Brain Cancer, Neoplasm Metastases
Conditions
Keywords
Solid tumors, Brain metastases, DC vaccine, Personalized vaccine, Tumor antigens
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.
Interventions
BIOLOGICALPersonalized 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
Sponsors
Beijing Tricision Biotherapeutics Inc
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Jinan University Guangzhou
Guangdong 999 Brain Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed