AUTOLOGOUS ACTIVATED T-CELLS TRANSDUCED WITH A 3rd GENERATION GD-2 CHIMERIC ANTIGEN RECEPTOR AND iCASPASE9 SAFETY SWITCH ADMINISTERED TO PATIENTS WITH RELAPSED OR REFRACTORY NEUROBLASTOMA (GRAIN)
We will make iC9-GD2 T cells by infecting normal T cells with a retroviral vector containing
the iC9-GD2 gene. After the new gene has been put into the T cells, the cells will be tested
to make sure that they kill GD2-positive neuroblastoma cells and then frozen until the
patient is ready for their infusion.
The infusion will be given by the Center for Cell and Gene Therapy at Texas Children's
Hospital in Houston, Texas. The injection will take between 5 and 10 minutes, but patients
should expect to remain in Houston for the first few weeks after the infusion just in case
we need to give AP1903 to turn on the safety switch within the cells.
There will be follow-up visits every 1-2 weeks during the first 2 months and then they will
be spaced out over a total of 15 years. Because the cells are modified with a new gene we
must follow patients for at least 15 years to see if there are any long term side effects of
gene transfer. During the visits, we will see how the patients are doing and during certain
time points we will obtain extra blood samples to learn more about the way the iC9-GD2 T
cells are working and how long they last in the body.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose limiting toxicities at 6 weeks post T cell infusion
We will measure and assess the adverse events to find the maximum tolerated dose of iC9-GD2 T cells and the safety profile of iC9-GD2 T cells.
6 weeks after infusion of the last dose of iC9-GD2 T cells to all patients on the study
Chrystal Louis, MD
Baylor College of Medicine
United States: Food and Drug Administration
|Texas Children's Hospital||Houston, Texas|