A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation
Condition(s) studied
Investigational drug(s) / intervention(s)
NT-175: * Pre-conditioning by non-myeloablative chemotherapy with fludarabine and cyclophosphamide * Single infusion Autologous, engineered T Cells targeting TP53 R175H * Post-infusion recombinant interleukin-2 (rIL-2)
Study 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 malignancies
Eligibility
Primary outcome measure(s)
- Module 1, Part 1: Safety of NT-175 in participants with unresectable, advanced, and/or metastatic solid tumours — 28 days after infusion
Incidence of dose-limiting toxicities (DLTs) after the infusion of NT-175 - Module 1, Part 1: Safety of NT-175 in participants with unresectable, advanced, and/or metastatic solid tumours — Up to 24 months post-infusion
Incidence of Treatment Emergent Adverse Events (TEAE) Serious Adverse Events (SAE) - Module 1, Part 2: Preliminary anti-tumour activity of NT-175 in participants with unresectable, advanced, and/or metastatic solid tumours — Up to 24 months after infusion
Per RECIST v1.1 determined by Investigator assessment: * Objective Response Rate (ORR) * Best Overall Response (BOR) * Duration of Response (DOR) * Clinical Benefit Rate (CBR) * Time to Response (TTR) * Progression-free survival (PFS) * Overall Survival (OS) - Module 2: Safety of NT-175 in participants with haematological malignancies — Up to 28 days after infusion
\- Incidence of dose-limiting toxicities (DLTs) after the infusion of NT-175 - Module 2: Safety of NT-175 in participants with haematological malignancies — Up to 24 months after infusion
* Incidence of Treatment Emergent Adverse Events (TEAE) * Serious Adverse Events (SAE)
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Gilbert | Arizona | Recruiting |
| Research Site | Duarte | California | Recruiting |
| Research Site | Los Angeles | California | Recruiting |
| Research Site | Newport Beach | California | Recruiting |
| Research Site | Santa Monica | California | Recruiting |
| Research Site | Jacksonville | Florida | Recruiting |
| Research Site | Miami | Florida | Withdrawn |
| Research Site | Tampa | Florida | Withdrawn |
| Research Site | Boston | Massachusetts | Recruiting |
| Research Site | Boston | Massachusetts | Recruiting |
| Research Site | New Brunswick | New Jersey | Recruiting |
| Research Site | New York | New York | Recruiting |
| Research Site | Charlotte | North Carolina | Withdrawn |
| Research Site | Winston-Salem | North Carolina | Withdrawn |
| Research Site | Portland | Oregon | Recruiting |
| Research Site | Pittsburgh | Pennsylvania | Recruiting |
| Research Site | Nashville | Tennessee | Recruiting |
| Research Site | Houston | Texas | Recruiting |
| Research Site | Round Rock | Texas | Recruiting |
| Research Site | Milwaukee | Wisconsin | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05877599 on ClinicalTrials.gov ↗ ← All trials in the USA