Study on BATs Treatment for Pancreatic Cancer, Phase Ib/II

Sponsor: University of Virginia

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03269526

Provider View

This clinical trial is testing a new treatment using specially modified T cells, called EGFR BATs, to help fight pancreatic cancer that has spread or is locally advanced. The study aims to confirm the safety and effectiveness of this treatment in patients who have already received some chemotherapy.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment for pancreatic cancer using EGFR BATs, which are specially modified T cells. These cells are designed to target and attack cancer cells in patients with advanced pancreatic cancer who have already received chemotherapy. The study will first confirm a safe dose of the treatment in a small group of patients, and then test its effectiveness in a larger group.

Description

Once patients are eligible, their white blood cells are collected through a procedure called leukapheresis about 3 to 4 weeks before the first infusion of EGFR BATs. These white blood cells, specifically T cells, are then activated and modified in the lab to create EGFR BATs. The modified cells are frozen and stored until they are ready to be infused.

Before the infusion of EGFR BATs, patients will receive one dose of chemotherapy, chosen by their doctor. About 4 weeks after the leukapheresis procedure, patients will start receiving the EGFR BATs infusions. Depending on when they join the study, they will receive either eight infusions twice a week or four infusions once a week over a four-week period. The total dose is the same for both groups.

Patients will have follow-up visits at 1 to 2 weeks, 4 to 5 weeks, 2 months, 4 months, and 6 months after the last infusion to monitor their health and the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of pancreatic adenocarcinoma that is locally advanced or has spread, and have received at least one dose of chemotherapy.
  • Expected to live at least 3 more months.
  • 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.
  • Have a heart function with an ejection fraction of 45% or higher.
  • Be 18 years or older.
  • Agree to use effective contraception if of childbearing potential.
  • Women must have a negative pregnancy test before starting the study.
  • Have adequate liver, kidney, and bone marrow function as shown by specific blood tests.

Exclusion Criteria

  • Allergic to cetuximab or other EGFR antibodies.
  • Have taken any investigational drugs within 14 days before starting the study.
  • Have an immune deficiency or are on long-term steroid or immunosuppressive therapy.
  • Have serious wounds, fractures, or recent major surgery.
  • Have active liver disease or infections like HIV, Hepatitis B, or Hepatitis C.
  • Have a high risk of bleeding or active infections.
  • Have uncontrolled medical conditions that could be worsened by the study treatment.
  • Have a history of tuberculosis or recent cancer treatments.
  • Have received a live vaccine within 30 days before starting the study.
  • Have had a recent heart attack or ongoing heart issues.
  • Have had another cancer in the past 5 years, except for certain skin or cervical cancers.
  • Have active autoimmune diseases requiring treatment in the past 2 years.
  • Are pregnant, breastfeeding, or unable to comply with study requirements.

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