Mustang Bio (NSDQ:MBIO) said today that it launched a Phase I trial to evaluate the safety and efficacy of intraventricular delivery of CAR T-cells to the brains of people with HER2-positive breast cancer.
The 21-patient trial’s primary goal is to determine the recommended dosing regimen for a Phase II trial. Secondary objectives include evaluating the patients’ cerebrospinal fluid and peripheral blood for HER2-CAR T-cell persistence and activation of the endogenous immune system, the company reported.
“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,” president & CEO Dr. Manuel Litchman said in prepared remarks.
The Phase I trial is being conducted by cancer research and treatment center City of Hope. Mustang Bio also announced today that the first patient was dosed in a Phase I trial of HER2-specific CAR T-cells as a treatment for recurrent or refractory grade III-IV glioma.
“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,” Litchman said.
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