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Mustang Bio Initiates CAR T-Cell Therapy in Phase I Brain Tumor Trial

NEW YORK – Mustang Bio said on Tuesday that the first patient with a leptomeningeal brain tumor has received its autologous CAR T-cell therapy, MB-101, in a Phase I trial.

The trial is taking place at City of Hope, where the treatment was originally developed, and will enroll up to 30 patients with leptomeningeal brain tumors. One arm of the study will include glioblastoma patients, and another will enroll ependymoma or medulloblastoma patients. Study participants will undergo surgery to place an intraventricular Rickham catheter, through which they will receive the CAR T-cell therapy.

MB-101 consists of engineered immune cells that contain CAR T cells directed at IL13Rα2, a receptor overexpressed on glioma cells in about 75 percent of glioblastoma patients but not expressed on normal cells.

The researchers will measure safety, toxicity, and overall survival at three months. The study will also monitor patients' CAR T and endogenous T-cell levels, cytokine levels, and phenotype detection in peripheral blood, tumor cyst fluid, and cerebrospinal fluid.

"Based on our research to date, including a previous clinical trial at City of Hope, further evaluation is warranted for this CAR T-cell therapy," Lisa Feldman, principal investigator of the study, said in a statement, adding that the earlier trial showed the potential of being able to deliver the CAR T-cell treatment intraventricularly to patients with leptomeningeal brain tumors, who are difficult to treat.

Earlier this month, Mustang, based in Worcester, Massachusetts, was cleared by the US Food and Drug Administration to begin a clinical trial of another CAR T-cell therapy, MB-106, in patients with CD20-positive lymphoma and leukemia. That study is expected to start in the third quarter of this year.