Biotech company AIVITA Biomedical revealed on Wednesday that it has received the US Food and Drug Administration's (FDA) clearance for its Investigational New Drug (IND) application for the Phase II clinical trial investigating its ROOT OF CANCER technology in patients with glioblastoma multiforme.

Under the company's single-arm, open-label trial, about 55 patients with newly diagnosed glioblastoma multiforme will be enrolled with the intent to receive the its ROOT OF CANCER treatment. The University of California, Irvine will be the study's first site, with additional sites to follow.

The company said the ROOT OF CANCER treatment consists of the patient's own dendritic cells loaded with tumor antigens from the patient's own tumor-initiating cells. The treatment will be administered in a series of injections along with standard care, which may include surgery, chemotherapy and radiation, as well as checkpoint inhibitors should they eventually be approved as standard care.

In the company's single-arm, open-label trial, the patients who have recovered from surgery and are about to begin concurrent chemotherapy and radiation therapy (CT/RT) will eligible for treatment, in patients where an autologous tumor cell line has been established, patients with a KPS of > 70 as well as patients that have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained to generate dendritic cells (DC).

Glioblastoma Multiforme is the most aggressive and most common form of malignant brain tumor. Median survival is only nine months, rising to 15–16 months for those receiving standard of care surgery and adjuvant chemoradiation. The cause of most cases is unclear.