^
    5d
    ZENYTH-ESO: Master Protocol to Assess Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=12, Terminated, GlaxoSmithKline | Trial completion date: Dec 2025 --> Jun 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Jun 2023; The study was terminated due to a change in GSK's R&D priorities.
    Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • CTAG2 (Cancer/testis antigen 2)
    |
    HLA-A*02:01 • HLA-A*02 • HLA-A2 positive • CTAG2 expression
    |
    cyclophosphamide • fludarabine IV • GSK3845097 • GSK3901961 • LYL132
    8ms
    Study of GSK3901961 In Previously Treated Advanced (Metastatic OR Unresectable) Synovial Sarcoma/ Myxoid/Round Cell Liposarcoma, and Previously Treated Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=7, Terminated, GlaxoSmithKline
    New P1 trial • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • CTAG2 (Cancer/testis antigen 2)
    |
    HLA-A*02:01 • HLA-A*02 • HLA-A2 positive • CTAG2 expression
    |
    cyclophosphamide • fludarabine IV • GSK3901961
    over1year
    ZENYTH-ESO: Master Protocol to Assess Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=11, Active, not recruiting, GlaxoSmithKline | Recruiting --> Active, not recruiting | N=67 --> 11 | Trial completion date: Feb 2024 --> Dec 2025 | Trial primary completion date: Feb 2024 --> Dec 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • CTAG2 (Cancer/testis antigen 2)
    |
    HLA-A*02:01 • HLA-A*02 • HLA-A2 positive • CTAG2 expression
    |
    cyclophosphamide • fludarabine IV • GSK3845097 • GSK3901961 • LYL132
    over1year
    ZENYTH-ESO: Master protocol to assess the safety and recommended phase II dose of next generation NY-ESO-1-specific TCR T-cells in HLA-A*02 patients with synovial sarcoma, myxoid/round cell liposarcoma and non- small cell lung cancer [Substudy 1 (GSK3901961) and Substudy 2 (GSK3845097)] (DKK 2022)
    Background: Letetresgene autoleucel (lete-cel; GSK3377794) is an autologous T-cell therapy expressing an affinity-enhanced T-cell recep- tor (TCR) to improve recognition of cancer cells expressing NY-ESO-1 and/or LAGE-1a. This master protocol will evaluate the safety and efficacy of next generation NY-ESO-1 specific TCR-T cells in SS/MRCLS or NSCLC.
    Clinical • P2 data
    |
    CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • TGFB1 (Transforming Growth Factor Beta 1) • CTAG2 (Cancer/testis antigen 2)
    |
    HLA-A*02 • CTAG1B expression
    |
    letetresgene autoleucel (GSK3377794) • GSK3845097 • GSK3901961
    over1year
    ZENYTH-ESO Substudy 1 (GSK3901961), Cohort 1: a first-in-human study to assess the safety and recommended phase II dose of next generation NY-ESO-1-specific TCR T-cells in HLA-A*02 patients with non-small cell lung cancer (DKK 2022)
    Background: Letetresgene autoleucel (lete-cel; GSK3377794) is an autologous T cell therapy expressing an affinity-enhanced T cell receptors (TCR) to improve recognition of cancer cells expressing NY-ESO-1 and/or LAGE-1a. This study is recruiting. This substudy will evaluate the safety and efficacy of GSK3901961 in NSCLC.
