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Experimental immune therapy takes on tough pancreatic cancer

NCT ID NCT06479239

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new treatment called EGFR FPBMC for people with advanced pancreatic cancer that cannot be removed by surgery or has spread. The treatment uses a patient's own immune cells, which are modified in the lab to better attack cancer cells, then given back through an IV. The goal is to see if it is safe and if it can shrink tumors or slow the disease. The trial is recruiting 23 participants at the University of Virginia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EGFR FPBMC (a type of immune cell therapy that targets cancer cells)
What this could lead to
If it works, this could offer a new treatment option for people with advanced pancreatic cancer that has not responded to standard chemotherapy.
What could go wrong
This is an early-phase trial with only 23 participants, so the results may not apply to everyone. The treatment may cause side effects or not shrink tumors as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 23 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed locally advanced pancreatic cancer (LAPC)/unresectable pancreatic cancer (UPC) or metastatic pancreatic cancer (MPC) not eligible for curative intent therapy 2. Received at least 1 line of chemotherapy and have stable disease (SD) or better for 3 months prior to enrollment. Therapy should consist of either a gemcitabine, 5FU-based (including capecitabine) or albumin-bound paclitaxel-based regimen. Patients with actionable mutations should have received targeted therapy prior to enrollment on trial. Patients who qualify for immunotherapy due to mismatch repair protein/microsatellite stable and tumor mutational burden status should also have received immunotherapy prior to enrollment on trial. 3. Measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 5. Age ≥ 18 years 6. Females of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment/registration 7. Females of childbearing potential and males must agree to use an effective method for contraception for the duration of the treatment with study drug plus 90 days (duration of sperm turnover). Males must also abstain from sperm donations during study treatment and for at least 90 days after the last dose of study drug. 8. Adequate organ function within 14 days prior to registration, defined as the following: * 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 Exclusion Criteria: 1. Known hypersensitivity to cetuximab 2. Treatment with investigational agent within 3 weeks prior to registration 3. Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration 4. Known active liver disease, human immunodeficiency virus (HIV)+ or evidence of active Hepatitis C or B virus; bleeding or condition associated with high-risk bleeding (anticoagulation is allowed) 5. Active infection; prior antibiotic/antifungal/antiviral therapies within 2 weeks prior to registration 6. History of a myocardial infarction within 1 year prior to registration 7. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial 8. Autoimmune disease that has required systemic treatment with chronic steroids or immunosuppressive therapy in the 2 years prior to registration (thyroxine, insulin, or corticosteroid replacement is allowed) 9. History or evidence of any condition that might confound the results of the trial, interfere with the subject's participation, or is not in the best interest of the subject to participate, in the opinion of the treating investigator 10. Females must not be currently breast feeding. 11. The treating investigator feels the patient is not able to be compliant. 12. History of active Bacillus Tuberculosis (TB). 13. Has received a live vaccine within 30 days of registration. 14. Prisoners or patients who are incarcerated. 15. Patients who are compulsorily detained for treatment of a psychiatric or physical illness.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

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