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Trial record 1 of 1 for:    NCT05877599
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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

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ClinicalTrials.gov Identifier: NCT05877599
Recruitment Status : Recruiting
First Posted : May 26, 2023
Last Update Posted : October 23, 2023
Sponsor:
Information provided by (Responsible Party):
Neogene Therapeutics, Inc.

Study Description
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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 Intervention/treatment Phase
Non-small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma Colorectal Carcinoma Pancreatic Adenocarcinoma Breast Cancer Other Solid Tumors Biological: Autologous, engineered T Cells targeting TP53 R175H 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Sequential Assignment
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation
Dose Escalation of TCR T cell product
 Biological: Autologous, engineered T Cells targeting TP53 R175H
  • Pre-conditioning by non-myeloablative chemotherapy with fludarabine and cyclophosphamide
  • Single infusion TCR T cells
  • Post-infusion recombinant interleukin-2 (rIL-2)


Outcome Measures
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Primary Outcome Measures :
  1. Safety of NT-175 in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: 28 days after infusion ]
    Incidence of dose-limiting toxicities (DLTs) after the infusion of NT-175

  2. Adverse events and serious adverse events [ Time Frame: Up to 24 months post-infusion ]
    Incidence of adverse events and serious adverse events by dose level


Secondary Outcome Measures :
  1. Preliminary anti-tumor activity of NT-175 in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: Up to 24 months after infusion ]
    Objective Response Rate (ORR) per RECIST V1.1 determined by Investigator assessment.

  2. Preliminary anti-tumor activity of NT-175 in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: Up to 24 months after infusion ]
    Best Overall Response (BOR) per RECIST V1.1 determined by Investigator assessment.

  3. Preliminary anti-tumor activity of NT-175 in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: Up to 24 months after infusion ]
    Duration of Response (DOR) per RECIST V1.1 determined by Investigator assessment.

  4. Preliminary anti-tumor activity of NT-175 in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: Up to 24 months after infusion ]
    Clinical Benefit Rate (CBR) per RECIST V1.1 determined by Investigator assessment.

  5. Preliminary anti-tumor activity of NT-175 in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: Up to 24 months after infusion ]
    Time to Response (TTR) per RECIST V1.1 determined by Investigator assessment.

  6. Preliminary anti-tumor activity of NT-175 in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: Up to 24 months after infusion ]
    Progression-free survival (PFS) per RECIST V1.1 determined by Investigator assessment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (confirmed by an FDA-approved test), 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 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

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05877599


Contacts
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Contact: Neogene Medical Affairs (310) 742-9929 MedicalAffairs@neogene.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Marwan Fakih, Dr.    626-256-4673    mfakih@coh.org   
University of California, Los Angeles (UCLA) Recruiting
Los Angeles, California, United States, 90095
Contact: Chris Hannigan    310-825-4493    CHannigan@mednet.ucla.edu   
Hoag Medical Group Recruiting
Newport Beach, California, United States, 92663
Contact: Chi Nguyen    949-764-5543    Chi.Nguyen@hoag.org   
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Mark Awad, MD       Mark_Awad@dfci.harvard.edu   
Contact: Hope Wei       HopeY_Wei@DFCI.HARVARD.EDU   
United States, Texas
Baylor Scott & White Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Study Director       corcsolidtumor@BSWHealth.org   
Sponsors and Collaborators
Neogene Therapeutics, Inc.
Investigators
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Study Director: Medical Affairs Neogene Therapeutics
More Information
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Responsible Party: Neogene Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05877599    
Other Study ID Numbers: NT-175-201
First Posted: May 26, 2023    Key Record Dates
Last Update Posted: October 23, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Squamous Cell Carcinoma of Head and Neck
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Carcinoma, Squamous Cell
Head and Neck Neoplasms
 Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases