PerCellVac3: Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)

Sponsor

Guangdong 999 Brain Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02808416

Collaborator

Beijing Tricision Biotherapeutics Inc (Industry), Trinomab Biotech Co., Ltd. (Industry), Jinan University Guangzhou (Other)

Enrollment

Location

Arm

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Cancer Neoplasm Metastases	Biological: Personalized cellular vaccine	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Oct 31, 2017

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Personalized cellular vaccine Patients will undergo tumor resection or biopsy, and receive biweekly cellular vaccines consisting of mRNA-pulsed autologous DCs.	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

Arm

Intervention/Treatment

Experimental: Personalized cellular vaccine

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

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

Outcome Measures

Primary Outcome Measures

Incidence of treatment-emergent adverse events and severe adverse events (safety and tolerability) [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 vaccines.

Secondary Outcome Measures

Antitumor specific T cell response [4 weeks after the last vaccine]
The frequency of the peripheral CD8+ and CD4+ T cell response to the vaccine will be measured.
Progression-free survival [24 months since the beginning of the first vaccine]
Progression-free survival will be monitored for 2 year
Overall survival [3 years since the beginning of the first vaccine]
Overall survival will be monitored for 3 years

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.