A Phase I Study of Hu3F8 with Donated Natural Killer Cells to Treat Recurrent or Persistent Neuroblastoma

Full Title

Phase I Study of the Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma

Purpose

3F8 is an antibody that attaches to neuroblastoma cells and helps focus a patient's own immune system -- especially white blood cells -- to attack neuroblastoma cells. Conventional 3F8 is made from mouse cells. Hu3F8 is made to be more like the human immune system than a mouse's immune system, so it may be associated with fewer side effects in patients than mouse-derived 3F8. Natural killer (NK) cells are white blood cells that recognize and kill abnormal cells in the body and can work together with antibodies like Hu3F8 to kill target cells (in this case, neuroblastoma cells).

In this study, researchers are evaluating the safety of a new treatment for patients with neuroblastoma that has not responded to standard treatment or came back after prior therapy. This new treatment includes Hu3F8, the anticancer drug cyclophosphamide, and natural killer (NK) cells from a mismatched donor. Patients will also receive a treatment called interleukin-2 (IL-2), which stimulates NK cells to grow and survive. All treatments in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have neuroblastoma that has not responded to standard treatment or came back after prior therapy.
  • This study is for both children and adults.

For more information about this study and to inquire about eligibility, please contact Dr. Shakeel Modak at 212-639-7623.

Protocol

15-272

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases

Locations