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OncoMatch/Clinical Trials/NCT05877599

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

Is NCT05877599 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies NT-175 for non-small cell lung cancer.

Phase 1RecruitingAstraZenecaNCT05877599Data as of Sep 2026

Treatment: NT-175Phase 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

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Extracted eligibility criteria

Treatments studied

Other

NT-175

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

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 therapy — advanced solid cancer

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

History of prior allogeneic stem cell transplant

Cannot have received: solid organ transplantation

History of prior solid organ transplantation

Cannot have received: adoptive modified cell therapy

Prior adoptive modified cell therapy

Lab requirements

Blood counts

Kidney function

Liver function

Cardiac function

Adequate hematological, renal, hepatic, pulmonary, and 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 →

Frequently asked questions

Is NCT05877599 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior adoptive cell and gene therapy, allogeneic stem cell transplant, solid organ transplantation disqualifies patients from enrollment.

Does this trial require TP53?

Yes, TP53 r175h is a required biomarker for enrollment.

Does this trial require HLA-A?

Yes, HLA-A a*02:01 positive (at least 1 allele) is a required biomarker for enrollment.

What disease stage is eligible?

Stage III or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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