Supercharged immune cells take on Hard-to-Treat pancreatic cancer
NCT ID NCT07145450
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new therapy that takes a patient's own immune T-cells, engineers them to recognize and attack pancreatic cancer cells with specific KRAS mutations, and infuses them back. The study includes 96 adults with advanced pancreatic cancer who have the right genetic markers. The goal is to see if the treatment is safe and can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TCR-T cells (engineered immune cells targeting mutated KRAS proteins)
- What this could lead to
- If successful, this could lead to a new treatment option for advanced pancreatic cancer by training the immune system to attack cancer cells with specific mutations.
- What could go wrong
- This is an early first-in-human trial, so safety and effectiveness are not yet known. The therapy requires chemotherapy beforehand and may cause serious side effects. Only patients with specific genetic profiles can participate.
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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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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: 1. Adult patient (18 years or older) with newly diagnosed metastatic PDAC or locally advance PDAC disease. 2. HLA genotyping confirmed with a high-resolution method. 3. Confirmed KRAS G12V or KRAS G12D mutation in tumour using biopsy sample. 4. Fertile male and female patients must use a highly effective contraceptive method before, during, and for at least 6 months after the last mutKRAS TCR infusion. Acceptable contraception for women includes implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence, or a partner who has been vasectomized for at least 6 months. Acceptable contraception for male includes having had a vasectomy for at least 6 months, sexual abstinence, to condoms plus spermicide. Fertile female and male patients must adhere to any treatment-specific pregnancy prevention guidelines for cyclophosphamide (refer to SmPC). 5. Confirmed clinical benefit to SoC treatments and absence of disease progression according to the PI judgement. 6. Measurable disease by RECIST 1.1 criteria at the time of first treatment. Baseline imaging (for example, diagnostic CT of chest/abdomen/pelvis and imaging of the affected extremity or brain, as appropriate), or magnetic resonance imaging (MRI) must be obtained within 8 weeks of the first planned T cell infusion. CT can be substituted for MRI in patients unable to have CT contrast. Exclusion Criteria: 1. Another malignancy other than PDAC. 2. Current or history of brain metastasis. 3. Patient with known genetic status for whom other treatments are available e.g. BRCA, MSI-H.
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Genom att skicka in godkänner du våra Användarvillkor
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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
10 sites in 4 countries. 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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Amsterdam UMC - VU Medical Center
RECRUITINGAmsterdam, Netherlands
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Charité Universitätsmedizin Berlin
RECRUITINGBerlin, Germany
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Herlev and Gentofte University Hospital
RECRUITINGCopenhagen, Denmark
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Karolinska University Hospital
RECRUITINGStockholm, Sweden
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Ludwig-Maximilians-Universitaet Muenchen (LMU) Klinikum der Universitaet Muenchen - Campus Grosshadern - Medizinische Klinik und Poliklinik III
NOT_YET_RECRUITINGMünchen, Germany
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Radboud University Medical Center
RECRUITINGNijmegen, Netherlands
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Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus
RECRUITINGDresden, Germany
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Universitaetsklinikum Heidelberg
RECRUITINGHeidelberg, Germany
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Universitaetsklinikum Leipzig - Universitaeren Krebszentrum (UCCL)
NOT_YET_RECRUITINGLeipzig, Germany
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University Hospital and Faculty of Medicine Eberhard Karls University Tübingen
RECRUITINGTübingen, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug candidate takes aim at Hard-to-Treat pancreatic cancer
- Can a pill duo outsmart a Hard-to-Treat pancreatic cancer mutation?
- Can a Two-Drug combo tame Hard-to-Treat pancreatic cancer?
- Can a One-Two punch of radiation and immunotherapy tame pancreatic cancer?
- Can an immunotherapy cocktail slow pancreatic cancer? a new trial aims to find out.
- Smart drug delivers chemo directly to pancreatic cancer cells