iC9-GD2-CAR-VZV-CTLs/Refractory or Metastatic GD2-positive Sarcoma and Neuroblastoma
Status:
Active, not recruiting
Trial end date:
2034-10-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to find the largest safe dose of GD2-T cells (also called
iC9-GD2-CAR-VZV-CTLs) in combination with a varicella zoster vaccine and lymohodepleting
chemotherapy. Additionally, we will learn what the side effects of this treatment are and to
see whether this therapy might help patients with advanced osteosarcoma and neuroblastoma.
Because there is no standard treatment for recurrent/refractory osteosarcoma and
neuroblastoma at this time or because the currently used treatments do not work fully in all
cases, patients are being asked to volunteer to take part in a gene transfer research study
using special immune cells.
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. Antibodies are types of proteins that protect the body from
infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special
infection-fighting blood cells that can kill other cells, including cells infected with
viruses and tumor 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.
Investigators have found from previous research that a new gene can be put into T cells that
will make them recognize cancer cells and kill them. Investigators now want to see if a new
gene can be put in these cells that will let the T cells recognize and kill sarcoma and
neuroblastoma cells. The new gene is called a chimeric antigen receptor (CAR) and consists of
an antibody called 14g2a that recognizes GD2, a protein that is found on sarcoma and
neuroblastoma cells (GD2-CAR). In addition, it contains parts of the CD28 and OX40 genes
which can stimulate T cells to make them live longer.
Investigators have found that CAR-T cells can kill some of the tumor, but they don't last
very long in the body and so the tumor eventually comes back. T cells that recognize the
virus that causes chicken pox, varicella zoster virus (VZV), remain in the bloodstream for
many years especially if they are stimulated or boosted by the VZV vaccine. Investigators
will therefore insert the GD2-CAR gene into T cells that recognize VZV. These cells are
called iC9-GD2-CAR-VZV-specific T cells but are referred to as GD2-T cells for simplicity.
Phase:
Phase 1
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
Center for Cell and Gene Therapy, Baylor College of Medicine National Cancer Institute (NCI) The Methodist Hospital Research Institute