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    DOSAGE REGIMEN FOR ADMINISTERING A CD19XCD3 BISPECIFIC ANTIBODY
    2.
    发明申请
    DOSAGE REGIMEN FOR ADMINISTERING A CD19XCD3 BISPECIFIC ANTIBODY 有权
    用于管理CD19XCD3双相抗体的剂量计

    公开(公告)号：US20120328618A1

    公开(公告)日：2012-12-27

    申请号：US13504665

    申请日：2010-10-27

    申请人： Dirk Nagorsen ,  Peter Kufer ,  Gerbach Zugmaier ,  Patrick Baeuerle

    发明人： Dirk Nagorsen ,  Peter Kufer ,  Gerbach Zugmaier ,  Patrick Baeuerle

    IPC分类号： A61K39/395 ,  A61P35/02 ,  A61P35/00

    CPC分类号： C07K16/2809 ,  A61K2039/505 ,  A61K2039/545 ,  A61K2039/55 ,  C07K16/2803 ,  C07K2317/31 ,  G01N33/505 ,  G01N33/5052 ,  G01N33/5094 ,  G01N2800/52

    摘要： The present invention relates to a method for assessing (analyzing) the risk of potential adverse effects for a human patient mediated by the administration of a CD19×CD3 bispecific antibody to said patient comprising determining the ratio of B cells to T cells of said patient, wherein a ratio of about 1:5 or lower is indicative for a risk of potential adverse effects for said patient. Accordingly, the present invention relates a method (dosage regimen) for administering a CD19×CD3 bispecific antibody to a human patient having a B:T cell ratio of about 1:5 or lower, comprising (a) administering a first dose of said antibody for a first period of time; and consecutively (b) administering a second dose of said antibody for a second period of time, wherein said second dose exceeds said first dose.In some embodiments, a third dose of said antibody is administered for a third period of time. This dosage regimen can be applied in methods for treating malignant CD19 positive lymphocytes or for ameliorating and/or preventing an adverse effect mediated by the administration of said bispecific antibody. The present invention also relates to the use of a CD19×CD3 bispecific antibody for the preparation of a pharmaceutical composition to be used in a method of the present invention. A pharmaceutical package or kit comprising a first dose and a second dose and optionally a third dose of said antibody as defined in the methods/dosage regimen of the present invention is disclosed as well.

    摘要翻译： 本发明涉及用于评估（分析）通过向所述患者施用CD19×CD3双特异性抗体介导的人类患者的潜在不良反应的风险的方法，包括确定所述患者的B细胞与T细胞的比率， 其中约1:5或更低的比率指示对所述患者具有潜在不利影响的风险。 因此，本发明涉及用于向B：T细胞比例为约1:5或更低的人类患者施用CD19×CD3双特异性抗体的方法（剂量方案），其包括（a）施用第一剂量的所述抗体 第一段时间; 并且连续地（b）在第二时间段内施用第二剂量的所述抗体，其中所述第二剂量超过所述第一剂量。在一些实施方案中，所述抗体的第三剂量施用第三时间段。 该给药方案可以用于治疗恶性CD19阳性淋巴细胞的方法或用于改善和/或预防由所述双特异性抗体施用介导的不良作用。 本发明还涉及CD19×CD3双特异性抗体用于制备用于本发明方法的药物组合物的用途。 还公开了包含本发明的方法/剂量方案中定义的第一剂量和第二剂量以及任选地第三剂量的所述抗体的药物包装或试剂盒。

    DOSAGE REGIMEN FOR ADMINISTERING A CD19XCD3 BISPECIFIC ANTIBODY TO PATIENTS AT RISK FOR POTENTIAL ADVERSE EFFECTS
    4.
    发明申请
    DOSAGE REGIMEN FOR ADMINISTERING A CD19XCD3 BISPECIFIC ANTIBODY TO PATIENTS AT RISK FOR POTENTIAL ADVERSE EFFECTS 审中-公开
    用于管理CD19XCD3双相抗体的剂量方案对患有潜在不良反应的风险患者

