Immune cells armed with antibody take on pancreatic cancer
NCT ID NCT03269526
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial tested a new treatment called EGFR BATs for people with advanced pancreatic cancer. The treatment uses a patient's own immune cells, armed with a special antibody, to target cancer cells. The study included 22 participants who had already received chemotherapy. The goal was to check safety and see if it could improve survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EGFR BATs (immune cells armed with a bispecific antibody)
- What this could lead to
- If successful, this could offer a new treatment option to extend survival for people with advanced pancreatic cancer.
- What could go wrong
- This is an early-phase trial with only 22 participants, so results may not apply broadly. Side effects from the immune cells are possible.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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22 people
The number who actually took part.
- Started
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Jul 2017
- Finished
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Apr 2026
- 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
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18 years and older
- Sex
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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 Hide 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. Histological or cytological proof of pancreatic adenocarcinoma. Must have locally advanced or metastatic pancreatic cancer and received at least one dose of chemotherapy (any treatment line) and may have responding, stable or progressive disease 2. Expected survival ≥ 3 months 3. ECOG Performance Status 0 or 1 4. Left Ventricular Ejection Fraction (LVEF) ≥ 45% at rest (MUGA or Echo) 5. Age ≥ 18 years at the time of consent (Written informed consent and HIPAA authorization for release of personal health information) 6. Females of childbearing potential, and males, must be willing to use an effective method of contraception 7. Females of childbearing potential must have a negative pregnancy test within 10 days prior to "on study" status. If a urine or serum test is positive or cannot be confirmed as negative, the other (urine or serum pregnancy test, whichever was not performed first) will be required. 8. Demonstrate adequate hepatic, renal, and bone marrow function as defined below; all hematological, renal, and hepatic screening labs should be performed within 10 days prior to "on study" status (alpha gal testing must be within the regular screening period). * Absolute lymphocyte count ≥ 400/mm3 * Absolute neutrophil count (ANC) ≥ 1,000/mm3 * Platelets ≥ 75,000/mm3 * Hemoglobin ≥ 8 g/dL * Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) \< 2.0 mg/dl OR ≥50 ml/mm * Serum total bilirubin ≤ 2 mg/dl (biliary stent is allowed) * AST (SGOT) and ALT (SGPT) \< 5.0 times normal * Alpha 1,3 Galactose IgE ("alpha gal") \< 0.35 IU/ml or "negative" Exclusion Criteria: 1. Known hypersensitivity to cetuximab or other EGFR antibody 2. Treatment with any investigational agent within 14 days prior to first study intervention (apheresis) for protocol therapy 3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to first study intervention (apheresis). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 4. Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to "on-study" status 5. Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis 6. Is HIV positive or has evidence of active Hepatitis C virus or active Hepatitis B virus. If initial Hepatitis C test shows a positive result, the patient should have a Hepatitis viral load test to confirm. If initial HIV or Hepatitis B virus testing shows a positive result, no further testing will be done. 7. Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed) 8. Has an active infection requiring systemic therapy 9. A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy 10. Has a known history of active TB (Bacillus Tuberculosis) 11. Has had prior chemotherapy, radiation, hormonal, monoclonal antibody (mAb) or targeted small molecule therapy, within 2 weeks prior to the first study procedure (apheresis). Subjects who have not recovered to \<Grade 3 from an adverse event due to a previously administered agent are not eligible. 12. Has received a live vaccine within 30 days of first study procedure (apheresis). 13. History of a recent myocardial infarction (within one year), a past myocardial infarction (more than one year ago) along with current coronary symptoms requiring medications. 14. Has history of another malignancy within the past 5 years. Exceptions include * basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy * in situ cervical cancer. 15. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 17. Females must not be breastfeeding 18. Pt may be excluded if, in the opinion of the PI and investigator team, the pt is not capable of being compliant
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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.
Contacts and locations
Locations
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University of Virginia
Charlottesville, Virginia, 22903, United States
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