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 (Jun 2026). This Phase 1 trial studies Autologous, engineered T Cells targeting TP53 R175H for non-small cell lung cancer.
Treatment: Autologous, engineered T Cells targeting TP53 R175H — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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
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 →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 mutation 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.
Check if I qualify