Phase 1 Study of NT-175, a T Cell Therapy, in Adults With Advanced Cancers Positive for HLA-A*0201 and TP53 R175H Mutation

What this Trial Is About

Researchers are evaluating NT-175, an autologous T cell therapy engineered to express a specific T cell receptor targeting TP53 R175H mutant cancers. This Phase 1, open-label, multicenter study focuses on adults with advanced malignancies positive for HLA-A*0201 and the TP53 R175H mutation. The study aims to assess the safety and preliminary anti-tumor activity of NT-175 in these patients with advanced solid tumors or hematological malignancies. Participants will receive NT-175 after pre-conditioning with non-myeloablative chemotherapy using fludarabine and cyclophosphamide. The treatment involves a single infusion of the engineered T cells followed by post-infusion recombinant interleukin-2 rIL-2. The study includes a dose escalation phase to find the maximum tolerated dose or recommended phase 2 dose, a cohort expansion phase to further evaluate safety and activity, and a dose expansion phase to study preliminary anti-tumor effects and safety at the recommended dose. Throughout the study, participants will undergo safety monitoring up to 24 months after infusion. Researchers will evaluate adverse effects and anti-tumor activity in both solid and hematological cancers. Assessments include measuring lesions, performance status, and organ function, with follow-up visits scheduled to monitor treatment impact and safety outcomes. The total study duration extends up to two years post-infusion, ensuring comprehensive observation of participant responses and safety.

A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation