Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC) (PERCELLVAC)

May 23, 2022 updated by: Jian Zhang, Guangdong 999 Brain Hospital

Personalized Cellular Vaccine Therapy in Treating Patients With Newly Diagnosed 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangdong 999 Brain Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Tumor antigen pulsed DC vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years since the beginning of the first vaccine

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks after the last vaccine
Progression-free survival
Time Frame: 12 months since the beginning of the first vaccine.
Progression-free survival will be monitored for 1year.
12 months since the beginning of the first vaccine.
Overall survival
Time Frame: 3 years since the beginning of the first vaccine
Overall survival will be monitored for 3 years.
3 years since the beginning of the first vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong 999 Brain Hospital

Collaborators

Jinan University Guangzhou
Beijing Tricision Biotherapeutics Inc
Trinomab Biotech Co., Ltd.

Investigators

  • Principal Investigator: Jian Zhang, M.D., Guangdong 999 Brain Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

March 10, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Actual)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ag-mRNA-DC-999brain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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