A Phase I Study of Autologous Activated T-Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch Administered To Patients With Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma
UNC Lineberger Comprehensive Cancer Center
Summary
The body has different ways of fighting infections and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are molecules that fight infections and protect your body from diseases caused by bacteria and toxic substances. Antibodies work by sticking to those bacteria or substances, which stops them from growing and causing bad effects. T cells are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected. Both antibodies and T cells have been used to treat patients with cancers. They both have shown promise, but neither alone has been enough to cure most patients. This multicenter study is designed to combine both T cells and antibodies in order to create a more effective treatment. The treatment that is being researched is called autologous T lymphocyte chimeric antigen receptor cells (CAR) cells targeted against the disialoganglioside (GD2) antigen that express Interleukin (IL)-15, and the inducible caspase 9 safety switch (iC9), also known as iC9.GD2.CAR.IL-15 T cells.
Description
In previous studies, it has been shown that when T cells have part of an antibody attached to them, they are better at recognizing and killing cancer cells. The antibody that will be used in this study is called anti-GD2. This antibody floats around in the blood and can detect and stick to cancer cells called neuroblastoma cells because they have a substance on the outside of the cells called GD2. For this study, the anti-GD2 antibody has been changed so that instead of floating freely in the blood, it is now joined to the T cells. However, it is unknown how long the iC9.GD2.CAR.IL-15 T cells…
Eligibility
- Age range
- 1+ years
- Sex
- All
- Healthy volunteers
- No
All clinical and laboratory data required for determining eligibility must be available in the subject's medical/research record which will serve as the source document. Because of the nature of iC9.GD2.CAR.IL-15 T cell product preparation, subjects will be assessed for initial study enrollment eligibility (prior to cell procurement) and then will have to meet criteria prior to starting lymphodepletion and prior to T cell infusion. Inclusion Criteria for the Study: 1. Written HIPAA authorization signed by legal guardian. 2. Adequate performance status as defined by Lansky or Karnofsky perfo…
Interventions
- BiologicaliC9.GD2.CAR.IL-15 T-cells
Three dose levels are being evaluated: 0.5 x 10\^6, 1.0 x 10\^6, 1.5 x 10\^6
- DrugCyclophosphamide
500 mg/m\^2 IV dose on days 1-2 for lymphodepletion prior to cell infusion
- DrugFludarabine
30 mg/m\^2 IV dose on days 1-4 for lymphodepletion prior to cell infusion
Locations (2)
- Emory - Winship Cancer InstituteAtlanta, Georgia
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina