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: Pancreas Cancer

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.

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.

Eligibility criteria:
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

Keywords: dentritic cell immune checkpoint inhibitors