Table 1.

Clinical trials targeting NY-ESO-1

Study namePhaseStatusTarget accrualEstimated primary completion date
Adoptive T-cell therapy
NCT01477021A phase I study to determine the feasibility of using autologous NY-ESO-1–specific CD8+ T cells for the treatment of patients with advanced myxoid/round cell liposarcoma and synovial sarcomaICompleted6September 2013
NCT01343043A pilot study of genetically engineered NY-ESO-1–specific NY-ESO-1c259 T cells in HLA-A2+ patients with synovial sarcomaI/IIRecruiting65October 2018
NCT02869217Phase Ib study of TBI-1301 (NY-ESO-1–specific TCR-gene–transduced autologous T lymphocytes) in patients with solid tumorsIRecruiting15March 2018
NCT02457650Phase I study of malignancies that express NY-ESO-1 with TCR-transduced T cells targeting NY-ESO-1IRecruiting36December 2019
NCT03250325Study of TBI-1301 (NY-ESO-1 TCR-gene-transduced autologous T lymphocytes) in patients with synovial sarcomaI/IIRecruiting8January 2020
NCT01967823Phase II study of metastatic cancer that expresses NY-ESO-1 using lymphodepleting conditioning followed by infusion of anti–NY-ESO-1 murine TCR-gene–engineered lymphocytesIIRecruiting43July 2027
NCT03399448Phase I trial of autologous T cells engineered to express NY-ESO-1 TCR and CRISPR gene edited to eliminate endogenous TCR and PD-1 (NYCE T cells)IRecruiting18January 2033
Vaccine therapy
NCT01241162A phase I trial combining decitabine and vaccine therapy for patients with relapsed neuroblastoma and sarcomaICompleted19October 2016
NCT02609984A randomized, open-label, phase II trial of CMB305 (sequentially administered LV305 and G305) and atezolizumab in patients with locally advanced, relapsed, or metastatic sarcoma expressing NY-ESO-1IIActive, not recruiting88May 2017
NCT02122861A phase I, open-label clinical trial evaluating the safety, tolerability, and immunogenicity of intradermally administered ID-LV305 in patients with locally advanced, relapsed, or metastatic cancer expressing NY-ESO-1IActive, not recruiting47December 2017
NCT03520959A phase III, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of CMB305 in unresectable locally advanced or metastatic NY-ESO-1+ synovial sarcoma following first-line systemic anticancer therapy (Synovate study)IIINot yet open248
Combination ACT and/or vaccine therapy in combination with other therapy
NCT02070406NY-ESO-1 TCR–engineered adoptive cell transfer therapy with CTLA4 blockadeIRecruiting12July 2019
NCT03450122A phase I study of cellular adoptive immunotherapy using autologous CD8+ NY-ESO-1–specific T cells and the NY-ESO-1 immunostimulatory agents LV305 or CMB305 for patients with sarcomaINot yet open18
NCT03515551A phase I/II study of IMCnyeso, HLA-A*0201-restricted, NY-ESO-1– and LAGE-1A–specific soluble TCR and anti-CD3 bispecific molecule, in HLA-A*0201–positive patients with advanced NY-ESO-1 and/or LAGE-1A–positive cancerI/IINot yet open63