for people ages 18 years and up (full criteria)
study started
completion around



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 solid tumors.

Official Title

An Open-label, Phase 1, Multicenter Study to Evaluate the Safety and Preliminary Anti-tumor Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Subjects With Unresectable, Advanced and/or Metastatic Solid Tumors That Are Positive for the TP53 R175H Mutation


This is a Phase 1, open-label, multicenter study to evaluate the safety and preliminary antitumor activity of NT-175 in HLA-A*02:01 subjects with unresectable, advanced, and/or metastatic NSCLC, colorectal adenocarcinoma, HNSCC, pancreatic adenocarcinoma, breast cancer, or any other solid tumor histologies that are positive for the TP53 R175H mutation.


Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Carcinoma, Pancreatic Adenocarcinoma, Breast Cancer, Other Solid Tumors, Carcinoma, Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms, Autologous, engineered T Cells targeting TP53 R175H


You can join if…

Open to people ages 18 years and up

  • Subjects must be at least 18 years of age, at the time of signing the informed consent.
  • Subjects must be capable of giving signed informed consent.
  • Subject must be diagnosed with one of the histologies below:
  • Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A*02:01 positive (at least 1 allele) as confirmed by an CLIA-accredited laboratory-based test.
  • 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 per computed tomography (CT) scan or magnetic resonance imaging (MRI).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment
  • Adequate hematological, renal, hepatic, pulmonary, and cardiac function
  • Per Investigator judgement, subject is likely to complete study visits and/or procedures per the protocol and comply with study requirements for study participation

You CAN'T join if...

  • Any another 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.
  • History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or rIL-2; or known sensitivity or allergy to methotrexate, gentamicin, or other aminoglycosides.
  • Any form of primary immunodeficiency.
  • Live vaccine ≤ 4 weeks prior to enrollment or plans to have a live vaccine prior to planned lymphodepleting chemotherapy and/or NT-175 treatment.
  • 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.
  • Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.


  • University of California, Los Angeles (UCLA) accepting new patients
    Los Angeles California 90095 United States
  • Hoag Medical Group accepting new patients
    Newport Beach California 92663 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States


accepting new patients
Start Date
Completion Date
Neogene Therapeutics, Inc.
Phase 1 research study
Study Type
Expecting 24 study participants
Last Updated