C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B)
Status:
Recruiting
Trial end date:
2038-02-01
Target enrollment:
Participant gender:
Summary
This study is for patients with high grade glioma (HGG) or diffuse intrinsic pontine glioma
(DIPG) or medulloblastoma or another rare brain cancer that expresses GD2. Because there is
no standard treatment 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 help 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 cancer patients.
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 study for neuroblastoma in children, 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 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 studies using T cells some researchers 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 brain
cancer.
Phase:
Phase 1
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
Center for Cell and Gene Therapy, Baylor College of Medicine Texas Children's Hospital