Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06172634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-12-07
Brief Title:
A Single-center Clinical Study to Evaluate the Safety and Efficacy of Autologous Bone Marrow-derived DCsCellgramDC-WT1 and Immune Checkpoint Inhibitors in Patients With Metastatic Pancreatic Cancer Who Have Failed First-line or More Standard Chemotherapy
Sponsor:
Soonchunhyang University Hospital
Organization:
Soonchunhyang University Hospital
Study Overview
Official Title:
A Single-center Clinical Study to Evaluate the Safety and Efficacy of Autologous Bone Marrow-derived DCsCellgramDC-WT1 and Immune Checkpoint Inhibitors in Patients With Metastatic Pancreatic Cancer Who Have Failed First-line or More Standard Chemotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DICI_PC
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None