- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), letetresgene autoleucel (GSK3377794) / Adaptimmune
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases: Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab (clinicaltrials.gov) - Dec 5, 2022 P1b/2a, N=34, Terminated, Lete-cel had a manageable safety profile consistent with other lete-cel studies and demonstrated clear but transient antitumor activity in patients with RRMM. N=54 --> 34 | Trial completion date: May 2025 --> Nov 2022 | Active, not recruiting --> Terminated | Trial primary completion date: May 2025 --> Jun 2022; The study was terminated for reasons pertaining to feasibility
- |||||||||| letetresgene autoleucel (GSK3377794) / Adaptimmune
Biomarker correlates of letetresgene autoleucel (lete-cel; GSK3377794) response in patients with advanced myxoid/round cell liposarcoma (MRCLS) (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_928; P2 Preliminary gene expression data from the tumors collected at baseline showed enrichment of metabolic pathways in responders and epithelial–mesenchymal transition and fibroblast activation in non-responders. Conclusions These data suggest that higher lete-cel persistence and the association of lete-cel expansion with cytokine upregulation post-infusion, as well as tumor-intrinsic transcriptional features, may have a role in lete-cel response in patients with advanced MRCLS.
- |||||||||| NY-ESO-1 TCR / Gilead
Biomarker, Journal, IO biomarker: Biomarker correlates with response to NY-ESO-1 TCR T cells in patients with synovial sarcoma. (Pubmed Central) - Sep 18, 2022 P1 Analysis of tumor samples post-treatment illustrates lete-cel infiltration and a decrease in expression of macrophage genes, suggesting remodeling of the tumor microenvironment. Here we report potential predictive and pharmacodynamic markers of lete-cel response that may inform LDR, cell dose, and strategies to enhance anticancer efficacy.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), letetresgene autoleucel (GSK3377794) / Adaptimmune
Enrollment closed, Metastases: Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab (clinicaltrials.gov) - Jan 19, 2022 P1b/2a, N=54, Active, not recruiting, Active, not recruiting --> Completed | Trial completion date: Aug 2022 --> Mar 2022 Recruiting --> Active, not recruiting
- |||||||||| GSK3845097 / GSK, letetresgene autoleucel (GSK3377794) / GSK, ADP-A2M10 / Adaptimmune
Journal: Engineering Cancer Antigen-Specific T Cells to Overcome the Immunosuppressive Effects of TGF-β. (Pubmed Central) - Jan 12, 2022 In this article, we show that exogenous TGF-β inhibited in vitro proliferation and effector functions of human T cells expressing these first-generation high-affinity TCRs, whereas inhibition was reduced or abolished in the case of second-generation TCRs coexpressed with dnTGFβRII (e.g., GSK3845097)...As an example, immunohistochemistry/RNAscope identified TGF-β-positive cells close to T cells in tumor nests and stroma, which had low frequencies of cells expressing IFN-γ in a non-small cell lung cancer setting. Coexpression of dnTGFβRII may therefore improve the efficacy of TCR-transduced T cells.
- |||||||||| letetresgene autoleucel (GSK3377794) / Adaptimmune
Phase classification, Enrollment change, Trial completion date, Trial termination, Trial primary completion date: KEYNOTE-487: Letetresgene Autoleucel Engineered T Cells Alone and in Combination With Pembrolizumab in NY-ESO-1 Positive Multiple Myeloma (clinicaltrials.gov) - Feb 25, 2021 P1, N=6, Terminated, The substudies are open and recruiting. Phase classification: P2 --> P1 | N=20 --> 6 | Trial completion date: Jan 2023 --> Nov 2020 | Recruiting --> Terminated | Trial primary completion date: Apr 2021 --> Jul 2020; The study was terminated following an internal review of the company's research and development portfolio
|