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

NCT ID: NCT03400917

Last Updated: 2021-12-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-20
• Study Completion Date: 2023-02-28

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).

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.

Conditions

Newly Diagnosed Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AV-GBM-1

Intervention Type: BIOLOGICAL

Investigational treatment with AV-GBM-1

Interventions

AV-GBM-1

Investigational treatment with AV-GBM-1

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aivita Biomedical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert O Dillman, MD

Role: STUDY_CHAIR

Aivita Biomedical, Inc.

Locations

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

Countries

United States

References

Bota DA, Taylor TH, Piccioni DE, Duma CM, LaRocca RV, Kesari S, Carrillo JA, Abedi M, Aiken RD, Hsu FPK, Kong XT, Hsieh C, Bota PG, Nistor GI, Keirstead HS, Dillman RO. Phase 2 study of AV-GBM-1 (a tumor-initiating cell targeted dendritic cell vaccine) in newly diagnosed Glioblastoma patients: safety and efficacy assessment. J Exp Clin Cancer Res. 2022 Dec 14;41(1):344. doi: 10.1186/s13046-022-02552-6.

Reference Type: DERIVED

PMID: 36517865 (View on PubMed)

Other Identifiers

CL-GBM-P01

Identifier Type: -

Identifier Source: org_study_id