A Single-center Clinical Study to Evaluate the Safety and Efficacy of Autologous Bone Marrow-derived DCs(CellgramDC-WT1) and Immune Checkpoint Inhibitors in Patients With Metastatic Pancreatic Cancer Who Have Failed First-line or More Standard Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Single-center Clinical Study to Evaluate the Safety and Efficacy of Autologous Bone Marrow-derived DCs(CellgramDC-WT1) and Immune Checkpoint Inhibitors in Patients With Metastatic Pancreatic Cancer Who Have Failed First-line or More Standard Chemotherapy

Conditions
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Pancreas Cancer

Intervention / Treatment
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* Drug: dentritic cell infusion and immunecheckpoint inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients histologically confirmed to have pancreatic cancer and diagnosed as recurrent or metastatic Patients whose disease was confirmed to have progressed according to RECIST v1.1 after 1st or more standard anticancer treatments Patients satisfying systemic performance status ECOG 0-2 Patients who have not undergone surgery, radiation therapy, or immunotherapy within 4 weeks and have recovered from side effects (However, tissue collection procedures that do not affect the test subject's condition are permitted at the discretion of the researcher.) Patients who voluntarily agreed in writing to participate in this clinical study Exclusion Criteria: Patients with malignant tumors other than non-melanoma skin cancer in the past 3 years Patients who have previously received anti-tumor immunotherapy (anti-PD1, anti-PDL-1, or CTLA4 inhibitor, etc.) or participated in clinical studies related to immunotherapy or cell therapy Patients with active autoimmune disease requiring systemic immunosuppressive treatment Patients with a history of organ or hematopoietic stem cell transplantation Patients with acute or chronic infection requiring systemic treatment Other cases where the test manager determines that it is not suitable for clinical research

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: dentritic cell + immunechekpoint inhibitor
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DC + ICI<br> | Drug: dentritic cell infusion and immunecheckpoint inhibitor<br>* dentritic cell infusion and immunecheckpoint inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment related adeverse event |  | for 1yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate | treatment response | for 1yr | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dentritic cell, immune checkpoint inhibitors