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Relapsed NeuroblastomaPhase 1/2STINGNCT04211675

NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab

A Phase 1/2 study testing Natural Killer Cells, Temozolomide and Irinotecan in people with Relapsed Neuroblastoma and Refractory Neuroblastoma, run by Nationwide Children's Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 29 years
What is being tested?
Natural Killer Cells, Temozolomide and Irinotecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
1 Sep 2022to Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 29 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Less than 30 years of age when registered on the study.
  • Patients must have a histologic verification of neuroblastoma (NBL) or ganglioneuroblastoma or NBL cells in bone marrow with or without elevated urine catecholamines.
  • Life expectancy >2 months, AND one of the following:
  • Recurrent disease; or
  • First episode of progressive disease (new lesion, increase in size, previous negative bone marrow) during initial multi-drug, induction myelosuppressive therapy; or
  • Primary resistant/refractory disease (partial, mixed, stable response criteria met) after completing at least 4 cycles of induction multi-drug induction chemotherapy
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  • One of the following:
  • Patients must have measurable or evaluable tumor defined as: a) Measurable tumor on MRI or CT obtained within 4 weeks prior to study entry; Measurable is defined as ≥ 10mm in at least one dimension AND that has positive uptake on I-123 MIBG scan ("MIBG avid") or demonstrates increased FDG uptake on 18F-FDG PET-CT or PET-MRI ("PET-avid"); OR b) Evaluable tumor by I-123 MIBG scan within 4 weeks prior to study entry, defined as positive uptake at a minimum of one site;
  • Measurable or evaluable disease must represent recurrent disease after therapy completion or progressive disease on therapy or refractory disease during induction;
  • Patients with refractory disease that are not avid on MIBG scan and do not have increased FDG uptake on PET must have biopsy proven viable NBL;
  • New soft tissue sites that are MIBG avid or PET avid do not require biopsy as long as initial histologically-confirmed NBL diagnosis prior to current therapy
  • Patients must have progressed during or following completion of frontline therapy. Agents considered to be a part of frontline therapy would include chemotherapy, radiation therapy, autologous stem cell transplantation, retinoids, immunotherapy with anti GD2 agents, cellular therapies, or I-131 MIBG, and frontline therapy is defined as any combination of these agents defined in published regimens or current cooperative group clinical trials for the successful treatment of that cancer. Therapy may not have been received more recently than the timeframes defined below:
  • Myelosuppressive chemotherapy: At least 14 days since completion of myelosuppressive therapy
  • Biologic: At least 7 days since completion of therapy with non-myelosuppressive biologic or retinoid
  • Radiation: At least 4 weeks since completion of radiation to any site identified as a target lesion. Palliative radiation is allowed to sites not used to measure response
  • Stem Cell Transplant (SCT): At least 6 weeks after autologous stem cell transplant or stem cell infusions as long as hematologic criteria have been met
  • 131I-MIBG Therapy: At least 6 weeks after therapeutic MIBG treatment
  • Cellular therapies: At least 6 weeks after any cellular therapy treatment (e.g., prior NK, CAR-T therapy)
  • Subjects who have previously received anti-GD2 monoclonal antibodies for biologic therapy or for tumor imaging are eligible.
  • Subjects who have received autologous marrow infusions or autologous stem cell infusions that were purged using monoclonal antibody linked to beads are eligible.
  • No treatment with irinotecan and/ or temozolomide within the last 6 months.
  • Adequate bone marrow function, defined as:
  • Peripheral absolute neutrophil count (ANC) ≥500/microL. Patients must not have received long-acting myeloid growth factors (e.g., Neulasta) within 14 days or short-acting myeloid growth factors (e.g., Neupogen) within 7 days of study entry.
  • Platelet count ≥50,000/microL (transfusion independent for at least 1 week)
  • Adequate renal function defined as:
  • Creatinine clearance or estimated radioisotope GFR ≥70 ml/min/1.73m2 or
  • Serum creatinine < 2x upper limit of normal (ULN) based on age/gender
  • Adequate liver function defined as:
  • Total bilirubin <1.5x ULN for age AND
  • SGPT (ALT) ≤5x ULN for age (or ≤225 U/L). For purpose of this study, the ULN for SGPT (ALT) is 45 U/L.
  • Adequate central nervous system function defined as:
  • Patients with seizure disorders may be enrolled if seizures are well controlled on anti-convulsants
  • CNS toxicity ≤ Grade 2
  • Adequate cardiac function defined as:
  • Shortening fraction of ≥ 27% by ECHO OR
  • Ejection fraction ≥ 50% by ECHO or gated radionuclide study
  • Adequate pulmonary function defined as:
  • No evidence of dyspnea at rest, no exercise intolerance, no chronic oxygen requirement, and room air pulse oximetry > 94% if there is a clinical indication for pulse oximetry

