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临床试验/NCT06172634
NCT06172634尚未招募1 期

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

Soonchunhyang University Hospital0 个研究点目标入组 10 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
10
主要终点
treatment related adeverse event

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

DC + ICI

Experimental

干预措施: dentritic cell infusion and immunecheckpoint inhibitor (Drug)

结局指标

主要结局

treatment related adeverse event

时间窗: for 1yr

次要结局

  • overall response rate(for 1yr)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jong-Ho Won

Soonchunhyang University Seoul Hospital

Soonchunhyang University Hospital

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