Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)

Guangdong 999 Brain Hospital10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Brain Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 3 years since the beginning of the first vaccine

Secondary Outcomes

Antitumor specific T cell response

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

Progression-free survival

Progression-free survival will be monitored for 2 year

Time frame: 24 months since the beginning of the first vaccine

Overall survival

Overall survival will be monitored for 3 years