|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 or Refractory Neuroblastoma||Principal Investigator
This study is the first time iC9.GD2.CAR.IL-15 cells have been given to humans and the first use of iC9.GD2.CAR.IL-15 T cells in combination with AP1903. AP1903 (also known as rimiducid) is a drug that can be used to turn on (induce) the safety switch on the iC9.GD2.CAR.IL-15 T cells if you have any bad effects, such as pain, that does not respond to normal treatment. The FDA has not yet approved giving iC9.GD2.CAR.IL-15 T cells alone or in combination with AP1903. Also, giving iC9.GD2.CAR.IL-15 T cells with or without lymphodepleting chemotherapy has not yet been approved by the FDA. Additionally, AP1903 is also not a FDA-approved drug alone or in combination with iC9.GD2.CAR.IL-15 T cells. This study will help us identify several unknown facts, including: Determining a dose of iC9.GD2.CAR.IL-15 T cells that does not cause too many bad effects (is safe and tolerable) in patients with neuroblastoma that has come back after or has not responded to previous treatments; Assessing how well the iC9.GD2.CAR.IL-15 T cells grow and survive in the body; Evaluating how neuroblastoma that has come back after or has not responded to previous treatments responds to the iC9.GD2.CAR.IL-15 T cell infusion; and Determining how well the safety switch functions (works) by using AP1903 for patients who experience intense pain that does not respond to normal treatment.
Brain and Nervous System
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