Immune cell combo shows promise for tough childhood cancers
NCT ID NCT05400603
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing whether giving children with advanced neuroblastoma or osteosarcoma a special type of immune cell (gamma delta T cells) from a healthy donor, along with several standard cancer drugs, is safe and tolerable. The study will enroll 24 children aged 1 and older whose cancer has not responded to or has returned after previous treatments. The main goal is to find the best dose of the immune cells to use in future studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gamma delta T cells (immune cells from a healthy donor) plus dinutuximab, temozolomide, irinotecan, and zoledronate
- What this could lead to
- If it works, this could offer a new treatment option for children with neuroblastoma or osteosarcoma that has not responded to standard therapy.
- What could go wrong
- This is a very early, small phase 1 trial focused on finding a safe dose, not on proving effectiveness. The combination therapy may cause serious side effects, and the immune cells might not work as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 months and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must be ≥ 12 months of age at the time of enrollment in the study. * Diagnosis: Histological confirmation of neuroblastoma or ganglioneuroblastoma at initial diagnosis. (Bone marrow samples with positive catecholamines are acceptable as confirmation of neuroblastoma) OR histological confirmation of osteosarcoma at diagnosis * Response to prior therapy: * High-risk neuroblastoma with refractory, relapsed or progressive disease, defined as: * First or greater relapse of neuroblastoma following completion of aggressive multi- drug frontline therapy. * First episode of progressive neuroblastoma during aggressive multi-drug frontline therapy. * Persistent/refractory neuroblastoma as defined by less than a complete response by the revised International Neuroblastoma Response Criteria (INRC) after at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol (such as A3973 or ANBL0532). * Note that this excludes patients initially considered low or intermediate-risk neuroblastoma that progressed to high-risk disease but the patient has not progressed after the diagnosis of high-risk neuroblastoma. * Relapsed or refractory osteosarcoma that is not responsive to standard treatment * Disease Status * Patients must have measurable or evaluable disease per revised INRC for subjects with neuroblastoma or measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for subjects with Osteosarcoma * Performance Level:Patients must have a Lansky (≤16 years) or Karnofsky (\>16 years) score of ≥50 * Prior Therapy * Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy before study registration. * Prior dinutuximab therapy is allowed regardless of prior response or progression on dinutuximab * Prior temozolomide therapy is allowed * Prior zoledronate is allowed * Prior dinutuximab/temozolomide/irinotecan chemoimmunotherapy is allowed * Prior T cell therapy is excluded * Organ Function Requirements: * Hematologic Functions : Absolute Neutrofil count ≥750/uL and platelet count ≥ 75,000/µl, transfusion independent . * Renal Function: Patients must have adequate renal function defined as age-adjusted serum creatinine ≤1.5 ULN for age. * Liver Function: Total bilirubin ≤ 1.5 x ULN for age and serum glutamic-pyruvic transaminase (SGPT) (ALT) ≤ 135 U/L (≤ 3x ULN). * Cardiac Function: Normal ejection fraction (≥ 55%) documented by either echocardiogram or radionuclide multigated acquisition scan (MUGA) evaluation OR Normal fractional shortening (≥ 27%) documented by echocardiogram * Pulmonary Function: Normal pulmonary function with no evidence of dyspnea at rest, no exercise intolerance. Exclusion Criteria: * Prior T cell therapy * Pregnancy, breast feeding, or unwillingness to use effective contraception during the study will not be entered on this 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 known active Central Nervous System (CNS) disease (excluding skull disease with intracranial extension). Patients with a history of CNS disease are required to have a brain CT and/ or MRI at study registration. * Patients with prior allogeneic stem cell 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 * 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 with disease of any major organ system that would compromise their ability to withstand therapy. * Patients who have had to permanently discontinue Dinutuximab due to toxicity * Patients with serious, uncontrolled cardiac arrhythmias * Patients with a history of myocarditis * Patients who have received any live vaccines within 30 days before enrollment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Healthcare of Atlanta
RECRUITINGAtlanta, Georgia, 30322, United States
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