Study on EGFRBi Armed Fresh White Blood Cells for Advanced or Inoperable Pancreatic Cancer

Sponsor: University of Virginia

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06479239

Provider View

This clinical trial is testing a new treatment using modified white blood cells to help fight pancreatic cancer that has spread or cannot be removed by surgery. Participants will receive a series of infusions to see if this approach is safe and effective.

Patient Parameters

Program Overview

The aim of this study is to test the safety and effectiveness of a new treatment for pancreatic cancer that has returned or is not responding to other treatments. The treatment involves using a special type of white blood cell that has been modified to target cancer cells. Participants will receive these modified cells through an IV infusion once a week for 8 weeks, followed by additional doses every 2 weeks.

Description

In this study, participants will have their white blood cells collected through a process called leukapheresis. These cells are then modified in the lab to help them recognize and attack cancer cells. After about 72 hours, the modified cells are infused back into the participant's body. This process is repeated after 8-9 weeks, with additional infusions every 2 weeks for a total of 8 more doses. Throughout the study, blood samples will be taken to monitor the immune response and check the status of the cancer.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or inoperable pancreatic cancer that cannot be cured with surgery.
  • Have received at least one type of chemotherapy and have stable disease or better for 3 months before joining the study.
  • Have measurable cancer that can be tracked using standard criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Be 18 years or older.
  • Women of childbearing potential must have a negative pregnancy test before joining the study.
  • Agree to use effective birth control during the study and for 90 days after the last dose.
  • Have adequate organ function as shown by specific blood tests.
  • Be able to provide informed consent and agree to follow all study procedures.
  • Have adequate heart function with no recent heart attacks or severe heart conditions.

Exclusion Criteria

  • Have an allergy to cetuximab.
  • Have taken an experimental drug within 3 weeks before joining the study.
  • Have a serious wound, ulcer, or recent major surgery.
  • Have active liver disease, HIV, or active Hepatitis B or C.
  • Have an active infection or have taken antibiotics recently.
  • Have had a heart attack within the past year.
  • Have another cancer that could interfere with the study.
  • Have an autoimmune disease requiring treatment with steroids or immunosuppressants in the past 2 years.
  • Have any condition that could affect participation in the study.
  • Be currently breastfeeding.
  • Be unable to comply with study requirements.
  • Have a history of active tuberculosis.
  • Have received a live vaccine within 30 days before joining the study.
  • Be a prisoner or detained for treatment of a psychiatric or physical illness.

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