Immune cells armed to fight pancreatic cancer: a new hope?
NCT ID NCT04137536
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new treatment called EGFR-BATs for people with advanced pancreatic cancer that has not responded to standard chemotherapy. The treatment uses the patient's own immune cells, which are trained in a lab to better attack cancer cells. The main goal is to find the safest dose and understand possible side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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7 people
The number who actually took part.
- Started
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Oct 2019
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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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: * Histological or cytological proof of pancreatic adenocarcinoma. Must have metastatic pancreatic cancer who have received at least first line chemotherapy. Disease stability or progression during or within 6 months after treatment with 5-Fluorouracil (5-FU)- or gemcitabine-based chemotherapy. KPS\>/= 70% or SWOG performance Status 0 or 1 * Evaluable disease by iRECIST criteria * Absolute Neutrophil Count (ANC) \>/= 1,000/mm\^3 * Lymphocyte count \>/= 400/mm\^3 * Platelet Count \>/= 75,000/mm\^3 * Hemoglobin \>/= 8 g/dL * Serum Creatinine \< 2.0 mg/dl, Creatinine Clearance \>/=50 ml/mm (can be calculated or measured) * Total Bilirubin \</= 2 mg/dl (biliary stent is allowed) * SGPT and SGOT \<5.0 times normal * LVEF \>/= 55% at rest (\<UGA or Echo) * Age \>/= 18 years at the time of consent (Written informed consent and HIPAA authorization for release of personal health information) * Females of childbearing potential, and males, must be willing to use an effective method of contraception * Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy Exclusion Criteria: * Any chemotherapy related toxicities from prior treatment, \> grade 2 per CTCAE v4.0 * Known hypersensitivity to cetuximab or other EGFR antibody * Treatment with any investigational agent within 14 days prior to being registered for protocol therapy * Symptomatic brain metastasis * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Steroid premedication for imaging scans is allowed. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to being registered for protocol therapy * Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis * Known HIV infection * Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed) * Has an active infection requiring systemic therapy * A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy. * Females must not be breastfeeding * Patient may be excluded if, in the opinion of the PI and investigator team, the patient 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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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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University of Virginia (Specimen Analysis)
Charlottesville, Virginia, 22908, United States
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Other studies related to the condition(s) this trial covers.
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