Status:
UNKNOWN
Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma
Lead Sponsor:
Aivita Biomedical, Inc.
Conditions:
Newly Diagnosed Glioblastoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03400917
Start Date
June 20 2018
End Date
February 1 2023
Last Update
December 16 2021
Active Locations (8)
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1
Scripps Health
La Jolla, California, United States, 92037
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92037
3
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
4
UC Irvine Medical Center
Orange, California, United States, 92868