Study on Using Donor Memory-Like Natural Killer Cells for Treating Relapsed or Hard-to-Treat Neuroblastoma
Sponsor: Children's Hospital Medical Center, Cincinnati
ClinicalTrials ID:NCT07635056
This clinical trial is exploring a new treatment using special immune cells from a donor to help fight neuroblastoma that has returned or is not responding to standard treatments. The study aims to see if these cells can be safely given to patients during therapy with the drug dinutuximab.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to test if a new type of immune cell treatment, called cytokine-induced memory-like natural killer cells (CIML-NK), can be safely used in patients with neuroblastoma that has come back or is not responding to treatment. These cells are taken from a donor and given to the patient alongside a drug called dinutuximab to see if they can help control the cancer.
Eligibility Criteria
Inclusion Criteria
- Aged between 1 and 39 years old.
- Diagnosed with neuroblastoma, confirmed by lab tests.
- Classified as high-risk neuroblastoma, even if initially considered low or intermediate risk but later reclassified.
- Cancer has returned or is not responding to treatment, including:
- Cancer came back after finishing initial treatment.
- Cancer is getting worse after starting standard treatment.
- Cancer did not fully respond after at least four cycles of standard chemotherapy.
- Must have cancer that can be measured or detected by scans or tests within four weeks before joining the study.
- Must be in good enough health to participate, with a performance score above 50%.
- Must have good heart and lung function, with specific test results showing adequate levels.
- Must have good blood cell counts and not need recent blood transfusions, unless due to cancer in the bone marrow.
- Must have a suitable donor who is a close relative.
Exclusion Criteria
- Have an active, uncontrolled infection or received a live vaccine within 30 days before joining the study.
- Have serious heart problems, including low heart function or history of heart failure.
- Have lung disease or history of lung problems needing steroid treatment.
- Have poor kidney function based on specific tests.
- Have severe liver problems, with high bilirubin or liver enzyme levels.
- Taking more than 0.5 mg/kg of prednisone or equivalent daily.
- Have received other experimental treatments within 30 days before the study treatment.
- Have an allergy to IL-2 injections.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | 45229 | Cincinnati | Ohio |
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