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 Overview

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

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.

Pancreas Cancer

DRUG: dentritic cell infusion and immunecheckpoint inhibitor

DC_ICI_PC_1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-12-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-12-07
First Submitted that Met QC Criteria 2023-12-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-12-15
First Posted (ACTUAL) 2023-12-15	Results First Posted N/A	Last Verified 2023-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: DC + ICI	DRUG: dentritic cell infusion and immunecheckpoint inhibitor dentritic cell infusion and immunecheckpoint inhibitor

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: DC + ICI

DRUG: dentritic cell infusion and immunecheckpoint inhibitor

dentritic cell infusion and immunecheckpoint inhibitor

Primary Outcome Measures	Measure Description	Time Frame
treatment related adeverse event		for 1yr

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jong ho Won, MD, PhD

Phone Number: +82 010-7303-1207

Email: jhwon@schmc.ac.kr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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Clinical Trial Record