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 (DICI_PC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreas Cancer
• Intervention / Treatment: Drug: dentritic cell infusion and immunecheckpoint inhibitor

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jong ho Won, MD, PhD; Phone Number: +82 010-7303-1207; Email: jhwon@schmc.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DC + ICI	Drug: dentritic cell infusion and immunecheckpoint inhibitor; dentritic cell infusion and immunecheckpoint inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
treatment related adeverse event	for 1yr

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Soonchunhyang University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Estimated): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: immune checkpoint inhibitors; dentritic cell
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: DC_ICI_PC_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No