RecruitingPhase 1NCT05877599

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

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


Sponsor

AstraZeneca

Enrollment

45 participants

Start Date

Jul 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests NT-175, a new type of immune cell therapy called a T-cell receptor therapy, in people with advanced solid tumors that carry two specific biological markers: a TP53 R175H gene mutation and a specific immune-related marker called HLA-A*02:01. The therapy uses the patient's own immune cells, engineered to recognize and attack cancer cells with this mutation. **You may be eligible if...** - You are 18 or older with advanced (stage III or IV) solid cancer including lung, colorectal, head/neck, pancreatic, breast, ovarian, or other cancers - Your tumor has been tested and has both the TP53 R175H mutation AND the HLA-A*02:01 marker - You have received at least one prior standard treatment with no available curative options - Your general health is good (ECOG 0–1) **You may NOT be eligible if...** - You have had a prior cell or gene therapy, stem cell transplant, or organ transplant - You had a stroke or heart attack within the past year - You have significant heart disease - You have Li-Fraumeni syndrome or a family history of it - You are pregnant or breastfeeding - You have an active immune disease requiring steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous, 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

View Full Details on ClinicalTrials.gov

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NCT05877599


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