Mustang Bio and cancer research and treatment centre City of Hope have commenced a Phase I clinical trial to investigate the safety and effectiveness of intraventricular delivery of CAR T cells to the brains of patients with HER2-positive breast cancer with brain metastases.
The trial aims to enrol 21 patients, with the majority likely to be women with HER2-positive breast cancer.
The trial’s primary endpoint is to find the safety and recommended Phase II dosing of intraventricular delivery of HER2-specific CAR T cells.
Its secondary endpoints are evaluating cerebrospinal fluid (CSF) and peripheral blood for HER2-CAR T cell persistence and endogenous immune system activation, changes in cytokine levels in the CSF and peripheral blood, as well as changes in circulating tumour cells in the CSF.
City of Hope Brain Tumour Programme associate director Jana Portnow said: “For a woman who already has breast cancer, learning that a brain tumour has developed can be a frightening diagnosis because there are few treatment options available.
“CAR T cell therapy may be another tool in our fight against this devastating disease.
“Our hope is that the HER2-specific CAR T cell therapy will target and kill HER2-positive cancer cells, and safely and effectively treat brain metastases in these patients.”
CAR T cell therapy is a cell-based immunotherapy designed to reprogramme a patient’s own T cells to actively seek out and destroy cancerous cells.
As part of the Phase I trial, the patient’s T cells will be isolated from the blood and genetically engineered to express a CAR, enabling the immune cells to target and remove HER2-positive cancer cells.
US-based City of Hope has also dosed the first patient in a Phase I clinical trial evaluating the HER2-specific CAR T cells for the treatment of recurrent or refractory grade III-IV glioma.