Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma

This is a single-arm, open-label phase II clinical trial in which approximately 55 patients
will be enrolled with the intent to receive AV-GBM-1. Patients eligible for treatment will be
those (1) who have recovered from surgery such that they are about to begin concurrent
chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has
been established, (3) have a KPS of > 70, and (4) have undergone successful leukapheresis
from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to
generate dendritic cells (DC).

The primary endpoint of this trial is overall survival (OS), death from any cause measured
from the date of study enrollment for treatment with AV-GBM-1. Secondary endpoints will
include (1) PFS measured from date of enrollment, (2) OS/PFS measured from date of diagnosis
and (3) OS/PFS from date of enrollment based on KPS, age, and extent of surgical resection.
Tertiary endpoints will include (1) OS/PFS from date of first injection and (2) OS/PFS from
date of first injection in patients who completed concurrent CT/RT and had not progressed.

Patient Population: Patients 18 years or older with newly diagnosed glioblastoma [World
Health Organization (WHO) Grade IV glioma, Grade IV anaplastic astrocytoma, glioblastoma or
gliosarcoma, glioblastoma multiforme (GBM)] who have recovered from surgery, for whom an
autologous tumor cell culture and leukapheresis product are available, who have a KPS of >
70, and who are about to begin concurrent CT/RT.

Inclusion Criteria:

- Karnofsky Performance Score of 70-100%

- Histology confirmed to be GBM (Grade IV WHO, glioblastoma, gliosarcoma)

- Successful establishment of an autologous cancer cell line by AIVITA Biomedical, Inc.

- Collection of a satisfactory leukapheresis product

- About to begin concurrent CT/RT

- Given written informed consent to participate in the study

Exclusion Criteria:

- Known to have active hepatitis B or C or HIV

- Karnofsky Performance Score of < 70%

- Known underlying cardiac disease associated with myocardial dysfunction that requires
active medical treatment, or unstable angina related to atherosclerotic cardiovascular
disease, or under treatment for arterial or venous peripheral vascular disease

- Diagnosis of any other invasive cancer or other disease process which is considered to
be life-threatening within the next five years, and/or taking anti-cancer therapy for
cancer other than GBM

- Active infection or other active medical condition that could be eminently
life-threatening, including active blood clotting or bleeding diathesis.

- Known autoimmune disease, immunodeficiency, or disease process that involves the
chronic use of immunosuppressive therapy.

- Received another investigational drug within 28 days of the first dose or are planning
to receive another investigational drug while receiving this investigational
treatment.

- Known hypersensitivity to GM-CSF

- Pregnancy