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Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3) (PerCellVac3)

Primary Purpose

Brain Cancer, Neoplasm Metastases

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Personalized cellular vaccine
Sponsored by
Guangdong 999 Brain Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Cancer focused on measuring Solid tumors, Brain metastases, DC vaccine, Personalized vaccine, Tumor antigens

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Solid tumor with brain metastases.
  • Patients at the age of 18-65.
  • Patients undergo tumor resection or biopsy.
  • 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:

  • Infectious diseases HIV, HBV, HCV.
  • Documented immunodeficiency.
  • Documented autoimmune disease.
  • Breast feeding females.
  • Pregnant women.
  • 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.

Sites / Locations

  • Guangdong 999 Brain Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Personalized cellular vaccine

Arm Description

Patients will undergo tumor resection or biopsy, and receive biweekly cellular vaccines consisting of mRNA-pulsed autologous DCs.

Outcomes

Primary Outcome Measures

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 vaccines.

Secondary Outcome Measures

Antitumor specific T cell response
The frequency of the peripheral CD8+ and CD4+ T cell response to the vaccine will be measured.
Progression-free survival
Progression-free survival will be monitored for 2 year
Overall survival
Overall survival will be monitored for 3 years

Full Information

First Posted
June 17, 2016
Last Updated
May 23, 2022
Sponsor
Guangdong 999 Brain Hospital
Collaborators
Beijing Tricision Biotherapeutics Inc, Zhuhai Trinomab Pharmaceutical Co., Ltd., Jinan University Guangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT02808416
Brief Title
Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)
Acronym
PerCellVac3
Official Title
Personalized Cellular Vaccine Therapy in Treating Patients With Brain Metastases From Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong 999 Brain Hospital
Collaborators
Beijing Tricision Biotherapeutics Inc, Zhuhai Trinomab Pharmaceutical Co., Ltd., Jinan University Guangzhou

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cancer patients with brain metastases (BM) have poor prognosis. Current treatments produce limited efficacy. Recent advance in cancer immunotherapy has provided important new means to treat cancer patients at advanced stages. This study is designed to perform a clinical trial to treat advanced caner patients with brain metastases with personalized dendritic cell-based cellular vaccines. The patients will receive vaccines consisting of mRNA tumor antigen pulsed DCs. Immune response to the immunized tumor antigens will be monitored. Safety and efficacy will be observed in this study.
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 vaccines for cancer patients with brain metastases (BM). BM patients will undergo tumor resection or biopsy and the tumor tissues will be analyzed for the expression of tumor antigens and immune-related genes. The patients will be immunized with DCs pulsed with mRNA encoded tumor antigens. Patients will be immunized with DC vaccines on a biweekly basis. Safety and efficacy will be monitored. The objective of this study is to assess the safety of the personalized cellular vaccines and to deterimine the antitumor specific T cell responses. The efficacy of the vaccines will be determined using RANO-BM criteria, progression-free survival and overall survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Cancer, Neoplasm Metastases
Keywords
Solid tumors, Brain metastases, DC vaccine, Personalized vaccine, Tumor antigens

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized cellular vaccine
Arm Type
Experimental
Arm Description
Patients will undergo tumor resection or biopsy, and receive biweekly cellular vaccines consisting of mRNA-pulsed autologous DCs.
Intervention Type
Biological
Intervention Name(s)
Personalized cellular vaccine
Intervention Description
Cancer patients with brain metastases will undergo tumor resection or biopsy, and receive tumor antigen mRNA pulsed cellular vaccines. Other Names: • Tumor antigen pulsed DC and PBMC, autologous tumor vaccine
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events and severe adverse events (safety and tolerability)
Description
Incidence of adverse events and severe adverse events to measure safety and tolerability of mRNA-TAA pulsed autologous DC vaccines.
Time Frame
3 years since the beginning of the first vaccine
Secondary Outcome Measure Information:
Title
Antitumor specific T cell response
Description
The frequency of the peripheral CD8+ and CD4+ T cell response to the vaccine will be measured.
Time Frame
4 weeks after the last vaccine
Title
Progression-free survival
Description
Progression-free survival will be monitored for 2 year
Time Frame
24 months since the beginning of the first vaccine
Title
Overall survival
Description
Overall survival will be monitored for 3 years
Time Frame
3 years since the beginning of the first vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Solid tumor with brain metastases. Patients at the age of 18-65. Patients undergo tumor resection or biopsy. 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: Infectious diseases HIV, HBV, HCV. Documented immunodeficiency. Documented autoimmune disease. Breast feeding females. Pregnant women. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Zhang, M.D.
Organizational Affiliation
Guangdong 999 Brain Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong 999 Brain Hospital
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32078016
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/32078016/
Description
Clinical trial results

Learn more about this trial

Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)

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