GD2 Specific CAR and Interleukin-15 Expressing Autologous NKT Cells to Treat Children With Neuroblastoma
Status:
Recruiting
Trial end date:
2034-08-10
Target enrollment:
Participant gender:
Summary
This research study combines two different ways of fighting cancer: antibodies and Natural
Killer T cells (NKT). Antibodies are types of proteins that protect the body from infectious
diseases and possibly cancer. T cells, also called T lymphocytes, are special white 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. Investigators have
found from previous research that they can put a new gene into T cells that will make them
recognize cancer cells and kill them. In a previous clinical trial, investigators made
artificial genes called a chimeric antigen receptors (CAR), from an antibody called 14g2a
that recognizes GD2, a molecule found on almost all neuroblastoma cells (GD2-CAR).
Investigators put these genes into the patients' own T cells and gave them back to patients
that had neuroblastoma.
NKT cells are another special subgroup of white blood cells that can specifically go into
tumor tissue of neuroblastoma. Inside the tumor, there are other white blood cells called
macrophages which help the cancer cells to grow and recover from injury. NKT cells can
specifically kill these macrophages and slow the tumor growth.
We will expand NKT cells and add GD2-specific chimeric antigen receptors to the cells. We
think these cells might be better able to attack NB since they also work by destroying the
macrophages that allows the tumor to grow. The chimeric antigen receptor will also contain a
gene segment to make the NKT cells last longer. This gene segment is called CD28. In
addition, to further improve the antitumor activity of the GINAKIT cells we added another
gene expressing a molecule called Interleukin -15 (IL-15). The combination of these 3
components showed the most antitumor activity by CAR expressing NKT cells and improved these
cells' survival in animal models.
GD2-CAR expressing NKTs have not been tested in patients so far. The purpose of this study is
to find the largest effective and safe dose of GD2-CAR NKT cells (GINAKIT cells), to evaluate
their effect on the tumor and how long they can be detected in the patient's blood and what
affect they have on the patient's neuroblastoma.
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