3RD GENERATION GD2 SPECIFIC CHIMERIC ANTIGEN RECEPTOR TRANSDUCED AUTOLOGOUS NATURAL KILLER T-CELLS FOR NEUROBLASTOMA
Status:
Withdrawn
Trial end date:
2030-10-01
Target enrollment:
Participant gender:
Summary
This research study is for patients that have a cancer called Neuroblastoma that has either
come back after treatment or did not respond to the standard medicines used to treat it. This
study combines two different ways of fighting cancer: antibodies and Natural Killer 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. The 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, the investigators made a gene
called a chimeric antigen receptor (CAR), from an antibody called 14g2a that recognizes GD2,
a molecule found on almost all neuroblastoma cells (GD2-CAR). They put this gene into the
patients' own T cells and gave them back to patients that had neuroblastoma. Nineteen
patients were treated on that study and there were no long term side-effects seen after the
GD2 T cell infusion. As the investigators have followed the patients over time, they noticed
that for those patients with disease at the time of their infusion, the time to progression
(the amount of time it takes before their neuroblastoma got worse) was longer in those whom
they could find GD2 T cells in the blood for more than 6 weeks after the last T cell
infusion. Because of this, the investigators think that if effector cells are able to last
longer, they may have a better chance of killing neuroblastoma tumor cells.
Natural Killer T cells are a special subset of innate lymphocytes that can effectively go
into tumor tissues of neuroblastoma. Inside the tumor, there are certain white blood cells
which help the cancer cells to grow and recover from injury. Natural Killer T-cells can
specifically kill these cells. In this study, Natural Killer T cells will be genetically
engineered to express GD2-CAR to attack neuroblastoma cells and the white blood cells inside
the tumor tissue.
Phase:
Phase 1
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
Alex's Lemonade Stand Foundation Center for Cell and Gene Therapy, Baylor College of Medicine Texas Children's Hospital