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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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: * 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.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITINGInfusional 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.
Time frame: 30 days
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.
Time frame: end of cycle 2 (approximately study day 56)
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