Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)

Brain Cancer Clinical Trial

— PerCellVac3  

Official title:

Personalized Cellular Vaccine Therapy in Treating Patients With Brain Metastases From Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808416
• Other study ID #: Ag-mRNA-Cell-BM-999Brain
• Status: Completed
• Phase: Phase 1
• Start date: March 1, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: May 2022
• Source: Guangdong 999 Brain Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 30, 2019
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Neoplasm Metastases
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Biological:
• Personalized cellular vaccine
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

Locations

Country	Name	City	State
China	Guangdong 999 Brain Hospital	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Guangdong 999 Brain Hospital	Beijing Tricision Biotherapeutics Inc, Jinan University Guangzhou, Trinomab Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

References & 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 Imm — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years since the beginning of the first vaccine
Secondary	Antitumor specific T cell response	The frequency of the peripheral CD8+ and CD4+ T cell response to the vaccine will be measured.	4 weeks after the last vaccine
Secondary	Progression-free survival	Progression-free survival will be monitored for 2 year	24 months since the beginning of the first vaccine
Secondary	Overall survival	Overall survival will be monitored for 3 years	3 years since the beginning of the first vaccine

External Links

•   Clinical trial results