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         headline:PSMA-targeting TGFβ-insensitive armored CAR T cells in metastatic castration-resistant prostate cancer: a phase 1 trial
         description:Chimeric antigen receptor (CAR) T cells have demonstrated promising efficacy, particularly in hematologic malignancies. One challenge regarding CAR T cells in solid tumors is the immunosuppressive tumor microenvironment (TME), characterized by high levels of multiple inhibitory factors, including transforming growth factor (TGF)-β. We report results from an in-human phase 1 trial of castration-resistant, prostate cancer-directed CAR T cells armored with a dominant-negative TGF-β receptor (NCT03089203). Primary endpoints were safety and feasibility, while secondary objectives included assessment of CAR T cell distribution, bioactivity and disease response. All prespecified endpoints were met. Eighteen patients enrolled, and 13 subjects received therapy across four dose levels. Five of the 13 patients developed grade ≥2 cytokine release syndrome (CRS), including one patient who experienced a marked clonal CAR T cell expansion, >98% reduction in prostate-specific antigen (PSA) and death following grade 4 CRS with concurrent sepsis. Acute increases in inflammatory cytokines correlated with manageable high-grade CRS events. Three additional patients achieved a PSA reduction of ≥30%, with CAR T cell failure accompanied by upregulation of multiple TME-localized inhibitory molecules following adoptive cell transfer. CAR T cell kinetics revealed expansion in blood and tumor trafficking. Thus, clinical application of TGF-β-resistant CAR T cells is feasible and generally safe. Future studies should use superior multipronged approaches against the TME to improve outcomes. CAR T cells targeting PSMA and engineered to be resistant to immunosuppressive TGFβ signaling exhibit dose-dependent toxicity and expansion following infusion, with some transient antitumor activity, in patients with metastatic castration-resistant prostate cancer
         datePublished:2022-03-21T00:00:00Z
         dateModified:2022-03-21T00:00:00Z
         pageStart:724
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            Cancer immunotherapy
            Phase I trials
            Prostate cancer
            T cells
            Tumour immunology
            Biomedicine
            general
            Cancer Research
            Metabolic Diseases
            Infectious Diseases
            Molecular Medicine
            Neurosciences
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      headline:PSMA-targeting TGFβ-insensitive armored CAR T cells in metastatic castration-resistant prostate cancer: a phase 1 trial
      description:Chimeric antigen receptor (CAR) T cells have demonstrated promising efficacy, particularly in hematologic malignancies. One challenge regarding CAR T cells in solid tumors is the immunosuppressive tumor microenvironment (TME), characterized by high levels of multiple inhibitory factors, including transforming growth factor (TGF)-β. We report results from an in-human phase 1 trial of castration-resistant, prostate cancer-directed CAR T cells armored with a dominant-negative TGF-β receptor (NCT03089203). Primary endpoints were safety and feasibility, while secondary objectives included assessment of CAR T cell distribution, bioactivity and disease response. All prespecified endpoints were met. Eighteen patients enrolled, and 13 subjects received therapy across four dose levels. Five of the 13 patients developed grade ≥2 cytokine release syndrome (CRS), including one patient who experienced a marked clonal CAR T cell expansion, >98% reduction in prostate-specific antigen (PSA) and death following grade 4 CRS with concurrent sepsis. Acute increases in inflammatory cytokines correlated with manageable high-grade CRS events. Three additional patients achieved a PSA reduction of ≥30%, with CAR T cell failure accompanied by upregulation of multiple TME-localized inhibitory molecules following adoptive cell transfer. CAR T cell kinetics revealed expansion in blood and tumor trafficking. Thus, clinical application of TGF-β-resistant CAR T cells is feasible and generally safe. Future studies should use superior multipronged approaches against the TME to improve outcomes. CAR T cells targeting PSMA and engineered to be resistant to immunosuppressive TGFβ signaling exhibit dose-dependent toxicity and expansion following infusion, with some transient antitumor activity, in patients with metastatic castration-resistant prostate cancer
      datePublished:2022-03-21T00:00:00Z
      dateModified:2022-03-21T00:00:00Z
      pageStart:724
      pageEnd:734
      sameAs:https://doi.org/10.1038/s41591-022-01726-1
      keywords:
         Cancer immunotherapy
         Phase I trials
         Prostate cancer
         T cells
         Tumour immunology
         Biomedicine
         general
         Cancer Research
         Metabolic Diseases
         Infectious Diseases
         Molecular Medicine
         Neurosciences
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      name:Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Parker Institute for Cancer Immunotherapy, University of Pennsylvania, Philadelphia, USA
      name:Division of Oncology, Children’s Hospital of Philadelphia, Philadelphia, USA
      name:Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Department of Radiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Department of Radiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:NanoString Technologies, Inc., Seattle, USA
      name:NanoString Technologies, Inc., Seattle, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Parker Institute for Cancer Immunotherapy, University of Pennsylvania, Philadelphia, USA
      name:Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Parker Institute for Cancer Immunotherapy, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Parker Institute for Cancer Immunotherapy, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Parker Institute for Cancer Immunotherapy, University of Pennsylvania, Philadelphia, USA
      name:Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Parker Institute for Cancer Immunotherapy, University of Pennsylvania, Philadelphia, USA
      name:Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
      name:Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
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