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NCT Number: NCT02709616

Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC)

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.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guangdong 999 Brain Hospital

Guangzhou, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Personalized cellular vaccine

Biological

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 names: Tumor antigen pulsed DC vaccine

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Guangdong 999 Brain Hospital

Other

Collaborators

  • Beijing Tricision Biotherapeutics Inc
  • Jinan University Guangzhou
  • Zhuhai Trinomab Pharmaceutical Co., Ltd.

Registry information

Official study title

Personalized Cellular Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma (PerCellVac)

Acronym: PERCELLVAC

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Mar 16, 2016
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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