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RECRUITING
NCT05877599
PHASE1

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

Official title: An Open-label, Phase 1, Multicenter Study to Evaluate the Safety and Preliminary Anti-tumor Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Subjects With Unresectable, Advanced and/or Metastatic Solid Tumors That Are Positive for the TP53 R175H Mutation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2023-07-12

Completion Date

2029-07-31

Last Updated

2026-03-05

Healthy Volunteers

No

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)

Locations (18)

Research Site

Gilbert, Arizona, United States

Research Site

Duarte, California, United States

Research Site

Newport Beach, California, United States

Research Site

Santa Monica, California, United States

Research Site

Jacksonville, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Tampa, Florida, United States

Research Site

Boston, Massachusetts, United States

Research Site

New Brunswick, New Jersey, United States

Research Site

New York, New York, United States

Research Site

Charlotte, North Carolina, United States

Research Site

Winston-Salem, North Carolina, United States

Research Site

Portland, Oregon, United States

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Nashville, Tennessee, United States

Research Site

Houston, Texas, United States

Research Site

Round Rock, Texas, United States

Research Site

Milwaukee, Wisconsin, United States