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Children's Cancer Institute Begins Australian Trial of CAR T-Cell Therapy in Childhood Brain Cancer

NEW YORK – The Children's Cancer Institute Australia said it has launched a clinical trial of a CAR T-cell therapy for diffuse intrinsic pontine glioma with H3K27M alterations.

DIPG is an aggressive childhood brain cancer, which currently has no effective therapies. About 20 Australian children per year are diagnosed with DIPG, and most do not survive longer than 12 months after diagnosis.

The trial is named Levi's Catch after 8-year-old Levi Wheeler, who died from DIPG in 2018. The study will be carried out in two parts. In the first part, patients with DIPG bearing an H3K27M mutation or loss of H3K27 trimethylation will have T cells collected by apheresis, and from those T cells, investigators will generate CAR T cells targeting the tumor-specific antigen GD2. In the second part of the trial, patients will receive the standard chemotherapy and radiation prior to infusion of GD2-iCAR-PBT cells. Patients will also receive up to three doses of Roche's Avastin (bevacizumab) during the weeks surrounding the infusion. If no dose-limiting toxicities are present at eight weeks after infusion, patients will be eligible for up to two additional doses at eight-week intervals.

The primary endpoint of the trial is dose-limiting toxicity. As secondary endpoints, researchers will look at tumor response, progression-free survival, and overall survival. The trial is a collaboration between Children's Cancer Institute, the Kids Cancer Center at Sydney Children's Hospital, Royal Adelaide Hospital, and the University of South Australia, with support from the Cancer Institute New South Wales. It is recruiting patients across Australia.

The trial is funded by Levi's Project, a fund operated by Ben and Kathryn Wheeler, which has contributed $600,000 to the trial.