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NCT05877599 | Recruiting | Non-small Cell Lung Cancer

A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation
Sponsor:

Neogene Therapeutics, Inc.

Brief Summary:

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.

Condition or disease

Non-small Cell Lung Cancer

Head and Neck Squamous Cell Carcinoma

Colorectal Carcinoma

Pancreatic Adenocarcinoma

Breast Cancer

Other Solid Tumors

Intervention/treatment

Autologous, engineered T Cells targeting TP53 R175H

Phase

Phase 1

Detailed Description:

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.}}

Study Type : Interventional
Estimated Enrollment : 24 participants
Masking : None (Open Label)
Primary Purpose : Treatment
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
Actual Study Start Date : July 27, 2023
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : August 2039
Arm Intervention/treatment

Experimental: Dose Escalation

Dose Escalation of TCR T cell product

Biological: Autologous, engineered T Cells targeting TP53 R175H
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Key Inclusion Criteria
  • 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
    • NSCLC
    • Colorectal adenocarcinoma
    • HNSCC
    • Pancreatic adenocarcinoma
    • Breast 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) 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
    • Key Exclusion Criteria
    • 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.
    • A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation

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    A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation

    How to Participate

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    Locations

    Recruiting

    United States, California

    City of Hope

    Duarte, California, United States, 91010

    Recruiting

    United States, California

    University of California, Los Angeles (UCLA)

    The Angels, California, United States, 90095

    Recruiting

    United States, California

    Hoag Medical Group

    Newport Beach, California, United States, 92663

    Recruiting

    United States, Massachusetts

    Dana-Farber Cancer Institute

    Boston, Massachusetts, United States, 02215

    Recruiting

    United States, New Jersey

    Rutgers University

    New Brunswick, New Jersey, United States, 09803

    Recruiting

    United States, Texas

    Baylor Scott & White Medical Center

    dallas, Texas, United States, 75246