RecruitingPhase 1

A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation

An Open-label, Phase 1, Multicentre Platform Study to Evaluate the Safety and Preliminary Anti-tumour Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Participants With Advanced Malignancies That Are Positive for the TP53 R175H Mutation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests NT-175, a treatment made from a person's own T cells, which are immune cells changed to target cancer. It is for adults with advanced solid tumors or certain blood cancers whose cancer has the TP53 R175H gene change and who have the HLA-A*02:01 immune system marker.

Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: Be at least 18 years old.
  • Both groups: Cancer cells must have the TP53 R175H gene change, and you must have the HLA-A*02:01 immune system marker.
  • Both groups: Be fully active or able to do light work, with only limits on harder activity.
  • Solid tumor group: Have lung, colon or rectal, head and neck, pancreatic, breast, ovarian, or another solid cancer.
  • Solid tumor group: Have advanced stage III or IV cancer that cannot be removed by surgery and/or has spread. You must have had at least one approved standard drug treatment, with no treatment available that could cure the cancer.
  • Solid tumor group: Have at least one tumor that can be measured.
  • Solid tumor group: Have good enough blood counts and kidney, liver, lung, and heart function.
  • Blood cancer group: Have acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), a blood and bone marrow cancer, that doctors can assess for treatment response.

Who can't join

  • Both groups: You or a relative has Li-Fraumeni syndrome, an inherited condition that raises cancer risk.
  • Other cancers: For the solid tumor group, another separate cancer within 3 years or active cancer that started in the brain or spinal cord. For the blood cancer group, another separate cancer within 2 years, with some exceptions.
  • Past treatments: For the solid tumor group, prior cell and gene therapy, a stem cell transplant from a donor, or an organ transplant. For the blood cancer group, prior treatment with modified immune cells.
  • Heart and blood vessel problems: For the solid tumor group, serious heart disease within 6 months or heart failure at any time. For the blood cancer group, prior stroke, a brief loss of blood flow to the brain, serious heart disease, or heart failure.
  • Solid tumor group: Recent treatment that acts throughout the body, within 2 weeks or 3 drug half-lives, whichever is shorter. A half-life is the time the body takes to clear half a drug. An immune weakness you were born with also excludes you.
  • Blood cancer group: Acute promyelocytic leukemia, a type of AML, or disease found only outside the bone marrow.
  • Blood cancer group: A stem cell transplant within 100 days, or immune-suppressing medicine within 4 weeks for graft-versus-host disease, when donor cells attack your body.
  • Blood cancer group: Past leukemia in the brain, spinal cord, or other areas outside the bone marrow, unless a spinal fluid test shows no leukemia cells.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (20)

AZ

CA

FL

MA

NC

NJ

NY

OR

PA

TN

TX

WI