Interleukin-15 Armored Glypican 3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors
Status:
Recruiting
Trial end date:
2040-01-01
Target enrollment:
Participant gender:
Summary
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 AGAR 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 (a tiny part of
what makes-up DNA and carries your traits) into T cells that will make them recognize cancer
cells and kill them. In the lab, investigators made several genes called a chimeric antigen
receptor (CAR), from an antibody called GPC3. The antibody GPC3 recognizes a protein found
solid tumors including pediatric liver cancers. This CAR is called GPC3-CAR. To make this CAR
more effective, investigators also added a gene that includes IL15. IL15 is a protein that
helps CAR T cells grow better and stay in the blood longer so that they may kill tumors
better. The mixture of GPC3-CAR and IL15 killed tumor cells better in the laboratory when
compared with CAR T cells that did not have IL15 .This study will test T cells that
investigators made (called genetic engineering) with GPC3-CAR and the IL15 (AGAR T cells) in
patients with GPC3-positive solid tumors such as yours.
T cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug
called AP1903. The investigators will insert the iCasp9 and IL15 together into the T cells
using a virus that has been made for this study. The drug (AP1903) is an experimental drug
that has been tested in humans with no bad side-effects. The investigators will use this drug
to kill the T cells if necessary due to side effects.
This study will test T cells genetically engineered with a GPC3-CAR and IL15 (AGAR T cells)
in patients with GPC3-positive solid tumors.
The AGAR 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 AGAR 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 AGAR T
cells will help people with GPC3-positive solid tumors.
Phase:
Phase 1
Details
Lead Sponsor:
Baylor College of Medicine
Collaborator:
Center for Cell and Gene Therapy, Baylor College of Medicine