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The goal of this study is to demonstrate that cytokine-induced memory-like natural killer cells (CIML-NK cells) can be generated from donor cells and infused safely into patients with relapsed or refractory neuroblastoma during dinutuximab-based therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cytokine-Induced Memory-Like Natural Killer (CIML-NK) Cells | Experimental | The investigational cell product is a cytokine-induced memory-like natural killer cell preparation, derived from the recipient's haploidentical donor's apheresis product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIML-NK Cells | Biological | The investigational cell product is a cytokine-induced memory-like natural killer cell preparation, derived from the recipient's haploidentical donor's apheresis product. At the time of infusion, the product is comprised of:
The concentration and total cell number of CIML-NK cells in the product will vary based on the recipient body weight and the dose requested. |
| Measure | Description | Time Frame |
|---|---|---|
| Infusional Toxicity | Number of subjects who receive an infusion of cytokine-induced memory-like natural killer cells (CIML-NK cells) without grade 3-4 infusional toxicity events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 divided by the number of patients enrolled. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response or Disease Stability to Study Treatment | Number of subjects who demonstrate clinical response to study treatment assessed by modified International Neuroblastoma Response Criteria. | end of cycle 2 (approximately study day 56) |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence of Cytokine-induced Memory-like Natural Killer (CIML-NK) cells in the Recipient's Peripheral Blood | Number of subjects who have persistence of CIML-NK cells in the recipient's peripheral blood, assessed via short tandem repeats assays | 14 days |
Inclusion Criteria:
Age 1-39 years at the time of study enrollment
With diagnosis of neuroblastoma with histologic verification
Classified as high-risk neuroblastoma as defined by Children's Oncology Group (COG) risk classification, including patients initially classified as low or intermediate risk at diagnosis with subsequent reclassification as high-risk disease
With relapsed or refractory disease, including at least one of the following:
Patients must have evaluable disease documented within four weeks of study enrollment. Evaluable disease must include at least one of the following:
With performance level of >50% on Lansky (<16 years) or Karnofsky (>16 years) scales. Patients who are wheelchair bound due to paralysis will be considered ambulatory when assessing their performance score.
Adequate baseline cardiac and pulmonary function including a left ventricular ejection fraction (LVEF) >50% by echocardiogram and pulse oximetry >92% on room air documented within four weeks of study enrollment.
Adequate baseline hematologic function: peripheral absolute neutrophil count (ANC) ≥500/µL, with no receipt of long-acting myeloid growth factors within 14 days or short-acting myeloid growth factors within 7 days of study entry, and a platelet count ≥50,000/µL, with patients required to be transfusion independent for at least 7 days, unless cytopenias are related to marrow metastasis as defined above.
With available haploidentical related donors.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caitlin Cottrell, BSN, RN | Contact | 513-803-7039 | Caitlin.cottrell@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Dandoy, MD, MS | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |