summary: Researchers are testing a new personalized immunotherapy approach designed to work similar to a vaccine by training the immune system to fight glioblastoma brain cancer.
source: University of Cincinnati
Glioblastoma (GBM) is the most aggressive and lethal type of brain tumor, with less than 7% of patients surviving 5 years after diagnosis.
The University of Cincinnati is a study site for a new Phase 2b clinical trial, sponsored by biotechnology company Imvax, Inc. That will test a personalized immunotherapy approach designed to work similarly to a vaccine by training the immune system to fight a tumor.
The trial will enroll patients newly diagnosed with GBM, explained Dr. Soma Sengupta, MD, PhD, the site’s principal investigator and physician and researcher at the University of Cincinnati Cancer Center. The patients will undergo brain tumor surgery at the UC Gardner Neuroscience Institute to remove the tumors, and researchers will create a custom vaccine from the patients’ own brain cancer cells.
From there, the cancer cells will be shipped to an Imvax facility. The cells are combined with a drug called IMV-001 and incubated in biopropagation chambers to form a personalized immunotherapy against a patient’s specific cancer cells.
The chambers are then implanted into the patient’s abdomen and removed 48 hours later, after the immune system has had a chance to train itself to fight the tumor.
“Your immune system then acts on that tumor,” said Sengupta, UCLA associate professor of neuroscience, director of neuro-oncology clinical trials, associate director of the Brain Tumor Center and neuro-oncologist at UCLA funded by Harold C. • The Schott Chair in Molecular Therapy (Neurosurgery) and the Pam and Tom Michell Fund.
“It’s an immune-mediated, evolved vaccine from your own body, and it’s personalized medicine at its best.”
Patients in the trial will be randomized to either receive personalized immunotherapy or a placebo from an inactivated solution in a biodissemination chamber. After the chambers are removed, patients will continue with the current standards of care of outpatient chemotherapy and radiation after surgery.
Phase I trials showed that the approach was safe, and this phase of the trial will evaluate progression-free survival and overall survival for patients treated with Imvax.
“Survival with this standard of care with surgery, radiation and chemotherapy takes about two years, and this treatment has promise for extending survival beyond that,” Sengupta said.
“The initiation of a Phase 2b trial of cell-based autologous immunotherapy is a major milestone for patients with GBM,” said David W. Andrews, Imvax’s chief medical officer. “Imvax is indebted to the academic leaders like Dr. Sengupta and the University of Cincinnati who are participating in this trial for the benefit of these patients.
“We hope that this trial will eventually provide support for a new and better treatment option for the many patients diagnosed each year with this incurable disease.”
A total of 93 patients across up to 25 trial sites will be enrolled in the trial, and an estimated seven to 14 patients are expected to be enrolled at UCSD.
NB: Patients must be newly diagnosed with GBM and have not yet undergone surgery to be eligible for the study.
For more information, call University of Cincinnati Brain Tumor Nurse Center Jamie Denlinger, RN, at 513-675-9656.
About this brain cancer research news
author: Tim Tedeschi
source; University of Cincinnati
communication: Tim Tedeschi – University of Cincinnati
picture: The image is in the public domain