NCT02709616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

1.7 years

First QC Date

March 7, 2016

Last Update Submit

May 23, 2022

Conditions

Glioblastoma

Keywords

GlioblastomaDC vaccinetumor antigenpersonalized vaccine

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent adverse events and severe adverse events [safety and Tolerability]

    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 Outcomes (3)

  • Antitumor antigen specific T cell response

    4 weeks after the last vaccine

  • Progression-free survival

    12 months since the beginning of the first vaccine.

  • Overall survival

    3 years since the beginning of the first vaccine

Study Arms (1)

Personalized cellular vaccine

EXPERIMENTAL

DC based cellular vaccine

Biological: Personalized cellular vaccine

Interventions

Personalized cellular vaccineBIOLOGICAL

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.

Also known as: Tumor antigen pulsed DC vaccine
Personalized cellular vaccine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong 999 Brain Hospital

Guangzhou, Guangdong, China

Location

Related Publications (1)

  • Wang QT, Nie Y, Sun SN, Lin T, Han RJ, Jiang J, Li Z, Li JQ, Xiao YP, Fan YY, Yuan XH, Zhang H, Zhao BB, Zeng M, Li SY, Liao HX, Zhang J, He YW. Tumor-associated antigen-based personalized dendritic cell vaccine in solid tumor patients. Cancer Immunol Immunother. 2020 Jul;69(7):1375-1387. doi: 10.1007/s00262-020-02496-w. Epub 2020 Feb 20.

    PMID: 32078016RESULT

Related Links

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Jian Zhang, M.D.

    Guangdong 999 Brain Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jian Zhang, MD, Professor, Vice President of Guangdong 999 Brain Hospital, Chairman, Department of Surgery

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 16, 2016

Study Start

March 1, 2016

Primary Completion

October 31, 2017

Study Completion

June 30, 2019

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations

CN(1)