May 01, 2025
The University of Kansas Cancer Center is the lead site in a multicenter trial exploring a new treatment approach for people with newly diagnosed glioblastoma. This investigational study is testing a personalized treatment designed to enhance the body’s own immune system in a targeted response against brain tumors. The concept of the therapy utilized in the study was first devised and tested at the University of Kansas Medical Center.
Glioblastoma is the most common and most aggressive primary brain tumor in adults. Despite aggressive treatments, these tumors almost always recur, often within the first year of treatment. One of the reasons for this high rate of recurrence is glioblastoma’s ability to suppress the body’s natural immune response against the tumor.
Led by Kansas City-based company TVAX Biomedical, the TVI-Brain-1 study is a phase 2b randomized clinical trial evaluating the safety and effectiveness of combining standard therapy with a novel personalized vaccine in people with newly diagnosed, surgically resectable MGMT unmethylated (O6-methylguanine methyltransferase negative) glioblastoma. The clinical study, launched in 2023, is being conducted at academic and corporate hospital clinical sites around the US. Neuro-oncologist Tolga Tuncer, MD, assistant professor of Neurosurgery and Medical Oncology, serves as site principal investigator at KU Cancer Center.
As part of the study, the process begins with collecting tumor tissue during surgery. For participants randomized to the investigational arm, this tissue is then used to create a patient-specific vaccine, which is designed to stimulate an immune response against the tumor. After vaccination, the participant’s immune T cells are harvested, stimulated and expanded at a manufacturing facility. Following standard chemoradiation, the manufactured/stimulated T cells are reinfused back into the patient. Clinicians closely monitor patients in both study arms with routine imaging and follow-up evaluations.
“Glioblastoma remains one of the most challenging cancers to treat,” Dr. Tuncer said. “Participating in research like this gives our patients access to innovative approaches that may help define the next standard of care for glioblastoma in the future.”