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New immune cell therapy targets Hard-to-Treat cancers

NCT ID NCT06218914

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 25, 2026 · Updated 7 times

Summary

This early-stage trial tests a new type of immunotherapy where a patient's own T cells are genetically engineered to recognize and attack cancer cells with a specific KRAS G12D mutation. The study includes adults with advanced lung, colorectal, pancreatic, or endometrial cancers that have not responded to standard treatments. The main goals are to check safety and find the right dose, while also looking for signs of tumor shrinkage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
engineered T cells (NT-112 and AZD0240) targeting KRAS G12D mutation
What this could lead to
If successful, this could lead to a new treatment option for people with advanced cancers that have a specific KRAS mutation, potentially shrinking tumors or slowing disease progression.
What could go wrong
This is a very early (Phase 1) trial with only 108 participants, so safety and effectiveness are not yet proven. The treatment may cause serious side effects, and it only works for people with a specific genetic profile (KRAS G12D and certain HLA types).

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 108 people

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

Started

Mar 2024

Expected to finish

Nov 2043

An estimate. End dates often move.

Lead sponsor

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

18 years and older

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.

Key Inclusion Criteria: * Age ≥18 years * Diagnosed with NSCLC, Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Endometrial Cancer or any other solid tumor * Tumors must harbor a KRAS G12D variant mutation and subject must be HLA-C\*08:02 positive, HLA-A\*11:01 or HLA-A\*11:02 positive in at least one allele * Subject has advanced solid cancer, defined as unresectable, advanced, and/or metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options. * Presence of at least 1 measurable lesion per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment Key Exclusion Criteria: * Any other primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer * Known, active primary central nervous system (CNS) malignancy * History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation. * History of stroke or transient ischemic attack within the 12 months prior to enrollment. * History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment. * Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment. * Any form of primary immunodeficiency. * Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy) * Female of childbearing potential who is lactating or breast feeding at the time of enrollment * Prior treatment with pan-KRAS or KRAS G12D targeting agents unless presence of KRAS G12D mutation is confirmed after the completion of treatment with pan-KRAS or KRAS G12D targeting 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

    18 sites. 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

  • Research Site

    RECRUITING

    Duarte, California, 91010, United States

  • Research Site

    RECRUITING

    Los Angeles, California, 90095, United States

  • Research Site

    RECRUITING

    Newport Beach, California, 92663, United States

  • Research Site

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Research Site

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Research Site

    RECRUITING

    Westwood, Kansas, 66205, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Research Site

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Research Site

    RECRUITING

    New York, New York, 10016, United States

  • Research Site

    RECRUITING

    New York, New York, 10065, United States

  • Research Site

    RECRUITING

    Portland, Oregon, 97213, United States

  • Research Site

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Research Site

    RECRUITING

    Pittsburgh, Pennsylvania, 15237, United States

  • Research Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Research Site

    RECRUITING

    Dallas, Texas, 75246, United States

  • Research Site

    RECRUITING

    Galveston, Texas, 77555, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

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