Study of EGFR FPBMC for Metastatic or Unresectable Pancreatic Cancer

This study is looking at a new treatment called EGFR FPBMC for people with pancreatic cancer that has spread (metastatic) or cannot be removed by surgery (unresectable). You might be able to join if you've already had at least one type of chemotherapy and your cancer has been stable for at least three months. The main goal is to see how safe EGFR FPBMC is, especially looking for any serious side effects during the first eight infusions. Researchers also want to get an idea of how well it works. EGFR FPBMC is a type of immunotherapy that uses your own white blood cells, specifically T cells, to target and kill cancer cells that have a marker called EGFR. The study plans to enroll 23 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 23 participants, but the phase of the study is not specified.
What's involved
You would have a procedure called leukapheresis to collect your white blood cells. Then, you would receive 8 infusions of EGFR FPBMC twice a week, followed by another leukapheresis and 8 more infusions every two weeks. Blood samples will be collected before, during, and after treatment, and your disease status will be checked regularly.
Compensation
Not stated in the trial record.
Follow-up
Disease status will be checked regularly during and after study treatment. Dose-limiting toxicities will be measured about 4 weeks after starting treatment.

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NCT06479239

Study of EGFRBi Armed Fresh PBMC in Metastatic or Unresectable Pancreatic Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Virginia
~23 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:EGFR FPBMC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicities (DLTs) during the dose escalation phase (during the first 8 infusions only)
Measured over Through the dose escalation phase (during the first 8 infusions only, about 4 weeks after starting study treatment))
Pancreas Cancer
Pancreatic Cancer
1 sites across 1 states
Virginia1
  • Tri Le, MD, DSc · PRINCIPAL_INVESTIGATOR · University of Virginia

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Eligibility criteria

Inclusion

Absolute neutrophil count \>= 500/mm3
Absolute lymphocyte count \>= 400/mm3
Platelets \>= 75,000/mm3
Hemoglobin \>= 8 g/dL
Serum creatinine \< 2.0mg/dL or calculated/measured creatinine clearance \>= 50 ml/min
Bilirubin \<= 2 mg/dL
Aspartate transferase (AST) and Alanine transaminase (ALT) \<= 5.0 x upper limit of normal (ULN)
Alpha gal \< 0.35 IU/ml or "negative" 9. Ability to provide informed consent and provision of written informed consent 10. Stated willingness to comply with all study procedures and availability for the duration of the study 11. Adequate cardiac function as defined as:
No uncontrolled angina or severe ventricular arrhythmias
No clinically significant pericardial disease
No history of myocardial infarction (MI) in the last year before registration
No Class 3 or higher New York Heart Association Congestive Heart Failure
  • Dose limiting toxicities (DLTs) during the dose escalation phase (during the first 8 infusions only)Through the dose escalation phase (during the first 8 infusions only, about 4 weeks after starting study treatment))

    As defined in the protocol