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OncoMatch/Clinical Trials/NCT05877599

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

Is NCT05877599 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Autologous, engineered T Cells targeting TP53 R175H for non-small cell lung cancer.

Phase 1RecruitingAstraZenecaNCT05877599Data as of May 2026

Treatment: Autologous, engineered T Cells targeting TP53 R175HPhase 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Head and Neck Squamous Cell Carcinoma

Colorectal Cancer

Pancreatic Cancer

Breast Carcinoma

Tumor Agnostic

Ovarian Cancer

Biomarker criteria

Required: TP53 R175H mutation

Tumors must harbor a TP53 R175H variant mutation

Required: HLA-A A*02:01 positive (at least 1 allele)

subject must be HLA-A*02:01 positive (at least 1 allele)

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: systemic standard of care

after at least 1 line of approved systemic standard of care (SOC) treatment regimen

Cannot have received: adoptive cell and gene therapy

History of prior adoptive cell and gene therapy

Cannot have received: allogeneic stem cell transplant

allogeneic stem cell transplant

Cannot have received: solid organ transplantation

solid organ transplantation

Cannot have received: systemic therapy

Exception: within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment

Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment

Lab requirements

Blood counts

Kidney function

Liver function

Cardiac function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Research Site · Gilbert, Arizona
  • Research Site · Duarte, California
  • Research Site · Newport Beach, California
  • Research Site · Santa Monica, California
  • Research Site · Jacksonville, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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