PerCellVac2: Personalized Cellular Vaccine for Recurrent Glioblastoma (PERCELLVAC2)

Sponsor

Guangdong 999 Brain Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02808364

Collaborator

Beijing Tricision Biotherapeutics Inc (Industry), Trinomab Biotech Co., Ltd. (Industry), Jinan University Guangzhou (Other)

Enrollment

Location

Arm

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma	Biological: Personalized cellular vaccine	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Personalized Cellular Vaccine Therapy in Treating Patients With Recurrent Glioblastoma (PerCellVac2)

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Oct 31, 2017

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Personalized cellular vaccine Subjects will undergo tumor resection. They will receive biweekly cellular vaccines consisting of mRNA tumor antigen pulsed autologous DCs.	Biological: Personalized cellular vaccine Patients with recurrent glioblastoma will undergo tumor resection and receive tumor antigen pulsed cellular vaccines. Other Names: Tumor antigen pulsed DC autologous cellular vaccine

Arm

Intervention/Treatment

Experimental: Personalized cellular vaccine

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

Biological: Personalized cellular vaccine

Patients with recurrent glioblastoma will undergo tumor resection and receive tumor antigen pulsed cellular vaccines.

Other Names:

Tumor antigen pulsed DC autologous cellular vaccine

Outcome Measures

Primary Outcome Measures

Incidence of treatment-emergent adverse events and severe adverse events (safety and tolerability) [3 years since the beginning of the first vaccine]
Incidence of adverse events and severe adverse events to measure safety and tolerability of mRNA-TAA pulsed autologous DC, allogeneic PBMCs and autologous tumor cellular vaccines.

Secondary Outcome Measures

Antitumor antigen specific T cell response [4 weeks after the last vaccine]
The frequency of the peripheral CD8+ and CD4+ T cell response to the vaccine will be measured.
Progression-free survival [12 months since the beginning of the first vaccine]
Progression-free survival will be monitored for 1 year.
Overall survival [3 years since the beginning of the first vaccine]
Overall survival will be monitored for 3 years.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.