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

Status unconfirmed · Phase 2

Conditions studied: Newly Diagnosed Glioblastoma

In brief

This is a single-arm, open-label phase II clinical trial in which approximately 55 patients with newly diagnosed glioblastoma (GBM) will be enrolled with the intent to receive an autologous dendritic cell vaccine consisting of autologous dendritic cells loaded with autologous tumor-associated antigens (AV-GBM-1).

Key facts

Study ID

NCT03400917

Run by

Aivita Biomedical, Inc.

People needed

55

Starts

2018-06-20

Expected to finish

2023-02-01

Last updated by the study team

2021-12-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scripps Health — La Jolla, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• UC Irvine Medical Center — Orange, California, United States
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• John Wayne Cancer Institute — Santa Monica, California, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Rutgers Cancer Institute — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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