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

Newly Diagnosed Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03400917
• Other study ID #: CL-GBM-P01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 20, 2018
• Est. completion date: February 2023

Study information

• Verified date: December 2021
• Source: Aivita Biomedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: February 2023
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Newly Diagnosed Glioblastoma

Intervention

Biological:
• AV-GBM-1
Investigational treatment with AV-GBM-1

Locations

Country	Name	City	State
United States	Scripps Health	La Jolla	California
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Rutgers Cancer Institute	New Brunswick	New Jersey
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

Sponsors (1)

Lead Sponsor	Collaborator
Aivita Biomedical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Endpoint: Overall Survival	Overall Survival: time to death from date of enrollment for intent-to-treat with AV-GBM-1	3 years