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.
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
Recurrent disease at any time after completion of frontline therapy
Infectious disease: Active, uncontrolled infection or received a live vaccine within 30 days prior to study enrollment.
Cardiac function: LVEF <50% by echocardiogram, serious uncontrolled cardiac arrhythmias, or history of myocarditis or congestive heart failure (New York Heart Association Functional Classification III or IV)
Pulmonary function: Active interstitial lung disease (ILD)/pneumonitis or history of ILD/pneumonitis requiring systemic corticosteroid treatment.
Renal function: Glomerular Function Rate (GFR) <50 mL/min/1.73 m2 as measured by cystatin C or NM GFR
Single group
CIML-NK Cells
Biological/VaccineThe 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: * Cytokine-Induced Memory-Like NK cells (CIML-NK cells) * Human Serum Albumin * Plasmalyte 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.
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.
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.
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
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