INTERNATIONAL: Investigator Initiated Phase 1 Study of TBI-1301 (NY-ESO-1 Specific TCRGene Transferred T Lymphocytes)
Trial ID: NCT02366546
Phase: Phase 1
Status: Other, Unknown
Last Update Posted: October 2018
Please Note: This trial’s status has not been updated since October 2018. The primary completion date was September 2018 and enrollment has closed with 9 patients enrolled. Patients should contact the study team directly to confirm current status before pursuing enrollment.
Eligibility: Adults aged 20 and older with unresectable solid tumors, including synovial sarcoma, that are refractory to standard therapy, are HLA-A*02:01 or HLA-A*02:06 positive, and whose tumors express the NY-ESO-1 antigen confirmed by PCR or immunohistochemistry. Patients must have 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 target NY-ESO-1-expressing cancer cells. Patients first receive lymphodepleting chemotherapy with cyclophosphamide alone or in combination with fludarabine, followed by a single infusion of the engineered T-cells. The primary objectives were to evaluate safety, tolerability, and the persistence of transferred T-cells in the blood.
Preliminary Effectiveness: No formal results have been posted to ClinicalTrials.gov. A 2022 publication in the Journal for ImmunoTherapy of Cancer reported that NY-ESO-1 TCR-redirected T-cells showed tumor responses alongside cytokine release syndrome in treated patients, providing early evidence of both activity and immune-related side effects with this approach.
Study Contact: Mie University Hospital, Tsu, Japan
Treatment Centers: Japan