Clinical Trial Details
Braintumor Website

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NCT03400917 : Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: 70 Years
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

- Known hypersensitivity to GM-CSF

- Pregnancy
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