Double immune attack: new cell combo targets tough childhood cancers
NCT ID NCT07211737
First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 4 times
Summary
This early-phase study tests a new combination of two different immune cells—NK cells and CAR-T cells—for children and young adults with neuroblastoma or osteosarcoma that has returned or not responded to standard treatments. The NK cells are designed to help the CAR-T cells work better in the tumor environment. The main goals are to find the safest dose and see if the treatment can shrink tumors. About 27 participants will be enrolled.
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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 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Apr 2044
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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1 year to 24 years
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
PROCUREMENT INCLUSION: 1. Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed/refractory disease. Or Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed/refractory disease. 2. Karnofsky/Lansky score of 60% or greater. 3. Informed consent and assent (as applicable) obtained from parent/guardian and child. 4. Greater than 1 year of age. PROCUREMENT EXCLUSION: 1. History of hypersensitivity to murine protein-containing products. 2. Known presence of Human Anti-Mouse Antibodies (HAMA). 3. Active autoimmune disease (requiring immunosuppressive treatment in the past 6 months). 4. Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required). TREATMENT INCLUSION: 1. Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed/refractory disease. Or Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed/refractory disease. 2. Karnofsky/Lansky score of 50% or greater 3. Pulse Ox greater than or equal to 90% on room air 4. AST less than 5 times upper limit of normal (less than 10 times upper normal if known with metastatic liver disease) 5. Total bilirubin less than 3 times the upper limit of normal 6. Serum creatinine less than 3 times upper limit of normal 7. Available autologous T-cells with greater than or equal to 20% expressing GD2.CAR 8. Informed consent and assent (as applicable) obtained from parent/guardian and child. 9. Greater than 1 year of age. 10. Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study. TREATMENT EXCLUSION: 1. History of hypersensitivity to murine protein containing products (patients who have undergone desensitization and successful re-challenge without hypersensitivity reaction are eligible). 2. Known presence of Human Anti-Mouse Antibodies (HAMA). 3. Tumor potentially causing airway obstruction per investigator discretion. 4. Pregnancy or lactation / will not use birth control methods. 5. Currently receiving immunosuppressive drugs (patients on low dose corticosteroids are eligible: less than 0.25 mg/kg/day of prednisone/equivalent). 6. Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required).
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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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Texas Children's Hospital
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Slowing down immunotherapy infusion may reduce pain in children with Tough-to-Treat neuroblastoma
- Supercharged immune cells take aim at childhood cancers
- Targeted drug shows promise for kids with tough cancers
- New hope for kids with Hard-to-Treat cancers: targeted drug shows promise