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
NCT05877599 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2026-05-13
Summary
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.
Conditions
- Non-small Cell Lung Cancer
- Head and Neck Squamous Cell Carcinoma
- Colorectal Carcinoma
- Pancreatic Adenocarcinoma
- Breast Cancer
- Other Solid Tumors
- Ovarian Cancer
Interventions
- BIOLOGICAL
-
Autologous, engineered T Cells targeting TP53 R175H
* Pre-conditioning by non-myeloablative chemotherapy with fludarabine and cyclophosphamide * Single infusion TCR T cells * Post-infusion recombinant interleukin-2 (rIL-2)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
AstraZeneca · AstraZeneca
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-12
- Primary Completion
- 2029-07-31
- Completion
- 2029-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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