    公开(公告)号：US20140199307A1

    公开(公告)日：2014-07-17

    申请号：US14113755

    申请日：2012-04-30

    申请人： Dirk Nagorsen

    发明人： Dirk Nagorsen

    IPC分类号： C07K16/28 ,  G01N33/50

    CPC分类号： G01N33/5094 ,  A61K2039/505 ,  A61K2039/507 ,  C07K16/2803 ,  C07K16/2809 ,  C07K2317/31 ,  C07K2317/622 ,  G01N33/5005 ,  G01N2800/50

    摘要： The present invention relates to a method for assessing (analyzing) the risk of potential adverse effects for a human patient mediated by the administration of a CD19xCD3 bispecific antibody to said patient comprising determining the ratio of B cells to T cells of said patient, wherein a ratio of about 1:5 or lower is indicative for a risk of potential adverse effects for said patient or determining the total B cell count of said patient, wherein a total B cell count of less than about 50 B cells per microliter of peripheral blood is indicative for a risk of potential adverse effects for said patient. Accordingly, the present invention relates a method (dosage regimen) for administering a CD19xCD3 bispecific antibody to a human patient having a B:T cell ratio of about 1:5 or lower and/or a total B cell count of less than about 50 B cells per microliter of peripheral blood, comprising (a) administering a first dose of said antibody for a first period of time; and consecutively (b) administering a second dose of said antibody for a second period of time, wherein said second dose exceeds said first dose. In some embodiments, a third dose of said antibody is administered for a third period of time. This dosage regimen can be applied in methods for treating malignant CD19 positive lymphocytes or for ameliorating and/or preventing an adverse effect mediated by the administration of said bispecific antibody. The present invention also relates to the use of a CD19xCD3 bispecific antibody for the preparation of a pharmaceutical composition to be used in a method of the present invention. A pharmaceutical package or kit comprising a first dose and a second dose and optionally a third dose of said antibody as defined in the methods/dosage regimen of the present invention is disclosed as well.

    摘要翻译： 本发明涉及用于评估（分析）通过向所述患者施用CD19xCD3双特异性抗体介导的人类患者的潜在不良反应的风险的方法，包括确定所述患者的B细胞与T细胞的比例，其中a 约1:5或更低的比率指示对所述患者具有潜在不利影响的风险或确定所述患者的总B细胞计数，其中每微升外周血小于约50B细胞的总B细胞计数为 指示对所述患者具有潜在不利影响的风险。 因此，本发明涉及用于对B：T细胞比例为约1:5或更低和/或总B细胞计数小于约50B的人类患者施用CD19xCD3双特异性抗体的方法（剂量方案） 每微升外周血的细胞，包括（a）在第一时间段内施用第一剂量的所述抗体; 并连续地（b）在第二时间段内施用第二剂量的所述抗体，其中所述第二剂量超过所述第一剂量。 在一些实施方案中，施用第三剂量的所述抗体持续第三个时间段。 该给药方案可以用于治疗恶性CD19阳性淋巴细胞的方法或用于改善和/或预防由所述双特异性抗体施用介导的不良作用。 本发明还涉及CD19xCD3双特异性抗体用于制备用于本发明方法的药物组合物的用途。 还公开了包含本发明的方法/剂量方案中定义的第一剂量和第二剂量以及任选地第三剂量的所述抗体的药物包装或试剂盒。

    Means and methods for treating DLBCL
    5.
    发明授权
    Means and methods for treating DLBCL 有权
    治疗DLBCL的方法和方法

    公开(公告)号：US09192665B2

    公开(公告)日：2015-11-24

    申请号：US13881889

    申请日：2011-10-27

    申请人： Gerhard Zugmaier ,  Dirk Nagorsen ,  Juergen Scheele

    发明人： Gerhard Zugmaier ,  Dirk Nagorsen ,  Juergen Scheele

    IPC分类号： A61K39/395 ,  C07K16/28 ,  A61K39/00

    CPC分类号： C07K16/2809 ,  A61K39/39558 ,  A61K2039/505 ,  A61K2039/545 ,  C07K16/2803 ,  C07K2317/31 ,  C07K2317/76

    摘要： The present invention provides means and methods for treating diffuse large B cell lymphoma (DLBCL). Specifically, a bispecific CD19×CD3 antibody which engages T cells via its CD3 binding portion and concomitantly binds to CD19 on the surface of in particular, lymphoma cells via its CD19 binding portion (i.e. a bispecific T cell engager, “BiTE”) is administered for use in the treatment of tumorous mass of lymophoreticular tissue and/or extranodal lymphoma caused by DLBCL in a patient.

    摘要翻译： 本发明提供了治疗弥漫性大B细胞淋巴瘤（DLBCL）的方法和方法。 具体地，施用通过其CD3结合部分与T细胞接合并通过其CD19结合部分特别是淋巴瘤细胞表面（即，双特异性T细胞募集体“BiTE”）同时结合CD19的双特异性CD19×CD3抗体） 用于治疗由DLBCL引起的淋巴管组织和/或结外淋巴瘤的肿瘤组织。

    Dosage regimen for administrating a CD19×CD3 bispecific antibody to patients at risk for potential adverse effects
    7.
    发明授权
    Dosage regimen for administrating a CD19×CD3 bispecific antibody to patients at risk for potential adverse effects 有权

    公开(公告)号：US10191034B2

    公开(公告)日：2019-01-29

    申请号：US14113755

    申请日：2012-04-30

    申请人： Dirk Nagorsen

    发明人： Dirk Nagorsen

    IPC分类号： G01N33/50 ,  C07K16/28 ,  A61K39/00

    摘要： A method for assessing the risk of potential adverse effects for a human patient receiving a CD19×CD3 bispecific antibody is provided. The method comprises determining the total B count in the patient, and identifying a B cell number indicative of a patient at risk of potential adverse effects from the antibody. The method further provides a dosing schedule for administering the antibody to the patient identified as at risk of potential adverse effects. Also provided is a pharmaceutical package or kit comprising a first dose and a second dose, and optionally a third dose, of the CD19×CD3 bispecific antibody as defined in the methods/dosage regimen of the disclosure.

    MEANS AND METHODS FOR TREATING DLBCL
    8.
    发明申请
    MEANS AND METHODS FOR TREATING DLBCL 有权
    治疗DLBCL的方法和方法

    公开(公告)号：US20130287778A1

    公开(公告)日：2013-10-31

    申请号：US13881889

    申请日：2011-10-27

    申请人： Gerhard Zugmaier ,  Dirk Nagorsen ,  Juergen Scheele

    发明人： Gerhard Zugmaier ,  Dirk Nagorsen ,  Juergen Scheele

    IPC分类号： A61K39/395

    CPC分类号： C07K16/2809 ,  A61K39/39558 ,  A61K2039/505 ,  A61K2039/545 ,  C07K16/2803 ,  C07K2317/31 ,  C07K2317/76

    摘要： The present invention provides means and methods for treating diffuse large B cell lymphoma (DLBCL). Specifically, a bispecific CD19×CD3 antibody which engages T cells via its CD3 binding portion and concomitantly binds to CD19 on the surface of in particular, lymphoma cells via its CD19 binding portion (i.e. a bispecific T cell engager, “BiTE”) is administered for use in the treatment of tumorous mass of lymophoreticular tissue and/or extranodal lymphoma caused by DLBCL in a patient.

    摘要翻译： 本发明提供了治疗弥漫性大B细胞淋巴瘤（DLBCL）的方法和方法。 具体地，施用通过其CD3结合部分与T细胞接合并通过其CD19结合部分特别是淋巴瘤细胞表面（即双特异性T细胞募集体“BiTE”）并与CD19结合的双特异性CD19×CD3抗体） 用于治疗由DLBCL引起的淋巴管组织和/或结外淋巴瘤的肿瘤组织。