Who cannot join

  • Patients who are pregnant or breastfeeding
  • Patients with elevated catecholamines (>2x ULN) only.
  • Patients must not have received 0.5 mg/ kg/ day (prednisone equivalent) doses of systemic steroids for at least 7 days prior to enrollment.
  • Patients must not have received CYP3A4 inducer or inhibitor for at least 7 days prior to study enrollment.
  • Patients must not have been diagnosed with any other malignancy.
  • Patients must not have > Grade 2 diarrhea.
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  • Patients must not have uncontrolled infection.
  • Patients with history of Grade 4 allergic reactions to anti-GD2 antibodies or reactions that required discontinuation of anti-GD2 therapy.
  • Patients with a significant illness that is not covered by the exclusion criteria or that is expected to interfere with the action of study agents or to increase the severity of the toxicities experienced from the study treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

Other trials in United States

About this study

Official title: 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

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.

Being tested
Natural Killer Cells, Temozolomide, Irinotecan, Dinutuximab, Sargramostim
Medical subject headings
Neuroblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Natural Killer CellsBiological

    NK cells dose 1x 108 cells/ kg on day 8 of each cycle

  • TemozolomideDrug

    Also called Temodar

    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.

  • IrinotecanDrug

    Also called Camptosar

    Irinotecan 50mg/m2/dose IV daily on Days 1-5

  • DinutuximabDrug

    Dinutuximab 17.5mg/m2/dose IV daily on Days 2-5

  • SargramostimDrug

    Also called Leukine

    Sargramostim 250mcg/m2/dose subcutaneous daily on Days 6-12

Study groups in NCT04211675
Study groupRoleWhat they receive
TreatmentOtherThe planned therapy will involve 6 cycles of 21 days each consisting of irinotecan, temozolomide, dinutuximab, sargramostim, and natural killer (NK) cells. Treatment cycles will be repeated every 21 days based upon disease response and toxicity criteria. Tumor response will be assessed after Cycles 2, 4 and 6. Patients who do not experience dose-limiting toxicities and achieve complete response, partial response or stable disease may continue to receive the assigned therapy.
Receives: Biological: Natural Killer Cells; Drug: Temozolomide; Drug: Irinotecan; Drug: Dinutuximab; Drug: Sargramostim

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NK cells safety and tolerability: Number of participants with treatment-related adverse events and toxicities

    Number of participants with treatment-related adverse events and toxicities as assessed by CTCAE v4.0

    Measured: 12 months

  2. Response to NK Cell treatment as determine by CT/MRI imaging

    To estimate the response to treatment, as determined by disease status evaluated using CT/MRI scans through the measuring tool RECIST.

    Measured: 24 months

  3. Response to NK Cell treatment as determine by MIBG scans imaging

    To estimate the response to treatment, as determined by disease status evaluated using MIBG scans through the Curie score system.

    Measured: 24 months

  4. Response to NK Cell treatment as determine by bone marrow aspiration

    To estimate the response to treatment, as determined by disease status evaluated using bone marrow aspiration and biopsy through H\&E stain. RECIST.

    Measured: 24 months

Secondary outcomes (1)

  1. Toxicity Definition of NK cells

    Toxicity will be graded using the CTCAE criteria, version 5.0. All grade 3+ toxicities will be reviewed for attribution.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2019
  2. Study start1 Sep 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04211675
Sponsor's protocol ID
STUDY00000476
Acronym
STING
Status last verified
Sep 2026
First submitted
14 Oct 2019
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Natural Killer Cells, Temozolomide and Irinotecan in people with Relapsed Neuroblastoma and Refractory Neuroblastoma, run by Nationwide Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NK cells safety and tolerability: Number of participants with treatment-related adverse events and toxicities (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04211675.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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