INTERNATIONAL: Study Of TBI-1301 (NY-ESO-1 Specific TCR GeneTransduced Autologous T Lymphocytes) In Patients With Solid Tumors
Trial ID: NCT02869217
Phase: Phase 1
Status: Active but not recruiting
Last Update Posted: December 2025
Please Note: This trial is no longer enrolling new patients but remains active for follow-up of enrolled participants.
Eligibility: Patients aged 16 and older with metastatic or recurrent unresectable solid tumors, including synovial sarcoma, who are HLA-A*02:01 or HLA-A*02:06 positive and whose tumors express the NY-ESO-1 antigen confirmed by immunohistochemistry. Patients must have measurable disease and an ECOG performance status of 0-1.
Overview: This Phase 1 trial evaluates TBI-1301, a TCR gene 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 an intravenous infusion of the modified T-cells. The study evaluates two approaches: a retreatment cohort for patients who have previously received TBI-1301, and a double infusion cohort in which T-cells are given on Day 0 and again on Day 14.
Preliminary Effectiveness: No formal results have been posted to ClinicalTrials.gov at this time. The study aims to establish a recommended Phase 2 dose and evaluate early signs of anti-tumor activity using RECIST v1.1.
Treatment Centers: Canada