AIVITA Biomedical has dosed the first two patients in its Phase II clinical trial of AV-GBM-1 to treat patients with newly diagnosed glioblastoma (GBM).
Patients were dosed under the guidance of principal investigator Daniela Bota from the University of California Irvine's (UCI) Comprehensive Brain Tumour Programme.
The single-arm, open-label trial is expected to enrol around 55 patients who will receive subcutaneous injections of AV-GBM-1 alongside standard care.
It will include patients who have recovered from surgery and are about to begin concurrent chemotherapy and radiation therapy (CT/RT).
Eligible patients will have an established autologous tumour cell line, a karnofsky performance status (KPS) of >70, and will have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained to produce dendritic cells (DC).
The trial’s primary objective is overall survival (OS), while its secondary objectives comprise progression-free survival (PFS), OS/PFS measured from date of diagnosis, and OS/PFS from date of enrollment based on KPS, age, and extent of surgical resection.
Tertiary objectives of the trial are OS/PFS from date of first injection, and OS/PFS from date of first injection in patients who completed concurrent CT/RT and had not progressed.
AIVITA recently added the University of California, San Diego and John Wayne Cancer Institute as clinical sites for the study.