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

Pancreas Cancer Clinical Trial

— DICI_PC  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06172634
• Other study ID #: DC_ICI_PC_1
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: March 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Soonchunhyang University Hospital
• Contact: Jong ho Won, MD, PhD
• Phone: +82 010-7303-1207
• Email: jhwon[@]schmc.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• dentritic cell infusion and immunecheckpoint inhibitor
dentritic cell infusion and immunecheckpoint inhibitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment related adeverse event		for 1yr
Secondary	overall response rate	treatment response	for 1yr