15.GPC3-CAR T cells

Four different dosing schedules will be evaluated. The following dose levels will be evaluated: DL1: 5x10^6 DL2: 1x10^7 DL3: 5x10^7 DL4: 1x10^8

The study team will collect up to 180 mL (approximately 12 tablespoons) of participants blood. This will be used to grow T cells. The study team grows the T cells and uses a retrovirus (a special virus that can insert the GPC3 CAR and IL15 genes into the T cells) to genetically engineer them. After the CAR and IL15 genes were put into the T cells, the study team ensures that they could kill GPC3 positive solid tumor cells in the laboratory.

WHAT THE TREATMENT WILL BE LIKE: After making these cells, they were frozen. If the participant agrees to participate in this study, at the time they are scheduled to be treated, the cells will then be thawed and administered in the participants tumor area, called an intracavitary or intracerebroventricular administration, during the participants already scheduled surgical resection. The participant will only get one dose of GO-CART T cells.

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.

Registro actualizado en ClinicalTrials.gov →

• Diagnosis of GPC3-positive recurrent glioblastoma with previous resection planned for repeat resection (as determined by immunohistochemistry).
• Karnofsky score ≥60%
• Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.