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Engineered immune cells take on Hard-to-Treat pancreatic cancer

NCT ID NCT04146298

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests a personalized cell therapy for advanced pancreatic cancer. Patients receive their own immune cells that have been engineered to recognize and attack cancer cells with a specific mutation (KRAS G12V). The study enrolls 30 people whose tumors carry this mutation and a specific immune type (HLA-A*11:01). 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
Mutant KRAS G12V-specific TCR transduced autologous T cells
What this could lead to
If it works, this could point toward a new treatment option for advanced pancreatic cancer patients with the KRAS G12V mutation.
What could go wrong
This is an early-phase trial with only 30 participants, so results may not apply to everyone. There are risks of serious side effects from the chemotherapy and cell infusion.

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 30 people

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

Started

Oct 2021

Expected to finish

Dec 2028

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 to 75 years

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: * Patients with measurable and pathologically confirmed advanced pancreatic cancer, including metastatic pancreatic cancer (who have received standard chemotherapy) and recurrent pancreatic cancer (who have received surgery and adjuvant chemotherapy previously). * Patient's tumor must express the KRAS G12V mutation, or a G12V mutation in HRAS or NRAS, as determined by DNA or RNA sequencing methods. * Patients must be HLA-A\*11:01. * Patients with brain metastasis may be eligible if they are asymptomatic and there are fewer than 3 brain lesions that are each less than 1 cm in diameter. * Patients between 18 to 75 years old are eligible. * Patients should have good clinical performance status (ECOG 0 or 1). * Patients must practice birth control once enrolled into the study and for up to four months after therapy. * Patients must be seronegative for HIV antibody. * Patients must be seronegative for hepatitis B surface antigen and core antibody (or HBV non-detectable by QPCR). * Patients must be seronegative for hepatitis C antibody (or HCV non-detectable by QPCR). * Baseline hematology criteria: * Absolute neutrophil count of at least 1000/mm\^3. * White blood cell count of at least 3000/mm\^3. * Platelet count of at least 100,000/mm\^3. * Hemoglobin \> 8.0 g/dL. * Baseline chemistry criteria: * Serum ALT/AST less than or equal to 3.0 x ULN. * Total bilirubin less than or equal to 1.5 mg/dL, unless the patient has Gilbert's Syndrome in which case total bilirubin must be less than or equal to 3.0 mg/dL. * Serum creatinine less than or equal to 1.6 mg/dL. * Anticipated lifespan greater than 12 weeks. * Patients must be willing and able to comply with all study-related procedures and follow-up requirements. * Patients must be able to understand and sign a written Informed Consent Document as well as a durable power of attorney. Exclusion Criteria: * Women who are pregnant or breastfeeding. * Patients with any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or HIV). * Patients with active systemic infections, coagulation disorders, or any other major medical illnesses. * Patients with concurrent opportunistic infections. * Patients on concurrent systemic steroid therapy. * Patients with a history of severe immediate hypersensitivity reaction to any of the medicines used in this study (e.g., cyclophosphamide, fludarabine). * Patients with active coronary ischemic symptoms. * Patients who are receiving any other investigational agents.

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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

  • Changhai Hospital

    RECRUITING

    Shanghai, 200433, China

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