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

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ClinicalTrials.gov Identifier: NCT03400917
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Aivita Biomedical, Inc.

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 cell vaccine consisting of autologous dendritic cells loaded with autologous tumor-associated antigens (AV-GBM-1).

Condition or disease Intervention/treatment Phase
Newly Diagnosed Glioblastoma Biological: AV-GBM-1 Phase 2

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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens (AV-GBM-1) as an Adjunctive Therapy Following Primary Surgery Plus Concurrent Chemoradiation in Patients With Newly Diagnosed Glioblastoma
Actual Study Start Date : June 20, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AV-GBM-1
Autologous dendritic cells loaded with tumor associated antigens from a short-term cell culture of autologous tumor cells. AV-GBM-1 is admixed with granulocyte-macrophage colony stimulating factor (GM-CSF) as an adjuvant, prior to injection.
Biological: AV-GBM-1
Investigational treatment with AV-GBM-1




Primary Outcome Measures :
  1. Primary Efficacy Endpoint: Overall Survival [ Time Frame: 3 years ]
    Overall Survival: time to death from date of enrollment for intent-to-treat with AV-GBM-1



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400917


Contacts
Contact: Candace Hsieh, PhD 949-872-2555 ext 110 candace@aivitabiomedical.com

Locations
United States, California
UC Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Jinah Chung    714-456-5431    jinahec@uci.edu   
Principal Investigator: Daniela A Bota, MD, PhD         
Sponsors and Collaborators
Aivita Biomedical, Inc.
Investigators
Study Chair: Robert O Dillman, MD Aivita Biomedical, Inc.

Responsible Party: Aivita Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT03400917     History of Changes
Other Study ID Numbers: CL-GBM-P01
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue