Clinical trial
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
Name
DC_ICI_PC_1
Description
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.
Trial arms
Trial start
2024-03-01
Estimated PCD
2024-12-31
Trial end
2025-12-31
Status
Not yet recruiting
Phase
Early phase I
Treatment
dentritic cell infusion and immunecheckpoint inhibitor
dentritic cell infusion and immunecheckpoint inhibitor
Arms:
DC + ICI
Size
10
Primary endpoint
treatment related adeverse event
for 1yr
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'dentritic cell + immunechekpoint inhibitor', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}
Updated at
2023-12-15
1 organization
1 product
1 indication
Organization
Soonchunhyang University HospitalIndication
Pancreatic Cancer