drugset / Trial / NCT03334305

Adoptive Cellular Therapy in Pediatric Patients With High-grade Gliomas

NCT03334305

Non-randomizedSequentialOpen-labelTreatment

Summary

It is believed that the body's immune system protects the body by attacking and killing tumor cells. T-lymphocytes (T-cells) are part of the immune system and can attack when they recognize special proteins on the surface of tumors. In most patients with advanced cancer, T-cells are not stimulated enough to kill the tumor. In this research study, we will use a patient's tumor to make a vaccine which we hope will stimulate T-cells to kill tumor cells and leave normal cells alone. High grade gliomas (HGGs) are very aggressive and difficult for the body's immune system to attack. Before T-cells can become active against tumor cells, they require strong stimulation by special "stimulator" cells in the body called Dendritic Cells (DCs) which are also part of the immune system. DCs can recognize the cancer cells and then activate the T lymphocytes, and create this strong stimulation. The purpose of this research study is to learn whether anti-tumor T-cells and anti-tumor DC vaccines can be given safely. Most importantly, this study is also to determine whether the T-cells and DC vaccines can stimulate a person's immune system to fight off the tumor cells in the brain.

Timeline

Start
2018-08-27
Primary completion
2025-03-20
Completion
2025-03-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous Hematopoietic Stem cells (HSCs) Cell therapy 2e+06 cells/kg
Subject TTRNA-DC vaccines Vaccine Other
Subject TTRNA-xALT Cell therapy Intravenous
Background TMZ Unknown
Background Td vaccine Vaccine Intramuscular
Background sargramostim Protein / enzyme biologic 150 ug