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

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ClinicalTrials.gov Identifier: NCT02808364
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Collaborators:
Beijing Tricision Biotherapeutics Inc
Guangzhou Trinomab Biotech Co., Ltd.
Jinan University Guangzhou
Information provided by (Responsible Party):
Jian Zhang, Guangdong 999 Brain Hospital

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 cellular vaccines including autologous tumor cells, antigen pulsed DCs and allogeneic peripheral blood mononuclear cells (PBMCs). Safety and efficacy will be observed in this study.

Condition or disease Intervention/treatment Phase
Glioblastoma Biological: Personalized cellular vaccine Phase 1 Phase 2

Detailed Description:
This is an open label, single-arm, single-institution, Phase I/II 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. The tumor cells will be irradiated and used as vaccines. 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 or allogeneic PBMCs. Patients will be conditioned with immune adjuvants before and during immunization. Patients will receive a total of twelve vaccines consisting of autologous tumor cells, DCs or PBMCs. Safety and efficacy will be monitored. The primary objective is to assess the safety of the personalized cellular vaccines. The secondary objective is to assess the efficacy of the vaccines using iRANO criteria, progression-free survival and overall survival. In addition, the antitumor specific T cell responses will be measured.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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)
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Personalized cellular vaccine
Subjects will undergo tumor resection. They will receive a total of 12 cellular vaccines consisting of autologous tumor cells, autologous DCs and allogeneic PBMCs.
Biological: Personalized cellular vaccine
Patients with recurrent glioblastoma will undergo tumor resection and receive tumor antigen pulsed cellular vaccines.
Other Name: Tumor antigen pulsed DC and PBMC, autologous tumor vaccine




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events and severe adverse events (safety and tolerability) [ Time Frame: 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 :
  1. Progression-free survival [ Time Frame: 12 months since the beginning of the first vaccine ]
    Progression-free survival will be monitored for 1 year.

  2. Overall survival [ Time Frame: 3 years since the beginning of the first vaccine ]
    Overall survival will be monitored for 3 years.

  3. Antitumor antigen specific T cell response [ Time Frame: 4 weeks after the last vaccine ]
    The frequency of the peripheral CD8+ and CD4+ T cell response to the vaccine will be measured.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808364


Contacts
Contact: Ying Nie, M.D. 011 86 13609015565 drnieying@163.com
Contact: Qianting Wang, M.S. wangqianting999@163.com

Locations
China, Guangdong
Guangdong 999 Brain Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Ying Nie, M.D.    011 86 13609015565    drnieying@163.com   
Contact: Qianting Wang, M.S.       wangqianting999@163.com   
Principal Investigator: Jian Zhang, M.D.         
Principal Investigator: You-Wen He, M.D. Ph.D.         
Sponsors and Collaborators
Guangdong 999 Brain Hospital
Beijing Tricision Biotherapeutics Inc
Guangzhou Trinomab Biotech Co., Ltd.
Jinan University Guangzhou
Investigators
Principal Investigator: Jian Zhang, M.D. Guangdong 999 Brain Hospital

Responsible Party: Jian Zhang, Vice President of the hospital and Chief Physician, Guangdong 999 Brain Hospital
ClinicalTrials.gov Identifier: NCT02808364     History of Changes
Other Study ID Numbers: Ag-mRNA-Cell-999brain
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jian Zhang, Guangdong 999 Brain Hospital:
Recurrent glioblastoma
DC vaccine
tumor antigen
personalized vaccine

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Vaccines
Immunologic Factors
Physiological Effects of Drugs