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    DRUG:

    EGFR806-specific CAR T-cell therapy

    i
    Other names: EGFR806-specific chimeric antigen receptor (CAR) T cell therapy, second generation 4-1BBζ EGFR806-EGFRt, EGFR806-specific CAR T-cell therapy
    Company:
    Cellevolve Bio, Seattle Children's Hospital, Seattle Children’s Therapeutics
    Drug class:
    EGFR-targeted CAR-T immunotherapy
    Related drugs:
    4d
    Chimeric Antigen Receptor-T Cell Therapy for Pediatric and Young Adult Primary Central Nervous System Tumors: A Systematic Review of Early Phase Clinical Trials with a Focus on Diffuse Midline Glioma. (PubMed, Target Oncol)
    Preliminary clinical experience indicates that CAR-T cell therapy for pediatric and young adult CNS tumors is biologically active and clinically feasible, exhibiting a distinct yet manageable toxicity profile. Although durable objective responses are currently limited, the frequent occurrence of disease stabilization and extended survival in certain patients substantiate ongoing research and the refinement of CAR-T cell strategies for CNS malignancies.
    Review • Journal
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR806-specific CAR T-cell therapy
    7ms
    Study of B7-H3, EGFR806, HER2, And IL13-Zetakine (Quad) CAR T Cell Locoregional Immunotherapy For Pediatric Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, And Recurrent Or Refractory Central Nervous System Tumors (clinicaltrials.gov)
    P1, N=72, Active, not recruiting, Seattle Children's Hospital | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    EGFR806-specific CAR T-cell therapy • SC-CAR4BRAIN
    7ms
    STRIvE-01: EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults (clinicaltrials.gov)
    P1, N=44, Active, not recruiting, Seattle Children's Hospital | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2025 --> Jun 2040
    Enrollment closed • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    EGFR806-specific CAR T-cell therapy • SCRI-CARB7H3(s)x19
    over1year
    Locoregional Infusion of EGFR806-CAR T Cells for Recurrent or Refractory Pediatric CNS Tumors: Results of the Completed BrainChild02 Phase 1 Clinical Trial. (PubMed, Neuro Oncol)
    Intracranially infused EGFR806-CAR T cells were tolerable at tested doses, with a best response of stable disease. EGFR is a potentially useful target for cellular therapy against pediatric brain tumors, particularly high-grade gliomas.
    P1 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR expression • EGFR wild-type
    |
    EGFR806-specific CAR T-cell therapy • depatuxizumab (ABT-806)
    over1year
    EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric CNS Tumors (clinicaltrials.gov)
    P1, N=11, Completed, Seattle Children's Hospital | Active, not recruiting --> Completed | Trial completion date: Mar 2040 --> Dec 2023 | Trial primary completion date: Mar 2025 --> Dec 2023
    Trial completion • Trial completion date • Trial primary completion date • CAR T-Cell Therapy • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR positive
    |
    EGFR806-specific CAR T-cell therapy
    2years
    STRIvE-01: EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults (clinicaltrials.gov)
    P1, N=44, Recruiting, Seattle Children's Hospital | Trial completion date: Jun 2038 --> Jun 2040 | Trial primary completion date: Jun 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    EGFR806-specific CAR T-cell therapy • SCRI-CARB7H3(s)x19
    almost3years
    STRIvE-01: EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults (clinicaltrials.gov)
    P1, N=44, Recruiting, Seattle Children's Hospital | Trial primary completion date: Jun 2023 --> Jun 2024
    Trial primary completion date • CAR T-Cell Therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    EGFR806-specific CAR T-cell therapy
    3years
    Study of B7-H3, EGFR806, HER2, And IL13-Zetakine (Quad) CAR T Cell Locoregional Immunotherapy For Pediatric Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, And Recurrent Or Refractory Central Nervous System Tumors (clinicaltrials.gov)
    P1, N=72, Recruiting, Seattle Children's Hospital | Not yet recruiting --> Recruiting
    Enrollment open • CAR T-Cell Therapy
    |
    EGFR806-specific CAR T-cell therapy • SC-CAR4BRAIN
    over3years
    EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric CNS Tumors (clinicaltrials.gov)
    P1, N=11, Active, not recruiting, Seattle Children's Hospital | Recruiting --> Active, not recruiting | N=36 --> 11
    Enrollment closed • Enrollment change • CAR T-Cell Therapy • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression • EGFR positive
    |
    EGFR806-specific CAR T-cell therapy
    over3years
    EGFR as a potent CAR T target in triple negative breast cancer brain metastases. (PubMed, Breast Cancer Res Treat)
    Our results demonstrates anti-tumor activity of EGFR806 CAR T cells against TNBC cells in vitro and in vivo. Given EGFR806 CAR T cells are currently undergoing clinical trials in primary brain tumor patients without obvious toxicity, our results are immediately actionable against the TNBC-BM patient population.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR806-specific CAR T-cell therapy • depatuxizumab (ABT-806)
    5years
    EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults (clinicaltrials.gov)
    P1, N=36, Recruiting, Seattle Children's Hospital | Trial completion date: Jun 2036 --> Jun 2038 | Trial primary completion date: Jun 2021 --> Jun 2023
    Clinical • Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    EGFR (Epidermal growth factor receptor) • CD19 (CD19 Molecule)
    |
    EGFR expression
    |
    EGFR806-specific CAR T-cell therapy