    Clinical • P1 data • P2 data • IO biomarker
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • CD4 (CD4 Molecule) • CTAG2 (Cancer/testis antigen 2)
    |
    CD8 expression • HLA-A*02 • CTAG1B expression • CTAG2 expression
    |
    letetresgene autoleucel (GSK3377794) • GSK3901961
    over1year
    ZENYTH-ESO: Master Protocol to Assess Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=67, Recruiting, GlaxoSmithKline | N=50 --> 67
    Enrollment change • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • CTAG2 (Cancer/testis antigen 2)
    |
    HLA-A*02:01 • HLA-A*02 • HLA-A2 positive • CTAG2 expression
    |
    cyclophosphamide • fludarabine IV • GSK3845097 • GSK3901961 • LYL132
    2years
    ZENYTH-ESO: Master Protocol to Assess Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=50, Recruiting, GlaxoSmithKline | N=38 --> 50
    Enrollment change • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • CTAG2 (Cancer/testis antigen 2)
    |
    HLA-A*02:01 • HLA-A*02 • HLA-A2 positive • CTAG2 expression
    |
    cyclophosphamide • fludarabine IV • GSK3845097 • GSK3901961 • LYL132
    over2years
    SAFETY AND RECOMMENDED PHASE 2 DOSE OF NEXT GENERATION NY-ESO-1-SPECIFIC TCR T-CELLS IN HLA-A*02 PATIENTS WITH SYNOVIAL SARCOMA OR NON-SMALL CELL LUNG CANCER: MASTER PROTOCOL (SUBSTUDIES 1 AND 2) (CTOS 2021)
    Objective: Letetresgene autoleucel (lete-cel; GSK3377794) is an autologous T-cell therapy using a genetically modified T-cell receptor (TCR) to improve recognition of cancer cells expressing NY-ESO-1/LAGE-1a...Exploratory endpoints include laboratory parameters, overall survival, and anti-GSK3901961 or -GSK3845097 titers as applicable... This study was funded by GSK (209012; NCT04526509). Editorial support was provided by Eithne Maguire, PhD and Katie Crossland, PhD of Fishawack Indicia, part of Fishawack Health, UK; funded by GSK. This abstract was previously presented at the American Association for Cancer Research (April 10–15 and May 17–21, 2021) and the American Society of Clinical Oncology Annual Meeting (June 4–8, 2021).
    Clinical • P2 data • IO biomarker
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • CD4 (CD4 Molecule) • TGFB1 (Transforming Growth Factor Beta 1) • CTAG2 (Cancer/testis antigen 2)
    |
    CD8 expression • CTAG1B expression
    |
    letetresgene autoleucel (GSK3377794) • GSK3845097 • GSK3901961
    3years
    [VIRTUAL] Master protocol to assess safety and recommended phase 2 dose of next generation NY-ESO-1–specific TCR T-cells in HLA-A*02 patients with synovial sarcoma or non-small cell lung cancer (Substudies 1 and 2). (ASCO 2021)
    Clinical Trial Registry Number: NCT04526509 Funding: GlaxoSmithKline (209012) Background: Letetresgene autoleucel (lete-cel; GSK3377794) is an autologous T-cell therapy using a genetically modified T-cell receptor (TCR) to improve recognition of cancer cells expressing NY-ESO-1/LAGE-1a . Exploratory endpoints include laboratory parameters, overall survival, and anti-GSK3901961 or -GSK3845097 titers as applicable . Analyses will be descriptive.
    P2 data • Clinical • IO biomarker
    |
    CTAG1B (Cancer/testis antigen 1B) • CD4 (CD4 Molecule) • TGFB1 (Transforming Growth Factor Beta 1) • CTAG2 (Cancer/testis antigen 2)
    |
    CD8 expression • CTAG1B expression
    |
    letetresgene autoleucel (GSK3377794) • GSK3845097 • GSK3901961
    3years
    [VIRTUAL] Master protocol to assess the safety and recommended Phase 2 dose of next generation NY-ESO-1-specific TCR T-cells in HLA-A*02 patients with synovial sarcoma and non-small cell lung cancer (AACR 2021)
    Funding: GSK (209012; NCT04526509) Background: Letetresgene autoleucel (lete-cel; GSK3377794) is an autologous T-cell therapy expressing a genetically modified T-cell receptor (TCR) to improve recognition of cancer cells expressing NY-ESO-1 and/or LAGE-1a. Exploratory endpoints include laboratory parameters, overall survival, and anti-GSK3901961 and anti-GSK3845097 titers for the respective substudies. The substudies are open and recruiting.
