Personalized Cellular Vaccine for Recurrent Glioblastoma (PERCELLVAC2)

Glioblastoma Clinical Trial

— PerCellVac2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808364
• Other study ID #: Ag-mRNA-Cell-999brain
• Status: Completed
• Phase: Phase 1
• Start date: March 1, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: May 2022
• Source: Guangdong 999 Brain Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 30, 2019
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Biological:
• Personalized cellular vaccine
Patients with recurrent glioblastoma will undergo tumor resection and receive tumor antigen pulsed cellular vaccines.

Locations

Country	Name	City	State
China	Guangdong 999 Brain Hospital	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Guangdong 999 Brain Hospital	Beijing Tricision Biotherapeutics Inc, Jinan University Guangzhou, Trinomab Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

Wang QT, Nie Y, Sun SN, Lin T, Han RJ, Jiang J, Li Z, Li JQ, Xiao YP, Fan YY, Yuan XH, Zhang H, Zhao BB, Zeng M, Li SY, Liao HX, Zhang J, He YW. Tumor-associated antigen-based personalized dendritic cell vaccine in solid tumor patients. Cancer Immunol Imm — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events and severe adverse events (safety and tolerability)	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.	3 years since the beginning of the first vaccine
Secondary	Antitumor antigen specific T cell response	The frequency of the peripheral CD8+ and CD4+ T cell response to the vaccine will be measured.	4 weeks after the last vaccine
Secondary	Progression-free survival	Progression-free survival will be monitored for 1 year.	12 months since the beginning of the first vaccine
Secondary	Overall survival	Overall survival will be monitored for 3 years.	3 years since the beginning of the first vaccine

External Links

•   Clinical trial results