UNC Health is leading the way in glioblastoma treatment with a new clinical trial set to begin in 2023. The study will evaluate the safety and tolerability of CAR-T immunotherapy in patients with recurrent or progressive glioblastoma.
Glioblastoma is the most common and aggressive primary brain tumor in adults. The standard of care for glioblastoma remains unchanged since 2005. The median survival of patients with newly diagnosed glioblastoma is 15 to 18 months.
Yasmeen Rauf, MD, assistant professor in the UNC Health departments of neurology and neurosurgery and interim division chief for neuro-oncology, will lead the study.
"Glioblastoma is an incurable brain tumor," Rauf said. "Thousands of scientists all over the world are trying to find a cure for this fatal disease."
Rauf's clinical and research interests are focused on management and treatment of glioblastoma.
"This clinical trial will enroll glioblastoma patients who have previously failed one or more treatments," Rauf said.
CAR-T is a process that involves extracting specific immune cells from the patients, engineering the cells in the lab to identify tumor cells displaying a specific molecular target, and then re-infusing the cells to fight the patient's brain tumor. The T cells are programmed to have 'Chimeric Antigen Receptors' or CARs. The new receptors enable the T cells to latch onto the patient-specific antigen on the tumor cells and destroy them.
Gianpietro Dotti, MD, professor of immunology and director of cancer cellular immunotherapy, has developed the CAR-T against the B7H3 receptors, which will be used in this clinical trial. The CAR-T will be manufactured at the UNC Lineberger Clinical Therapeutics Lab in Chapel Hill.
"At UNC, Dr Dotti and his team have developed CAR-T targeting the B7H3 receptor," Rauf said. "We are very excited to announce a Phase 1, single center, open label study using CAR-T cells targeting the B7H3 antigen in patients with a diagnosis of recurrent glioblastoma."
Neurosurgeon and Assistant Professor in the Department of Neurosurgery Dominique Higgins, MD, PhD, will work with Rauf and Dotti in this clinical trial.
"Immunotherapy is an exciting new avenue of therapy for glioblastoma patients with tremendous promise," Higgins said. "UNC is uniquely positioned to lead the charge using our in-house manufacturing capabilities and the expertise of our team. We believe that our CAR-T therapy approach will be a safe and effective treatment for this terrible disease."
UNC Lineberger Comprehensive Cancer Center is one of a select few academic centers in the United States with the scientific, technical and clinical capabilities to identify new tumor targets and then develop and infuse novel CAR-T immunotherapy.
UNC Lineberger opened its advanced cellular therapeutics facility in 2015. The facility, which is certified to use Current Good Manufacturing Practices as set by the FDA, is located approximately five miles off campus. In this facility, cellular therapy products are generated and expanded for patients receiving adoptive cell therapy for the treatment of cancer.
This is an exciting step towards finding a cure for patients diagnosed with glioblastoma.
"This experiment offers new hope to patients not just in North Carolina but also all over the world," Rauf said.
To request to join the study, please visit the study's official page on clinicaltrials.gov.
