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Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Relapsed/Refractory Neuroblastoma

This study is testing a new drug, rhIL-15, along with three standard cancer drugs (dinutuximab, irinotecan, and temozolomide) for children and young adults with neuroblastoma. Neuroblastoma is a type of cancer that affects nerves, mainly in infants and toddlers. This trial is for those whose neuroblastoma has come back or didn't respond to previous treatments. The main goal is to find out if this combination of drugs is safe and to determine the best dose of rhIL-15. This study focuses on how the immune system responds to cancer (immunotherapy). You can join if you are between 3 and 35 years old and have a confirmed diagnosis of neuroblastoma.

Study design
This is a Phase I study, meaning it's an early-stage trial to assess safety and dosage. It plans to enroll 40 participants.
What's involved
You will have a physical exam, blood and urine tests, imaging scans, heart and lung tests, and a bone marrow biopsy. Treatment will be given in 21-day cycles, and you may have up to 4 cycles.
Compensation
Not stated in the trial record.
Follow-up
The primary safety and dosage assessments will be measured at 6 weeks after treatment begins.

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

NCT06995872

Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma

Recruiting
PHASE1Ages 3–35InterventionalTreatment
National Cancer Institute (NCI)
~40 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:rhIL-15DinituximabTemozolomideIrinotecan Hydrochloride

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess the safety and determine the MTD of rhIL-15 combined with dinutuximab/temozolomide/irinotecan
Measured over 6 weeks

Conditions

Neuroblastoma

Explore related trials

Neuroblastoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Hong Ha Rosa Nguyen, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Hong Ha Rosa Nguyen, M.D.
[email protected]
(443) 902-3243
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Presence of pericardial effusion.
Chronic immunosuppression (physiologic steroid supplementation is allowed but any chronic immunosuppressant like steroids or other modulators are not allowed)
Major surgery within 4 weeks prior to initiation of study therapy
Current/active human immunodeficiency virus (HIV) infection, as measured by seropositivity for HIV antibody.
Current/active HBV/HCV infection as measured by seropositivity for Hepatitis C or positive for Hepatitis B surface antigen (HBsAg).
History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biological composition to irinotecan and temozolomide used in study.
Participants with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.
Positive serum or urine beta-HCG pregnancy test performed at screening due to the teratogenic effects of chemotherapy.
Participants with a prior or concurrent malignancy whose natural history or treatment with the safety or efficacy assessment of the investigational regimen.
Participants with \>= grade 2 diarrhea at the time of entry.
Participants who are unable to tolerate oral/nasogastric/gastrostomy medications. Additionally, participants with significant malabsorption will not be eligible for this trial.
Participants with uncontrolled infection.
Participants with a history of Grade 4 allergic reactions to anti-GD2 antibodies or reactions that required permanent discontinuation of the anti-GD2 therapy.

What this trial measures

  • Assess the safety and determine the MTD of rhIL-15 combined with dinutuximab/temozolomide/irinotecan6 weeks

    Assessment of AEs and DLTs in participants.