New immune cell therapy targets Hard-to-Treat cancers
NCT ID NCT06218914
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 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.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.
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.
-
The places running it
18 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGDuarte, California, 91010, United States
-
Research Site
RECRUITINGLos Angeles, California, 90095, United States
-
Research Site
RECRUITINGNewport Beach, California, 92663, United States
-
Research Site
RECRUITINGJacksonville, Florida, 32224, United States
-
Research Site
RECRUITINGChicago, Illinois, 60637, United States
-
Research Site
RECRUITINGWestwood, Kansas, 66205, United States
-
Research Site
RECRUITINGBoston, Massachusetts, 02115, United States
-
Research Site
RECRUITINGSt Louis, Missouri, 63110, United States
-
Research Site
RECRUITINGNew York, New York, 10016, United States
-
Research Site
RECRUITINGNew York, New York, 10065, United States
-
Research Site
RECRUITINGPortland, Oregon, 97213, United States
-
Research Site
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
-
Research Site
RECRUITINGPittsburgh, Pennsylvania, 15237, United States
-
Research Site
RECRUITINGNashville, Tennessee, 37203, United States
-
Research Site
RECRUITINGDallas, Texas, 75246, United States
-
Research Site
RECRUITINGGalveston, Texas, 77555, United States
-
Research Site
RECRUITINGHouston, Texas, 77030, United States
-
Research Site
RECRUITINGMilwaukee, Wisconsin, 53226, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Surgeons could freeze lung tumors from miles away using 5G robots
- Oral drug that targets two cancer drivers tested in first human study
- Can hormone pills replace chemo for aggressive endometrial cancer?
- Mitochondria-Targeting drug gamitrinib tested for first time in humans
- Can a Two-Drug combo outsmart advanced cancer?
- Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test