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| Name | Class |
|---|---|
| Jinan University Guangzhou | OTHER |
| Beijing Tricision Biotherapeutics Inc | INDUSTRY |
| Zhuhai Trinomab Pharmaceutical Co., Ltd. | INDUSTRY |
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Dendritic cell-based cellular vaccine for tumor therapy has shown efficacy. This study is designed to perform a personalized clinical trial by first analyzing the expression of tumor associated antigens in patients with newly diagnosed glioblastoma and then immunizing the patients with personalized DC-based cellular vaccine. Immune responses to tumor antigens will be monitored. Safety and efficacy will be observed in the study.
This is an open label, single-arm, single-institution, Phase I study designed to investigate the safety and efficacy of personalized cellular tumor vaccine for patients with newly diagnosed glioblastoma (GBM). Newly diagnosed 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. Post surgical treatment will be 6 weeks standard chemotherapy with temozolomide and concurrent radiotherapy and continue cycles of temozolomide within a 28-day window. Patients will undergo leukapheresis either after surgery or after concurrent radio/chemotherapy. Based on individual tumor antigen expression, in vitro transcribed mRNA will be generated and used to pulse in vitro generated DCs. The patients will be immunized i.d. and i.v. biweekly with DC cellular vaccines. Safety and efficacy will be monitored. The primary objective is to assess the safety of the personalized cellular vaccines. The secondary objective is to assess the specific T cell response to immunized vaccines. In addition, the antitumor efficacy of the vaccines will be measured using iRANO criteria, progression-free survival and overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized cellular vaccine | Experimental | DC based cellular vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized cellular vaccine | Biological | Biological: DC-based cellular vaccine. Subjects will undergo surgical resection and standard 6-week chemo/radiotherapy and cycles of TMZ treatment. They will receive biweekly cellular vaccines. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 cellular vaccine | 3 years since the beginning of the first vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Antitumor antigen specific T cell response | The frequency of peripheral CD8+ and CD4+ T cell response to the vaccine. | 4 weeks after the last vaccine |
| Progression-free survival | Progression-free survival will be monitored for 1year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Zhang, M.D. | Guangdong 999 Brain Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong 999 Brain Hospital | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32078016 | Result | 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 Immunother. 2020 Jul;69(7):1375-1387. doi: 10.1007/s00262-020-02496-w. Epub 2020 Feb 20. |
| Label | URL |
|---|---|
| Publication of the trial results | View source |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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|
| 12 months since the beginning of the first vaccine. |
| Overall survival | Overall survival will be monitored for 3 years. | 3 years since the beginning of the first vaccine |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |