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

NCT ID: NCT06172634

Last Updated: 2023-12-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-12-31

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.

Conditions

Pancreas Cancer

Keywords

dentritic cell; immune checkpoint inhibitors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DC + ICI

Group Type: EXPERIMENTAL

dentritic cell infusion and immunecheckpoint inhibitor

Intervention Type: DRUG

dentritic cell infusion and immunecheckpoint inhibitor

Interventions

dentritic cell infusion and immunecheckpoint inhibitor

dentritic cell infusion and immunecheckpoint inhibitor

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soonchunhyang University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jong-Ho Won

Soonchunhyang University Seoul Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jong ho Won, MD, PhD

Role: CONTACT

Phone: +82 010-7303-1207

Email: jhwon@schmc.ac.kr

Other Identifiers

DC_ICI_PC_1

Identifier Type: -

Identifier Source: org_study_id