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Trial record 31 of 1115 for:    Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation, Approved for marketing Studies | glioblastoma

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

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. Identifier: NCT02808364
Recruitment Status : Active, not recruiting
First Posted : June 21, 2016
Last Update Posted : June 7, 2019
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 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.

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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 Recurrent Glioblastoma (PerCellVac2)
Study Start Date : June 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

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 Name: Tumor antigen pulsed DC autologous cellular 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. 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.

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

  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

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 identifier (NCT number): NCT02808364

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

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Responsible Party: Jian Zhang, Vice President of the hospital and Chief Physician, Guangdong 999 Brain Hospital 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 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:
Recurrent glioblastoma
DC vaccine
tumor antigen
personalized vaccine
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Immunologic Factors
Physiological Effects of Drugs