Actively Recruiting
Study of EGFRBi Armed Fresh PBMC in Metastatic or Unresectable Pancreatic Cancer
Led by University of Virginia · Updated on 2026-03-13
23
Participants Needed
1
Research Sites
342 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of EGFRBi Armed Fresh PBMC in Metastatic or Unresectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed locally advanced, unresectable, or metastatic pancreatic cancer not eligible for curative therapy
- Received at least one line of chemotherapy with stable disease or better for 3 months prior to enrollment
- Chemotherapy regimens include gemcitabine, 5FU-based, capecitabine, or albumin-bound paclitaxel based
- Patients with actionable mutations must have received targeted therapy before enrollment
- Patients eligible for immunotherapy must have received it prior to enrollment
- Measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Age 18 years or older
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment
- Both females of childbearing potential and males must agree to use effective contraception during treatment and for 90 days after
- Males must abstain from sperm donation during treatment and for 90 days after last dose
- Adequate organ function within 14 days prior to registration as defined by specific blood count and chemistry values
- Ability to provide informed consent
- Willingness to comply with study procedures and availability for the study duration
- Adequate cardiac function: no uncontrolled angina, severe arrhythmias, significant pericardial disease, recent myocardial infarction, or severe heart failure
You will not qualify if you...
- Known allergy to cetuximab
- Treatment with investigational agents within 3 weeks prior to registration
- Serious non-healing wounds, ulcers, fractures, major surgery, open biopsy, or major injury within 28 days prior to registration
- Active liver disease, HIV, active Hepatitis B or C, or high-risk bleeding conditions
- Active infection or recent antibiotic, antifungal, or antiviral therapy within 2 weeks prior to registration
- Myocardial infarction within 1 year prior to registration
- Autoimmune disease needing chronic steroid or immunosuppressive treatment in past 2 years
- Conditions that could interfere with study results or participation as judged by the investigator
- Currently breastfeeding females
- History of active tuberculosis
- Receipt of live vaccine within 30 days prior to registration
- Prisoners or incarcerated individuals
- Patients detained for psychiatric or physical illness treatment against their will
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
A
Ashley Donihee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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