Glypican 3-specific Chimeric Antigen Receptor Expressed in T Cells for Patients With Pediatric Solid Tumors (GAP)
Status:
Recruiting
Trial end date:
2037-02-01
Target enrollment:
Participant gender:
Summary
This study enrolls patients who have GPC3-positive solid tumors currently. Patients may be
considered if the cancer has come back, has not gone away after standard treatment or the
patient cannot receive standard treatment. This research study uses special immune system
cells called GAP T cells, a new experimental treatment.
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 they can put a new gene into T cells
that will make them recognize cancer cells and kill them. In preclinical studies, the
investigators made several genes called a chimeric antigen receptor (CAR), from an antibody
called GC33 that recognizes glypican-3, a proteoglycan found on solid tumors including
pediatric liver cancers (GPC3-CAR). This study will test T cells genetically engineered with
a GPC3-CAR (GAP T cells) in patients with GPC3-positive solid tumors (currently only
enrolling liver tumors).
The GAP T cells are an investigational product not approved by the Food and Drug
Administration.
The purpose of this study is to find the biggest dose of GAP T cells that is safe, to see how
long they last in the body, to learn what the side effects are and to see if the GAP T cells
will help people with GPC3-positive solid tumors. This study enrolls patients who have
GPC3-positive solid tumors (currently only enrolling liver tumors).
Phase:
Phase 1
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
Cancer Prevention Research Institute of Texas Center for Cell and Gene Therapy, Baylor College of Medicine Cookies for Kids' Cancer Curing Kids' Cancer Foundation Texas Children's Hospital The V Foundation