GPC3-CAR T Cells for Brain Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Baylor College of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?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 participants with cancers. They have shown promise, but have not been strong enough to cure most participants. The study team has found from previous research that we can put a new gene (a tiny part of what makes-up DNA and carries the participants traits) into T cells that will make them recognize cancer cells and kill them. In the lab, the study team has made several genes called a chimeric antigen receptor (CAR), from an antibody called GC33. The antibody GC33 recognizes a protein found on the participants brain tumor. This CAR is called GPC3-CAR. To make this CAR more effective, the study has 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 with the IL15 GPC3-CAR (GO-CART T cells) in participants with GPC3-positive brain tumors. T cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called AP1903. The study team 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 study team 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 (GO-CART T cells) in participants with GPC3-positive brain tumors. The GO-CART T cells are an investigational product not approved by the Food and Drug Administration.

Eligibility Criteria

This trial is for individuals with recurrent GPC-3 positive glioblastoma, a type of brain cancer. Participants must have tumors that express the GPC-3 protein to be eligible. Specific inclusion and exclusion criteria details are not provided but would typically include factors like age, health status, prior treatments, and other medical conditions.

Inclusion Criteria

I can care for myself but may need occasional help.

Procurement: Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent

I have had surgery for recurrent glioblastoma.

+10 more

Exclusion Criteria

Procurement: History of organ transplantation

Procurement: Known HIV positivity

I am HIV positive.

+7 more

Participant Groups

The trial is testing genetically engineered T cells called GO-CART T cells. These cells have been modified with a new gene to recognize and kill cancer cells by targeting the GPC-3 protein on brain tumors. The study also uses IL15 to help these CAR T cells grow better and an iCasp9 gene allowing controlled cell death if needed.

1Treatment groups

Experimental Treatment

Group I: 15.GPC3-CAR T cellsExperimental Treatment1 Intervention

GPC3-CAR and IL15 will be administered to patients with GPC3-positive glioblastoma.