MT2019-47 Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, alone or in combination with other agents, in HLA-A2+ Participants with NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO) Protocol Number: 208467
This is a master protocol to investigate the safety and antitumor activity of T-cell receptor (TCR) engineered NY-ESO-1 Specific (c259) T Cells alone or in combination with other agents in HLA-A*02+ participants with NY-ESO-1 and/or LAGE-1a positive solid tumors. The protocol will initially include a substudy to investigate letestregene autoleucel (lete-cel, GSK3377794) treatment in previously untreated (1L) HLA-A*02+ participants with NYESO-1+ advanced (metastatic or unresectable synovial sarcoma or myxoid/round cell liposarcoma (Substudy 1). A separate substudy will investigate letestregene autoleucel (lete-cel, GSK3377794) infusion as second line or higher (2L+) treatment in HLA-A*02+ participants with NY-ESO-1+ advanced metastatic or unresectable synovial sarcoma or myxoid/round cell liposarcoma, who have progressed following treatment with anthracycline based chemotherapy for the purpose of registration (Substudy 2). The protocol may be amended at a later time to add additional substudies to investigate other NY-ESO-1 or LAGE-1a positive tumor types and other NY-ESO-1-Specific (c259) T Cells (potentially in combination with other agents).
Adoptive T-cell therapy, Advanced metastatic disease, Advanced unresectable disease, Clinics and Surgery Center (CSC), GSK3377794, Lete-cel, Letetresgene autoleucel, Leukapheresis, Myxoid/round cell liposarcoma, Positive solid tumors, Synovial sarcoma, T-cell receptors