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To evaluate the safety and effectiveness of immune cell therapy using autologous bone marrow-derived dendritic cells and immune checkpoint inhibitors in patients with metastatic pancreatic cancer who have failed at least one standard anticancer treatment.
After a test subject agrees in writing to participate in a clinical study, if he or she is determined to fit the selection criteria and does not meet the exclusion criteria through a screening process, he or she is enrolled in the clinical study.
After consenting to the study, subjects set a bone marrow collection date within 7 days of registration, and granulocyte colony-stimulating factor (G-CSF) is administered the day before bone marrow collection. After bone marrow collection (approximately 30-50 ml) on the day of bone marrow collection, autologous bone marrow-derived dendritic cells (Cellgram-DC-WT1) made by isolating CD141+ cells from the bone marrow are administered intravenously together with pembrolizumab, at 3-week intervals. After repeating the test drug administration 3 times at 3-week intervals, a radiological response evaluation of the tumor is performed, and a decision is made to continue or terminate the test drug administration according to the response evaluation results. If the response evaluation results for the tumor fall into a complete response, partial response, or stable disease, administration of the test drug is continued, and the response evaluation is repeated three times at three-week intervals. If the response evaluation result for the tumor is progressive disease, administration of the test drug is terminated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DC + ICI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dentritic cell infusion and immunecheckpoint inhibitor | Drug | dentritic cell infusion and immunecheckpoint inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| treatment related adeverse event | for 1yr |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | treatment response | for 1yr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong ho Won, MD, PhD | Contact | +82 010-7303-1207 | jhwon@schmc.ac.kr |
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dentritic cell + immunechekpoint inhibitor
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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