RecruitingPhase 1Phase 2NCT06479239

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

Phase I/II Study of Anti-CD3 x Anti-EGFR Bispecific Antibody (EGFRBi) Armed Fresh Peripheral Blood Mononuclear Cells (EGFR FPBMC) in Metastatic or Unresectable Pancreatic Cancer


Sponsor

University of Virginia

Enrollment

23 participants

Start Date

Nov 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to understand the safety and estimate the efficacy of combining anti-cluster of differentiation 3 (CD3) x anti-Epidermal Growth Factor Receptor (EGFR) bispecific antibody fresh peripheral blood mononuclear cells (EGFR FPBMC) for patients with metastatic or unresectable pancreas cancer. Participants receive 8 twice weekly doses and then 8 more doses every 2 weeks of EGFR FPBMC by intravenous infusion.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests EGFRBi-Armed T cells — a type of immune cell therapy where a patient's own white blood cells are coated with a special molecule that helps them target and kill pancreatic cancer cells — in patients with advanced or metastatic pancreatic cancer. **You may be eligible if...** - You have confirmed locally advanced or metastatic pancreatic cancer that cannot be cured with surgery or other local treatments - You have already received at least one chemotherapy regimen (gemcitabine, 5FU-based, or paclitaxel-based) and your disease has been stable for 3+ months - You have measurable disease on imaging **You may NOT be eligible if...** - You have not received any prior chemotherapy - Your disease is progressing rapidly (not stable on imaging) - You have significant organ problems or active infection - Your cancer has specific mutations (e.g., BRCA, KRAS) where approved targeted therapies exist but you haven't tried them Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEGFR FPBMC

Participants will receive 8 twice weekly infusions of EGFR FPBMC, then 8 additional infusions every 2 weeks.


Locations(1)

University of Virginia

Charlottesville, Virginia, United States

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NCT06479239


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