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This study is a single-arm, open-label, single-administration dose-escalation study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Armored Dendritic Cell Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Armored Dendritic Cell Injection | Biological | Armored dendritic cells are administered via multiple subcutaneous injections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | Day 0-Month 5 | |
| Evaluate the incidence and severity of adverse events | Adverse events (AEs), serious adverse events (SAEs) and laboratory abnormalities (including their types, frequencies and severity) will be collected. This includes the types, incidence and severity of adverse events, as well as clinically significant abnormal laboratory test results and abnormal physical examination findings that emerge after treatment. Clinical and laboratory adverse events will be primarily graded using Version 6.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). The causal relationship between adverse events and the dendritic cell (DC) product will be assessed by investigators in accordance with the causality evaluation criteria specified in the study protocol. | Day 0-Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | day 0-day28 | |
| antigen-specific T-cell responses | day 0-Month 5 | |
| RFS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Qing | Contact | 13761325567 | xuqing@shcell.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mengchao Tumor Hospital | Recruiting | Shanghai | China |
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1- and 2-year recurrence-free survival rates (RFS)
| day 0-Month 24 |
| Tmax | day 0- day 28 |
| Tlast | day 0-day 28 |
| concentration of tumor markers | day 0-month 5 |