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
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 29, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- AstraZeneca
- Interventions being studied
- Biological: NT-175
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key (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
- (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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Research SiteGilbert, Arizona
- Research SiteDuarte, California
- Research SiteLos Angeles, California
- Research SiteNewport Beach, California
- Research SiteSanta Monica, California
- Research SiteJacksonville, Florida
- Research SiteMiami, Florida
- Research SiteTampa, Florida
- Research SiteBoston, Massachusetts
- Research SiteBoston, Massachusetts
- Research SiteNew Brunswick, New Jersey
- Research SiteNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 29, 2026. Always confirm current availability with the study team.