On October 30, 2018 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology and gene therapies for rare diseases, reported that a Phase 1 clinical trial evaluating the safety and effectiveness of intraventricular delivery of CAR T cells to the brains of patients with HER2-positive breast cancer with brain metastases has been initiated (Press release, Mustang Bio, OCT 30, 2018, View Source [SID1234530379]).
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The trial, which is being conducted by City of Hope, a world-renowned independent cancer research and treatment center, is expected to enroll 21 patients, many of whom are likely to be women with HER2-positive breast cancer. According to the American Cancer Society, about 1 in 5 patients with breast cancer have HER2- positive cancer cells. Nearly half of patients with HER2-positive breast cancer develop brain metastases.
Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are pleased that this innovative clinical trial, which is the first to deliver HER2-specific CAR T cell therapy directly to the brains of patients whose breast cancer has metastasized to the brain, is now underway. There are currently few treatments available for these patients, and we are hopeful that our CAR T cell therapy will offer a safe and effective option to treat this terrible disease."
The trial’s primary objective is to determine the safety and recommended Phase 2 dosing of intraventricular delivery of HER2-specific CAR T cells. Secondary objectives include assessing cerebrospinal fluid (CSF) and peripheral blood for HER2-CAR T cell persistence and endogenous immune system activation, describing changes in cytokine levels in the CSF and peripheral blood and describing changes in circulating tumor cells in the CSF.
In addition, Mustang has announced that City of Hope has dosed the first patient in a Phase 1 clinical trial of HER2-specific CAR T cells in treating recurrent or refractory grade III-IV glioma. The trial will evaluate the side effects and best dose of HER2-specific CAR T cells in treating patients with grade III-IV glioma that has come back or does not respond to treatment. Dr. Litchman added, "The advancement of these clinical trials marks an exciting time for Mustang. We look forward to learning more about how we can better treat patients with HER2-positive brain metastases or gliomas."