Phase I study for the treatment of patients with GD2-expressing brain tumors (GAIL B) (H-45668)
Phase I study of autologous T lymphocytes expressing GD2-specific chimeric antigen and constitutively active IL-7 receptors for the treatment of patients with GD2-expressing brain tumors (GAIL-B)
This study is for patients with high grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG). Because there is no standard treatment for this cancer at this time, patients are being asked to volunteer in a gene transfer research study using special immune cells called T cells. T cells are a type of white blood cell that helps the body fight infection.
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients.
We have found from previous research that we can put a new antibody gene into T cells that will make them recognize cancer cells and kill them. GD2 is a protein found on several different cancers. When we and other researchers tested DIPG/HGG cancer cells we found that many of these cancers also have GD2 on their surface.
In a clinical trial for a different cancer in children (neuroblastoma), we made a gene called a chimeric antigen receptor (CAR) from an antibody that recognizes GD2. We put this gene into the patients' own T cells and gave them back to 11 neuroblastoma patients. We saw that the cells did grow for a while, but started to disappear from the blood after 2 weeks. We think that if T cells are able to last longer, they may have a better chance of killing tumor cells.
In this study we will add a new gene to the GD2 T cells that can cause the cells to live longer. We know that T cells need substances called cytokines to survive. We have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time.
In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and we think that it will allow the T cells to expand and stay longer in the body, and potentially kill cancer cells more effectively.
The GD2.C7R T cells are an investigational product not approved by the Food and Drug Administration.
The purpose of this study is to find the largest safe dose of GD2-C7R T cells, and also to evaluate how long they can be detected in the blood and what affect they have on DIPG/HGG.
AGE REQUIREMENTS: 12 Months to 21 Years (Child, Adult)
More information about this study can be found online.
NCT#/ClinicalTrials.gov ID: NCT04099797