Personalized Cellular Vaccine for Recurrent Glioblastoma (PERCELLVAC2) (PerCellVac2)

Guangdong 999 Brain Hospital

Status and phase: Completed; Phase 1

Conditions: Glioblastoma

Treatments: Biological: Personalized cellular vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02808364

Ag-mRNA-Cell-999brain

Details and patient eligibility

About

The treatment option for recurrent glioblastoma is limited. Immune cell based therapy for glioblastoma has shown some efficacy. This study is designed to perform a personalized clinical trial by first analyzing the expression of tumor associated antigens in patients with recurrent glioblastoma and then immunizing the patients with personalized antigen pulsed DCs. Immune responses to the immunized antigens will be monitored. Safety and efficacy will be observed in this study.

Full description

This is an open label, single-arm, single-institution, Phase I study designed to investigate the safety and efficacy of personalized cellular vaccines for patients with recurrent glioblastoma (GBM). Recurrent GBM patients will undergo tumor resection. The tumors will be analyzed for the expression of a panel of glioma-associated antigens and immune-related genes. Patients will undergo leukapheresis to collect mononuclear cells for DC generation. Based on the expression profiles of tumor-associated antigens, in vitro transcribed mRNA will be generated to pulse autologous DCs. Patients will be conditioned with immune adjuvants before and during immunization. Patients will receive biweekly vaccines. The antitumor specific T cell responses will be measured. Safety and efficacy will be monitored. The objective is to assess the safety of the personalized cellular vaccines and T cell responses. The efficacy of the vaccines will be evaluated using iRANO criteria, progression-free survival and overall survival.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recurrent glioblastoma grade IV
• Patients at the age of 18-65.
• Patients undergo tumor resection.
• Patients with Karnofsky scores > or =70
• Patients with normal range of hematologic and metabolic test results.
• Patients must have no corticosteroids treatment at least one week before vaccination.
• Patients capable of understanding the study and signed informed consent.

Exclusion criteria

• Breast feeding females.
• Pregnant women.
• Infectious diseases HIV, HBV, HCV
• Documented immunodeficiency
• Documented autoimmune disease
• Any serious or uncontrolled medical or psychiatric conditions, for example, severe pulmonary, cardiac or other systemic disease.
• Patient inability to participate as determined by PI discretion.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Personalized cellular vaccine

Experimental group

Description:

Subjects will undergo tumor resection. They will receive biweekly cellular vaccines consisting of mRNA tumor antigen pulsed autologous DCs.

Treatment:

Biological: Personalized cellular vaccine