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Engineered immune cells take aim at Hard-to-Treat cancers

NCT ID NCT05877599

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 02, 2026 · Updated 6 times

Summary

This early-stage study tests a new treatment called NT-175 for people with advanced solid tumors (like lung, colon, or breast cancer) that have a specific mutation (TP53 R175H) and a certain immune marker (HLA-A*02:01). NT-175 is made from a patient's own immune cells, which are genetically modified to better recognize and attack cancer cells. The main goals are to check the treatment's safety and see if it can shrink tumors.

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 45 people

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

Started

Jul 2023

Expected to finish

Jul 2029

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 (Module 1) * Subjects must be at least 18 years of age * Subject must be diagnosed with one of the histologies below: * NSCLC * Colorectal adenocarcinoma * HNSCC * Pancreatic adenocarcinoma * Breast cancer * Ovarian cancer * Any other solid tumor * Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A\*02:01 positive (at least 1 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. * Subject has at least 1 measurable lesion * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Adequate hematological, renal, hepatic, pulmonary, and cardiac function Key Exclusion Criteria (Module 1) * Any another primary malignancy within the 3 years prior to enrollment * 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 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. * Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome. Key Inclusion Criteria (Module 2 - hematological malignancies) * At least 18 years of age * Diagnosis of AML or MDS that allows for efficacy assessments * Confirmation of TP53 R175H variant mutation in cancer cells * Subject must be HLA-A\*02:01 positive (at least 1 allele) * ECOG performance status of 0 to 1 Key Exclusion Criteria (Module 2 - hematological malignancy) * Acute promyelocytic leukaemia or isolated extramedullary disease * Another primary malignancy within 2 years (with exceptions) * HSCT within 100 days or immunosuppression for GvHD within 4 weeks * History of CNS or other extramedullary leukaemic involvement unless a lumbar puncture is negative for leukemic cells * Prior stroke, ischemic attack, significant cardiac disease, heart failure * Prior adoptive modified cell therapy * Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia breast cancer breast neoplasm cancer colorectal adenocarcinoma colorectal carcinoma colorectal neoplasm head and neck squamous cell carcinoma myelodysplastic syndrome myeloid neoplasm neoplasm non-small cell lung carcinoma ovarian cancer pancreatic adenocarcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Colorectal carcinoma Head and neck squamous cell carcinoma Myeloid neoplasms (AML/MDS) Non-small cell lung cancer Other solid tumors Ovarian cancer Pancreatic adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 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

    Gilbert, Arizona, 85234, United States

  • Research Site

    RECRUITING

    Duarte, California, 91010, United States

  • Research Site

    NOT_YET_RECRUITING

    Duarte, California, 91010, United States

  • Research Site

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • Research Site

    RECRUITING

    Newport Beach, California, 92663, United States

  • Research Site

    RECRUITING

    Santa Monica, California, 90404, United States

  • Research Site

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Research Site

    WITHDRAWN

    Miami, Florida, 33136, United States

  • Research Site

    WITHDRAWN

    Tampa, Florida, 33612, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Research Site

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Research Site

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Research Site

    RECRUITING

    New York, New York, 10065, United States

  • Research Site

    NOT_YET_RECRUITING

    New York, New York, 10065, United States

  • Research Site

    WITHDRAWN

    Charlotte, North Carolina, 28204, United States

  • Research Site

    WITHDRAWN

    Winston-Salem, North Carolina, 27103, United States

  • Research Site

    RECRUITING

    Portland, Oregon, 97213, United States

  • Research Site

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Research Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    RECRUITING

    Round Rock, Texas, 78665, United States

  • Research Site

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.