RecruitingPhase 1NCT05877599

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

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

Checked against the public recordLast updated Aug 6, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 1
U.S. locations18
SponsorAstraZeneca
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
AstraZeneca
Interventions being studied
Biological: NT-175
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteGilbert, Arizona
  • Research SiteDuarte, California
  • Research SiteNewport Beach, California
  • Research SiteSanta Monica, California
  • Research SiteJacksonville, Florida
  • Research SiteMiami, Florida
  • Research SiteTampa, Florida
  • Research SiteBoston, Massachusetts
  • Research SiteNew Brunswick, New Jersey
  • Research SiteNew York, New York
  • Research SiteCharlotte, North Carolina
  • Research SiteWinston-Salem, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 6, 2026. Always confirm current availability with the study team.

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