    Clinical • P2 data
    |
    CTAG1B (Cancer/testis antigen 1B) • CD4 (CD4 Molecule) • TGFB1 (Transforming Growth Factor Beta 1) • CTAG2 (Cancer/testis antigen 2)
    |
    CD8 expression • CTAG1B expression
    |
    letetresgene autoleucel (GSK3377794) • GSK3845097 • GSK3901961
    over3years
    [VIRTUAL] CD8Α-ENHANCED NY-ESO-1-SPECIFIC TCR T CELLS (GSK3901961) IN HLA-A*02 PATIENTS WITH NSCLC: MASTER PROTOCOL SUBSTUDY 1 (EBMT 2021)
    Background: Letetresgene autoleucel (lete-cel; GSK3377794) is an autologous T cell therapy engineered to express a modified T cell receptor (TCR) to improve recognition of NY-ESO-1 and/or LAGE-1a expressing cancer cells. Exploratory endpoints include laboratory parameters, overall survival, progression-free survival, disease control rate, time to response, and anti-GSK3901961 titers. The study is currently open and recruiting.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CTAG1B (Cancer/testis antigen 1B) • CD4 (CD4 Molecule) • CTAG2 (Cancer/testis antigen 2)
    |
    CD8 expression • CTAG1B expression • CTAG2 expression
    |
    letetresgene autoleucel (GSK3377794) • GSK3901961
    over3years
    [VIRTUAL] CD8Α-ENHANCED NY-ESO-1-SPECIFIC TCR T CELLS (GSK3901961) IN HLA-A*02 PATIENTS WITH NSCLC: MASTER PROTOCOL SUBSTUDY 1 (EBMT 2021)
    Background: Letetresgene autoleucel (lete-cel; GSK3377794) is an autologous T cell therapy engineered to express a modified T cell receptor (TCR) to improve recognition of NY-ESO-1 and/or LAGE-1a expressing cancer cells. Exploratory endpoints include laboratory parameters, overall survival, progression-free survival, disease control rate, time to response, and anti-GSK3901961 titers. The study is currently open and recruiting.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CTAG1B (Cancer/testis antigen 1B) • CD4 (CD4 Molecule) • CTAG2 (Cancer/testis antigen 2)
    |
    CD8 expression • CTAG1B expression • CTAG2 expression
    |
    letetresgene autoleucel (GSK3377794) • GSK3901961
    over3years
    [VIRTUAL] CD8Α-ENHANCED NY-ESO-1-SPECIFIC TCR T CELLS (GSK3901961) IN HLA-A*02 PATIENTS WITH NSCLC: MASTER PROTOCOL SUBSTUDY 1 (EBMT 2021)
    Background: Letetresgene autoleucel (lete-cel; GSK3377794) is an autologous T cell therapy engineered to express a modified T cell receptor (TCR) to improve recognition of NY-ESO-1 and/or LAGE-1a expressing cancer cells. Exploratory endpoints include laboratory parameters, overall survival, progression-free survival, disease control rate, time to response, and anti-GSK3901961 titers. The study is currently open and recruiting.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CTAG1B (Cancer/testis antigen 1B) • CD4 (CD4 Molecule) • CTAG2 (Cancer/testis antigen 2)
    |
    CD8 expression • CTAG1B expression • CTAG2 expression
    |
    letetresgene autoleucel (GSK3377794) • GSK3901961
    over3years
    [VIRTUAL] CD8Α-ENHANCED NY-ESO-1-SPECIFIC TCR T CELLS (GSK3901961) IN HLA-A*02 PATIENTS WITH NSCLC: MASTER PROTOCOL SUBSTUDY 1 (EBMT 2021)
    Background: Letetresgene autoleucel (lete-cel; GSK3377794) is an autologous T cell therapy engineered to express a modified T cell receptor (TCR) to improve recognition of NY-ESO-1 and/or LAGE-1a expressing cancer cells. Exploratory endpoints include laboratory parameters, overall survival, progression-free survival, disease control rate, time to response, and anti-GSK3901961 titers. The study is currently open and recruiting.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CTAG1B (Cancer/testis antigen 1B) • CD4 (CD4 Molecule) • CTAG2 (Cancer/testis antigen 2)
    |
    CD8 expression • CTAG1B expression • CTAG2 expression
    |
    letetresgene autoleucel (GSK3377794) • GSK3901961
    over3years
    Master Protocol to Assess the Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=38, Recruiting, GlaxoSmithKline | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    CTAG1B expression
    |
    fludarabine IV • GSK3845097 • GSK3901961 • cyclophosphamide intravenous