Glioblastoma
Conditions
Keywords
Recurrent glioblastoma, DC vaccine, tumor antigen, personalized vaccine
Brief summary
The treatment option for recurrent glioblastoma is limited. Immune cell based therapy for glioblastoma has shown some efficacy. This study is designed to perform a personalized clinical trial by first analyzing the expression of tumor associated antigens in patients with recurrent glioblastoma and then immunizing the patients with personalized antigen pulsed DCs. Immune responses to the immunized 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 vaccines for patients with recurrent glioblastoma (GBM). Recurrent GBM patients will undergo tumor resection. The tumors will be analyzed for the expression of a panel of glioma-associated antigens and immune-related genes. Patients will undergo leukapheresis to collect mononuclear cells for DC generation. Based on the expression profiles of tumor-associated antigens, in vitro transcribed mRNA will be generated to pulse autologous DCs. Patients will be conditioned with immune adjuvants before and during immunization. Patients will receive biweekly vaccines. The antitumor specific T cell responses will be measured. Safety and efficacy will be monitored. The objective is to assess the safety of the personalized cellular vaccines and T cell responses. The efficacy of the vaccines will be evaluated using iRANO criteria, progression-free survival and overall survival.
Interventions
BIOLOGICALPersonalized cellular vaccine
Patients with recurrent glioblastoma will undergo tumor resection and receive tumor antigen pulsed cellular vaccines.
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
* Recurrent glioblastoma grade IV * Patients at the age of 18-65. * Patients undergo tumor resection. * 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
* Breast feeding females. * Pregnant women. * Infectious diseases HIV, HBV, HCV * Documented immunodeficiency * Documented autoimmune disease * 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, allogeneic PBMCs and autologous tumor cellular vaccines. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antitumor antigen 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 | 12 months since the beginning of the first vaccine | Progression-free survival will be monitored for 1 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