INTERNATIONAL: Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes for NY-ESO-1 ExpressingMetastatic Cancers
Trial ID: NCT05296564
Phase: Phase 1/2
Status: Recruiting
Last Update Posted: October 2025
Eligibility: Adults aged 18 to 70 with metastatic or locally advanced refractory cancer, including synovial sarcoma, whose tumors express the NY-ESO-1 antigen and who are HLA-A*02:01 or A*02:06 positive. Patients must have measurable disease, have received at least one prior line of standard therapy, and have an ECOG performance status of 0-2.
Overview: This Phase 1/2 trial evaluates HBI 0201-ESO TCRT, a TCR-engineered T-cell therapy in which a patient’s own T-cells are genetically modified to recognize and attack NY-ESO-1-expressing cancer cells. Patients first receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by a single infusion of the engineered T-cells and low-dose interleukin-2 to support T-cell persistence. Part A establishes the maximum tolerated dose across three dose levels, and Part B expands enrollment at the safe dose to evaluate clinical response rates.
Preliminary Effectiveness: As an early-stage Phase 1/2 trial, no results have been posted to ClinicalTrials.gov at this time. The study aims to evaluate safety, objective tumor regression, and persistence of the transferred T-cells in the blood over five years.
Study Contact: Hadassah Medical Organization
- Michal Lotem, Prof.: mlotem@hadassah.org.il / +972 508 573 528
- Yafit Halutsi: yafitha@hadassah.com / +972 526 906 339
Treatment Centers: Israel