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| Name | Class |
|---|---|
| Beijing Tricision Biotherapeutics Inc | INDUSTRY |
| Zhuhai Trinomab Pharmaceutical Co., Ltd. | INDUSTRY |
| Jinan University Guangzhou | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized cellular vaccine | Experimental | Patients will undergo tumor resection or biopsy, and receive biweekly cellular vaccines consisting of mRNA-pulsed autologous DCs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized cellular vaccine | Biological | 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 |
| 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 vaccines. | 3 years since the beginning of the first vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Antitumor specific T cell response | The frequency of the peripheral CD8+ and CD4+ T cell response to the vaccine will be measured. | 4 weeks after the last vaccine |
| Progression-free survival | Progression-free survival will be monitored for 2 year |
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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 |
|---|---|
| Clinical trial results | View source |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 24 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 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |