Clinical trial NCT06172634: 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
Official title: 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 type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Pancreas Cancer
Keywords: dentritic cell
immune checkpoint inhibitors
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: dentritic cell + immunechekpoint inhibitor
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: treatment related adeverse event
timeFrame: for 1yr
Secondary outcomes:
measure: overall response rate
timeFrame: for 1yr
Other outcomes:
Locations:
Study officials:
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