Phase III Study of Anti-NY-ESO-1 T Cell Receptor Gene-Engineered Lymphocyte Infusions for Patients With NY-ESO-1 Positive Metastatic Cancers

What this Trial Is About

Researchers are evaluating a Phase III study to assess the safety, dosing, and effectiveness of anti-NY-ESO-1 T cell receptor TCR-gene engineered lymphocytes called HBI 0201-ESO TCRT. This treatment targets patients with metastatic cancers that express the NY-ESO-1 protein, including various sarcomas, melanoma, breast, lung, bladder, neuroblastoma, and ovarian cancers. The study aims to find the best tolerated dose and evaluate clinical response rates in this population. The trial has two parts. Part A involves dose escalation with up to 20 patients receiving increasing doses of HBI 0201-ESO TCRT after preparative chemotherapy with cyclophosphamide and fludarabine. Part B is an expansion phase with up to 43 patients treated at the selected safe dose. The HBI 0201-ESO TCRT cells are infused on Day 0, followed by a continuous infusion of aldesleukin for four days or until specific side effects occur. The dose levels of engineered lymphocytes being tested range from 1x109 to 1x1010 cells. Participants will be monitored for treatment-related side effects and tumor response over five years. Assessments include immune monitoring for the persistence of infused cells and evaluation of tumor shrinkage. Safety and tolerability will be closely observed, including adverse events related to the treatment. The study requires patients to have measurable metastatic cancer expressing NY-ESO-1 and to meet specific health and laboratory criteria before enrollment.

Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers