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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
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
Conditions
Interventions
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
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Duarte, California, United States
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Newport Beach, California, United States
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Santa Monica, California, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Tampa, Florida, United States
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Boston, Massachusetts, United States
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New Brunswick, New Jersey, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Round Rock, Texas, United States
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Milwaukee, Wisconsin, United States