GINAKIT Cells

Six dose levels of GINAKIT cells will be studied. Dosing will be based on the actual number of transduced cells. All doses are per m2. * Dose Level 1 = 3 x 10\^6 * Dose Level 2 = 1 x 10\^7 * Dose Level 3 = 3 x 10\^7 * Dose Level 4 = 1 x 10\^8 * Dose Level 5 = 3 x 10\^8 * Dose Level 6 = 1 x 10\^9

Four dose levels of GINAKIT cells in combination of Etanercept will be studied. Dosing will be based on the actual number of transduced cells. All doses are per m2. * Combination Dose level 1: 3 x 10\^6 + Etanercept\* * Combination Dose level 2: 1 x 10\^7 + Etanercept\* * Combination Dose level 3: 3 x 10\^7 + Etanercept\* * Combination Dose level 4: 1 x 10\^8 + Etanercept

In this study the first step is to collect blood from the patient to make the GINAKIT cells. Once the GINAKIT cells are made they will be administered to the patient. Patients will be treated on a single fixed dose level with Etanercept from now on. If there is severe toxicity related to the combination of GINAKIT cells and Etanercept, we will treat patients on lower dose level.

This research study combines two different ways of fighting cancer: antibodies and Natural Killer T cells (NKT). Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special white blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers.

Investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them. In a previous clinical trial, investigators made artificial genes called a chimeric antigen receptors (CAR), from an antibody called 14g2a that recognizes GD2, a molecule found on almost all neuroblastoma cells (GD2-CAR).

Live record on ClinicalTrials.gov →

• Procurement Inclusion Criteria:
• Relapsed or refractory high risk neuroblastoma
• Life expectancy of at least 12 weeks
• Age greater than 1 year and less than 21 years old
• Karnofsky/Lansky score of 60% or greater
• Absence of HAMA prior to enrollment (only in patients that have been previously treated with murine antibodies)

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.