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Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC) (PERCELLVAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02709616
Recruitment Status : Active, not recruiting
First Posted : March 16, 2016
Last Update Posted : June 7, 2019
Sponsor:
Collaborators:
Jinan University Guangzhou
Beijing Tricision Biotherapeutics Inc
Guangzhou Trinomab Biotech Co., Ltd.
Information provided by (Responsible Party):
Jian Zhang, Guangdong 999 Brain Hospital

Brief Summary:
Dendritic cell-based cellular vaccine for tumor therapy has shown efficacy. This study is designed to perform a personalized clinical trial by first analyzing the expression of tumor associated antigens in patients with newly diagnosed glioblastoma and then immunizing the patients with personalized DC-based cellular vaccine. Immune responses to tumor antigens will be monitored. Safety and efficacy will be observed in the 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 tumor vaccine for patients with newly diagnosed glioblastoma (GBM). Newly diagnosed 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. Post surgical treatment will be 6 weeks standard chemotherapy with temozolomide and concurrent radiotherapy and continue cycles of temozolomide within a 28-day window. Patients will undergo leukapheresis either after surgery or after concurrent radio/chemotherapy. Based on individual tumor antigen expression, in vitro transcribed mRNA will be generated and used to pulse in vitro generated DCs. The patients will be immunized i.d. and i.v. biweekly with DC cellular vaccines. 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 specific T cell response to immunized vaccines. In addition, the antitumor efficacy of the vaccines will be measured using iRANO criteria, progression-free survival and overall survival.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalized Cellular Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma (PerCellVac)
Study Start Date : March 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Personalized cellular vaccine
DC based cellular vaccine
Biological: Personalized cellular vaccine
Biological: DC-based cellular vaccine. Subjects will undergo surgical resection and standard 6-week chemo/radiotherapy and cycles of TMZ treatment. They will receive biweekly cellular vaccines.
Other Name: Tumor antigen pulsed DC 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 cellular vaccine


Secondary Outcome Measures :
  1. Antitumor antigen specific T cell response [ Time Frame: 4 weeks after the last vaccine ]
    The frequency of peripheral CD8+ and CD4+ T cell response to the vaccine.

  2. Progression-free survival [ Time Frame: 12 months since the beginning of the first vaccine. ]
    Progression-free survival will be monitored for 1year.

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



Information from the National Library of Medicine

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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:

  • Newly diagnosed glioblastoma grade IV
  • Patients at the age of 18-65.
  • Patients must have undergone maximal surgical resection of the tumor.
  • 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): NCT02709616


Locations
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China, Guangdong
Guangdong 999 Brain Hospital
Guangzhou, Guangdong, China
Sponsors and Collaborators
Guangdong 999 Brain Hospital
Jinan University Guangzhou
Beijing Tricision Biotherapeutics Inc
Guangzhou Trinomab Biotech Co., Ltd.
Investigators
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Principal Investigator: Jian Zhang, M.D. Guangdong 999 Brain Hospital

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Responsible Party: Jian Zhang, Jian Zhang, MD, Professor, Vice President of Guangdong 999 Brain Hospital, Chairman, Department of Surgery, Guangdong 999 Brain Hospital
ClinicalTrials.gov Identifier: NCT02709616     History of Changes
Other Study ID Numbers: Ag-mRNA-DC-999brain
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jian Zhang, Guangdong 999 Brain Hospital:
Glioblastoma
DC vaccine
tumor antigen
personalized vaccine
Additional relevant MeSH terms:
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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