
California2
Ohio2
Texas2
Colorado1
Illinois1
Massachusetts1
Michigan1
Pennsylvania1

Study leadership

  • Keri Streby, MD · STUDY_CHAIR · Nationwide Children's Hospital
  • Mark Ranalli, MD · STUDY_CHAIR · Nationwide Children's Hospital

Who to contact

Araz Marachelian, MD
[email protected]
3233615687
Email the study team

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Eligibility criteria

Inclusion

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:
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:
Patients must have a Lansky (≤ 16 years) or Karnofsky (\> 16 years) score of ≥ 50 (Appendix I).
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study registration.
Patients must not have received the therapies indicated below after disease evaluation or within the specified time period prior to registration on this study as follows:
Hematologic Function:
Renal Function Patients must have adequate renal function defined as age-adjusted serum creatinine ≤1.5 ULN for age
Liver Function
Cardiac Function
Pulmonary Function No evidence of dyspnea at rest
Reproductive Function All females ≥ Tanner stage 2 and post-menarchal of childbearing potential must have a negative beta-HCG within 7 days prior to study registration. Males and females of reproductive age and childbearing potential must commit to using effective contraception for the duration of their participation.
Central Nervous System (CNS) Patients with a history of intraparenchymal or leptomeningeal based CNS disease must have no clinical or radiological evidence of active CNS disease at the time of study enrollment.

Exclusion

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.
Patients with an active or uncontrolled infection. Patients on prolonged antifungal therapy are still eligible if they are culture negative, afebrile, and meet other organ function criteria.
Patients with known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. Testing is not required in the absence of clinical findings or suspicion.
Patients must not have been diagnosed with any other malignancy.
Patients with history of Grade 4 Allergic reactions to anti-GD2 antibody therapy or reactions that caused permanent discontinuation of therapy.
Patients with history of progressive disease while receiving therapy per ANBL1221.
Patient declines participation in the NANT biology study and the site has not been granted a waiver from participation.
Systemic Steroids and Immunosuppressive Medications
Patients who have received pharmacologic doses of systemic steroids 7 days prior to study registration or likely to require them after study registration.
Patients on any other immunosuppressive medications (e.g., cyclosporine, tacrolimus) at the time of study registration.

What this trial measures

  • Best Overall Response Rate of Evaluable PatientsBaseline assessments from within 28 days before Day 1 on study and between days 12-24 of cycles 2, 4, and 6, and within two weeks after the last date of protocol therapy. Each cycle will be 21 days but may be extended to 28 days due to treatment delays.

    The response evaluation is based on central review or site review (when central review is not available) of patient diagnostic assessments. Response is determined by the NANT response criteria v2.0 (https://doi.org/10.1002/pbc.26940). 1. Complete response 2. Partial response 3. Minor response 4. Stable response 5. Progressive disease 6. Early death from malignant disease 7. Early death from toxicity Evaluable response patients have received sufficient therapy (1) and have sufficient response evaluation data to assess best overall response (2) including patients in categories f and g 1. is defined as at least 75% of all therapeutic agents in course 1, or less than 75% in course 1 due to clinical signs of tumor progression or therapy related toxicity. 2. is defined as presence of a disease evaluation for each of the 3 disease parameters (bone, soft tissue, bone marrow) at one or more timepoints after enrollment. Best Overall Response Rate = (a+b+c)/ (a+b+c+d+e+f+g).