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    DRUG:

    BRL-201

    i
    Other names: BRL-201, PD1 targeting integrated CD19 CART, Quikin CD19-CART, PD1-CD19-CART, CD19-Specific Chimeric Antigen Receptor T cells with PD1 knockout, BRL201, BRL 201
    Company:
    BRL Medicine
    Drug class:
    PD1 inhibitor, CD19-targeted CAR-T immunotherapy
    Related drugs:
    11ms
    The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=18, Recruiting, Bioray Laboratories | Not yet recruiting --> Recruiting | Phase classification: P1/2 --> P1
    Enrollment open • Phase classification • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    BRL-201
    11ms
    2019-CAR-00CH1: PD1-CD19-CART in Patients With r/r B-cell Lymphoma (clinicaltrials.gov)
    P=N/A, N=20, Completed, Bioray Laboratories | Active, not recruiting --> Completed | Trial completion date: Apr 2023 --> Nov 2023
    Trial completion • Trial completion date
    |
    cyclophosphamide • BRL-201
    1year
    Long Term Follow-up Results of Brl-201 Phase I Study, a Crispr-Based Non-Viral PD-1 Locus Specific Integrated Anti-CD19 CAR-T Cells in Treating Relapsed or Refractory Non-Hodgkin's Lymphoma (ASH 2023)
    Adult patients with r/r B-NHL underwent leukapheresis and a lymphodepletion chemotherapy with cyclophosphamide (500mg/m2, D -3 to -2) and fludarabine (30mg/m2, D -4 to -2) before BRL-201 infusion...14 patients (66.7%) experienced grade 1-2 cytokine release syndrome (CRS) and only one patient received tocilizumab... Over a median follow up of 29 months, BRL-201 was demonstrated durable response with a high median PFS of 20.8 months and 12-month OS rate of 76.2%. The median OS was not reached yet for responding patients, and the safety profile was manageable. More data will be collected to prove the value of clinical usage of BRL-201.
    P1 data • CAR T-Cell Therapy • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression
    |
    cyclophosphamide • fludarabine IV • Actemra IV (tocilizumab) • BRL-201
    1year
    High safety and efficacy of CRISPR-Based non-viral PD1 locus specific Integrated Anti-CD19 CAR-T cells (BRL-201) in treating relapsed or refractory non-Hodgkin’s lymphoma: first-in-human phase I study (SITC 2023)
    Methods Adult patients with r/r B-NHL underwent leukapheresis and a lymphodepletion chemotherapy with cyclophosphamide (500mg/m2, D -3 to -2) and fludarabine (30mg/m2, D -4 to -2) before BRL-201 infusion...7%) experienced grade 1–2 cytokine release syndrome (CRS) and only one patient received tocilizumab...2%, and a manageable safety profile. These data continues supporting the compelling clinical benefit-risk profile of BRL-201for r/r B-NHL patients.
    Clinical • P1 data • CAR T-Cell Therapy
    |
    PD-1 (Programmed cell death 1)
    |
    cyclophosphamide • fludarabine IV • Actemra IV (tocilizumab) • BRL-201
    over1year
    The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=18, Not yet recruiting, Bioray Laboratories
    New P1/2 trial • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    BRL-201
    2years
    High Safety and Efficacy of CRISPR-Based Non-Viral PD-1 Locus Specific Integrated Anti-CD19 CAR-T Cells (BRL-201) in Treating Relapsed or Refractory Non-Hodgkin's Lymphoma: First-in-Human Phase I Study (ASH 2022)
    Adult patients with r/r B-NHL underwent leukapheresis and a lymphodepletion chemotherapy with cyclophosphamide (500mg/m2 , D -3 to -2) and fludarabine (30mg/m2, D -4 to -2) before BRL-201 infusion...Fourteen patients (66.7%) experienced low grade (1 or 2) cytokine release syndrome (CRS) and only one patient received tocilizumab... This is a first-in-human study of a novel type of non-viral genome specific targeted CAR-T cells in treating r/r B-NHL. As a two-in-one approach without using virus, the manufacturing procedure is simplified, with shortened preparation time, reduced production expenses. Low incidence and mild grade of CRS/ICANS preliminarily showed the high safety of BRL-201.
    Clinical • P1 data • CAR T-Cell Therapy • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression
    |
    cyclophosphamide • fludarabine IV • Actemra IV (tocilizumab) • BRL-201
    over2years
    PD1-CD19-CART in Patients With r/r B-cell Lymphoma (clinicaltrials.gov)
    P=N/A, N=20, Active, not recruiting, Bioray Laboratories | Recruiting --> Active, not recruiting | Trial completion date: Apr 2022 --> Apr 2023
    Enrollment closed • Trial completion date
    |
    CD19 (CD19 Molecule)
    |
    cyclophosphamide • BRL-201