A Phase I/II Study of T Cells Armed with the Bispecific Antibody GD2Bi in Children and Young Adults with Neuroblastoma and Other GD2-Positive Tumors

Full Title

Treatment of Neuroblastoma and GD2-Positive Tumors with Activated T Cells Armed with OKT3 X Humanized 3F8 Bispecific Antibodies (GD2B1): A Phase I/II Study (2013-171)

Purpose

The purpose of this study is to evaluate the safety and preliminary effectiveness of an investigational immunotherapy in children and young adults with neuroblastoma and other tumors that express a protein called GD2. The treatment includes T cells armed with an antibody. The antibody is a "bispecific" antibody, meaning it has two parts. One part is called Hu3F8, which has been used before in children with neuroblastoma and binds to the GD2 protein on cancer cells. The second part of the antibody is called OKT3, which attracts white blood cells called T cells to help kill the cancer cells.

Patients in this study will have some T cells removed from their blood and modified in a laboratory to "coat" them with the bispecific antibody. When the T cells are given back to the patient, they will be better able to find, attach to, and kill cancer cells. Patients will also receive interleukin-2 and GM-CSF, two drugs used to boost the immune system. It is hoped that this treatment will be an effective therapy for neuroblastoma and GD2-positive tumors and have fewer side effects than treatment with chemotherapy or radiation therapy. The treatment is given intravenously (by vein).

Eligibility

  • Patients must have neuroblastoma or another GD2-positive tumor that has continued growing despite therapy or cannot be successfully treated with standard therapies.
  • Patients should recover from the serious side effects of prior therapies before entering the study.
  • This study is for patients older than 1 year and younger than 30.

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

Protocol

15-206

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Diseases

Locations