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

NCT06172634 | Unknown Phase 1

• 1 other identifier: DC_ICI_PC_1
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreas Cancer

Keywords

dentritic cell; immune checkpoint inhibitors

Outcome Measures

Primary Outcomes (1)

• treatment related adeverse event

  for 1yr

Secondary Outcomes (1)

• overall response rate

  for 1yr

Study Arms (1)

DC + ICI

EXPERIMENTAL

Drug: dentritic cell infusion and immunecheckpoint inhibitor

Interventions

dentritic cell infusion and immunecheckpoint inhibitor DRUG

dentritic cell infusion and immunecheckpoint inhibitor

DC + ICI

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Jong ho Won, MD, PhD

CONTACT

+82 010-7303-1207; jhwon@schmc.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Soonchunhyang University Seoul Hospital

Model Details: dentritic cell + immunechekpoint inhibitor

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 15, 2023

Record last verified: 2023-12