NCT03400917

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Aivita Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	AV-GBM-1	Investigational treatment with AV-GBM-1

Timeline

• Start date: 2018-06-20
• Primary completion: 2021-12-01
• Completion: 2023-02-01
• First posted: 2018-01-17
• Last updated: 2021-12-16

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study