Can a Patient's own immune cells be trained to fight pancreatic cancer?
NCT ID NCT04157127
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing whether a personalized vaccine made from a patient's own immune cells, combined with standard chemotherapy, is safe and feasible for treating pancreatic cancer after surgical removal. The vaccine is designed to train the immune system to recognize and attack any remaining cancer cells. The study involves 18 adults with pancreatic adenocarcinoma or adenosquamous carcinoma who have had surgery, and it aims to measure safety, side effects, and how well the vaccine can be delivered.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Autologous dendritic cell therapy (a personalized vaccine made from the patient's own immune cells, loaded with pancreatic cancer proteins and mRNA)
- What this could lead to
- If successful, this approach could offer a new way to reduce the risk of pancreatic cancer returning after surgery, potentially improving long-term survival.
- What could go wrong
- This is an early, small phase 1 trial focused on safety and feasibility, so it may not prove effective. There are risks of immune-related side effects, and the therapy may not work for everyone.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2020
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 An individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Male or female, aged 18 years and older 3. Cytological or pathological confirmation of adenocarcinoma or adenosquamous carcinoma of the pancreas is deemed to be potentially resectable or borderline resectable based on tumor and host factors. This may include patients who undergo upfront resection or those who receive neoadjuvant chemotherapy +/- radiation prior to resection. 4. Adequate kidney, liver, bone marrow function, and immune function, as follows, within 28 days prior to registration: 1. Hemoglobin ≥ 8.0 gm/dL 2. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 3. Platelet count ≥ 75,000 /mm3 4. Total bilirubin ≤ 1.5 times upper limit of normal (ULN), 5. Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 2.5 times the ULN 5. ECOG performance status ≤ 2. 6. For women of childbearing potential (WOCBP): use of highly effective contraception must be discussed with participants. NOTE: Patient must agree to start contraception at least 30 days before first vaccination and continue for at least 12 weeks after her last vaccination. 7. WOCBP must have a negative serum pregnancy prior to vaccination 8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 12 weeks following discontinuations of last vaccination. 9. Patient must agree to not donate blood for up to 90 days after last vaccination. Exclusion Criteria An individual who meets any of the following criteria will be excluded from participation in this study: 1. Unresectable or metastatic (stage IV) pancreatic cancer. 2. Patients with known HIV and a positive viral load. 3. Patients with active HBV and HCV infection. Those who are Hepatitis B sAb positive as well as those who are Hepatitis C Ab positive, but Hepatitis C RNA viral load negative will not be excluded. 4. Patients with any active autoimmune disease or immune deficiency or previous Guillain-Barre syndrome. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g. patient with psoriatic arthritis are excluded) are eligible provided all of the following conditions are met: 1. Rash that covers less than 10 % of body surface area. 2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids. 3. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months. 5. Use of nonstandard neoadjuvant chemotherapy regimen, as determined by the Investigator. 6. Female patients who are pregnant, breastfeeding, or of childbearing potential without a negative pregnancy test within 28 days (or decline contraception requirements as outlined above). Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. 7. Patients unwilling or unable to comply with the protocol or provide informed consent. 8. Any severe or uncontrolled medical condition or other condition that could affect participation in this study (in the opinion of the investigator), including but not limited to hyper/hypothyroidism, active systemic autoimmune disorders, untreated viral hepatitis or autoimmune hepatitis. 9. Requires chronic treatment with a systemic steroid (⩾10 mg/day of prednisone equivalent) or with any systemic immunosuppressive agent.
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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.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Baylor College of Medicine Medical Center - McNair Campus
RECRUITINGHouston, Texas, 77030, United States
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Baylor St. Lukes Medical Center
RECRUITINGHouston, Texas, 77030, United States
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Dan L. Duncan Cancer Center at Baylor College of Medicine
RECRUITINGHouston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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- Can a new drug shrink advanced solid tumors?
- Can genes and environment together trigger pancreatic disease? a new biobank seeks answers
- Can protein patterns in stored tumors point to new treatment targets?
- Can a triple therapy shrink pancreatic tumors enough for complete surgery?