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
Hucks, George
Protocol No.
LCCC1743-ATL
Description
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.
Disease Sites
Brain and Nervous System
Drugs Involved
AP1903
iC9.GD2.CAR.IL-15
Phase
Phase I
Contact Info
Email for more information
Or Call 877-668-0683
Participating Sites
UNC Hillsborough
UNC-CH
ClinicialTrials.gov
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