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| Name | Class |
|---|---|
| Beijing Neoantigen Biotechnology Company | UNKNOWN |
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A single-arm, single-center, open-labeled study will be conducted with an aim to investigate the feasibility, safety, and efficacy of the personalized vaccine for patients with recurrent malignant glioma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| personalized vaccine | Experimental | patients with recurrent malignant gliomas enrolled into this arm will receive the personalized vaccine through sub-cutaneous. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| personalized vaccine | Biological | Based on genetic and transcriptional sequencing information, personalized peptide vaccines would be designed and produced; patients would be vaccinated on day 1, 4, 8 ,15, 22 and then on week 12, 20. |
| Measure | Description | Time Frame |
|---|---|---|
| incidences of advent events and severe advent events | would be monitored and measured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.X.) | from initiation of study treatment to 28 weeks post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| object response rate (ORR) according to iRANO criteria | ORR including complete response (CR) and partial response (PR) would be assessed and measured based on the conditions proposed by iRANO criteria | from initiation of study treatment to 24 weeks post-vaccination (last shot) |
| progression free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingtang Lin, M.D., Ph.D. | Contact | 8610-83198114 | 2683 | linqingtang@xwhosp.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100054 | China |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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time interval (measured in weeks) between initiation of study treatment to progression of disease |
| up to 48 weeks post-vaccination(last shot) |
| overall survival (OS) | time interval (measured in weeks) from initiation of study treatment to the death of patients | up to 48 weeks post-vaccination(last shot) |
| immune response based on the criteria encoded by GRT-C903 and GRT-R904 | humoral and cellular immune responses including generation of specific antibodies, inflammatory factors, immune cells, will be measured as proposed by GRT-C903 and GRT-R904 | Baseline to end of treatment (up to approximately 12 months) |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |