MX354371B - Régimen de dosificación para administrar un anticuerpo biespecífico cd19xcd3 a pacientes en riesgo de efectos adversos potenciales. - Google Patents

Régimen de dosificación para administrar un anticuerpo biespecífico cd19xcd3 a pacientes en riesgo de efectos adversos potenciales.

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Publication number
MX354371B
MX354371B MX2013012448A MX2013012448A MX354371B MX 354371 B MX354371 B MX 354371B MX 2013012448 A MX2013012448 A MX 2013012448A MX 2013012448 A MX2013012448 A MX 2013012448A MX 354371 B MX354371 B MX 354371B
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Mexico
Prior art keywords
dose
patient
antibody
bispecific antibody
administering
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MX2013012448A
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English (en)
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MX2013012448A (es
Inventor
Dirk Nagorsen
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Amgen Res Munich Gmbh
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Publication of MX2013012448A publication Critical patent/MX2013012448A/es
Publication of MX354371B publication Critical patent/MX354371B/es

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    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
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    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
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    • C07ORGANIC CHEMISTRY
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    • C07K16/46Hybrid immunoglobulins
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
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    • C07K2317/62Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622Single chain antibody (scFv)
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/50Determining the risk of developing a disease
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/52Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

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Abstract

La presente invención se refiere a un método para determinar (analizar) el riesgo de efectos adversos potenciales para un paciente humano moderado por la administración de un anticuerpo bisespecífico de CD19xCD3 al paciente, que comprende determinar la proporción de células B a células T del paciente, en donde una proporción de alrededor de 1:5 o más baja es indicadora de un riesgo de efectos adversos potenciales para el paciente o determinar el conteo de célula B total del paciente, en donde un conteo de célula B total de menos de alrededor de 50 células B por microlitro de sangre periférica es indicador de riesgo de efectos adversos potenciales para el paciente. Así, la presente invención es concerniente con un método (régimen de dosificación) para administrar un anticuerpo bisespecífico de CD19xCD3 a un paciente humano que tiene una proporción de células B:T de alrededor de 1:5 o más baja y/o un conteo de célula B total de menos de alrededor de 50 células B por microlitro de sangre periférica, que comprende (a) administrar una primera dosis del anticuerpo por un primer período de tiempo; y consecutivamente (b) administrar una segunda dosis del anticuerpo por un segundo período de tiempo, en donde la segunda dosis excede la primera dosis. En algunas modalidades, una tercera dosis del anticuerpo es administrada por un tercer período de tiempo. Este régimen de dosificación puede ser aplicado en métodos para el tratamiento de linfocitos CD19 positivos malignos o para mejorar y/o impedir un efecto adverso moderado por la administración de dicho anticuerpo bisespecífico. La presente invención también es concerniente con el uso de un anticuerpo bisespecífico de CD19xCD3 para la preparación de una composición farmacéutica a ser usada en un método de la presente invención. Un empaque o kit farmacéutico que comprende una primera dosis y una segunda dosis y opcionalmente una tercera dosis de dicho anticuerpo como se define en los métodos/régimen de dosificación de la presente invención es revelado también.
MX2013012448A 2011-04-28 2012-04-30 Régimen de dosificación para administrar un anticuerpo biespecífico cd19xcd3 a pacientes en riesgo de efectos adversos potenciales. MX354371B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161479961P 2011-04-28 2011-04-28
PCT/EP2012/001857 WO2012146394A1 (en) 2011-04-28 2012-04-30 Dosage regimen for administering a cd19xcd3 bispecific antibody to patients at risk for potential adverse effects

Publications (2)

Publication Number Publication Date
MX2013012448A MX2013012448A (es) 2014-02-27
MX354371B true MX354371B (es) 2018-02-28

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US (2) US10191034B2 (es)
EP (2) EP3753572A1 (es)
JP (2) JP6276175B2 (es)
KR (2) KR102345943B1 (es)
CN (2) CN107303387A (es)
AU (2) AU2012247762B2 (es)
CA (1) CA2832360C (es)
ES (1) ES2806142T3 (es)
MX (1) MX354371B (es)
WO (1) WO2012146394A1 (es)

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KR102147533B1 (ko) 2020-08-25
WO2012146394A1 (en) 2012-11-01
AU2017218919A1 (en) 2017-09-07
US11579142B2 (en) 2023-02-14
CN107303387A (zh) 2017-10-31
CA2832360A1 (en) 2012-11-01
AU2012247762A1 (en) 2013-10-17
US20190293635A1 (en) 2019-09-26
US20140199307A1 (en) 2014-07-17
KR102345943B1 (ko) 2021-12-31
CA2832360C (en) 2022-05-03
KR20200104415A (ko) 2020-09-03
US10191034B2 (en) 2019-01-29
JP2014513088A (ja) 2014-05-29
JP2018046824A (ja) 2018-03-29
JP6276175B2 (ja) 2018-02-07
EP2701741B1 (en) 2020-06-10
EP3753572A1 (en) 2020-12-23
AU2012247762B2 (en) 2017-07-06
ES2806142T3 (es) 2021-02-16
MX2013012448A (es) 2014-02-27
JP6539709B2 (ja) 2019-07-03
KR20140043350A (ko) 2014-04-09
EP2701741A1 (en) 2014-03-05
CN103648529A (zh) 2014-03-19

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Publication Publication Date Title
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