MX2012004880A - Pauta posologica para adminitrar un anticuerpo biespecifico cd19xcd3. - Google Patents
Pauta posologica para adminitrar un anticuerpo biespecifico cd19xcd3.Info
- Publication number
- MX2012004880A MX2012004880A MX2012004880A MX2012004880A MX2012004880A MX 2012004880 A MX2012004880 A MX 2012004880A MX 2012004880 A MX2012004880 A MX 2012004880A MX 2012004880 A MX2012004880 A MX 2012004880A MX 2012004880 A MX2012004880 A MX 2012004880A
- Authority
- MX
- Mexico
- Prior art keywords
- dose
- antibody
- administering
- bispecific antibody
- dosage regimen
- Prior art date
Links
- 230000002411 adverse Effects 0.000 abstract 3
- 230000000694 effects Effects 0.000 abstract 3
- 210000001744 T-lymphocyte Anatomy 0.000 abstract 2
- 230000001404 mediated effect Effects 0.000 abstract 2
- 102100024222 B-lymphocyte antigen CD19 Human genes 0.000 abstract 1
- 101000980825 Homo sapiens B-lymphocyte antigen CD19 Proteins 0.000 abstract 1
- 210000003719 b-lymphocyte Anatomy 0.000 abstract 1
- 210000004698 lymphocyte Anatomy 0.000 abstract 1
- 230000003211 malignant effect Effects 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IGs], 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
- C07K16/2809—Immunoglobulins [IGs], 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IGs], 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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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
- G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
- G01N33/5044—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics involving specific cell types
- G01N33/5047—Cells of the immune system
- G01N33/505—Cells of the immune system involving T-cells
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
- G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
- G01N33/5044—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics involving specific cell types
- G01N33/5047—Cells of the immune system
- G01N33/5052—Cells of the immune system involving B-cells
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
- G01N33/5094—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for blood cell populations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
Landscapes
- Health & Medical Sciences (AREA)
- Immunology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Cell Biology (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Microbiology (AREA)
- Physics & Mathematics (AREA)
- Food Science & Technology (AREA)
- Pathology (AREA)
- General Physics & Mathematics (AREA)
- Tropical Medicine & Parasitology (AREA)
- Biotechnology (AREA)
- Analytical Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Toxicology (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Ecology (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Oncology (AREA)
Abstract
La presente invención se relaciona con un método para evaluar (analizar) el riesgo de reacciones adversas potenciales para un paciente humano, mediado por la administración de un anticuerpo biespecífico CD19xCD3 al paciente que comprende determinar la proporción de linfocitos B con respecto a linfocitos T del paciente mencionado, donde una proporción de aproximadamente 1:5 o menos es indicativo de un riesgo de potenciales reacciones adversas para el paciente mencionado. En consecuencia, la presente invención se relacionan con un método (pauta posológica) para administrar un anticuerpo biespecífico CD19xCD3 a un paciente humano que tiene una proporción de células B:T de aproximadamente 1:5 o menos, que comprende (a) administrar una primera dosis del anticuerpo durante un primer período de tiempo; y consecutivamente (b) administrar una segunda dosis del anticuerpo durante un segundo período de tiempo, donde la segunda dosis excede a la primera dosis. En algunas modalidades, una tercera dosis del anticuerpo se administra durante un tercer período de tiempo. Esta pauta posológica puede aplicarse en métodos para tratar los linfocitos CD19 con resultado positivo de neoplasia maligna o para mejorar y/o prevenir una reacción adversa regulada por la administración del anticuerpo biespecífico mencionado. La presente invención también se relaciona con el uso de un anticuerpo biespecífico CD19xCD3 para la preparación de una composición farmacéutica para usarse en un método de la presente invención. También se describe el envase farmacéutico o el kit que comprende una primera dosis y una segunda dosis y opcionalmente una tercera dosis del anticuerpo como se define en los métodos/pauta posológica de la presente invención.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US25529009P | 2009-10-27 | 2009-10-27 | |
| EP09174104 | 2009-10-27 | ||
| PCT/EP2010/066207 WO2011051307A1 (en) | 2009-10-27 | 2010-10-27 | Dosage regimen for administering a cd19xcd3 bispecific antibody |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2012004880A true MX2012004880A (es) | 2012-05-23 |
Family
ID=43921378
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2012004880A MX2012004880A (es) | 2009-10-27 | 2010-10-27 | Pauta posologica para adminitrar un anticuerpo biespecifico cd19xcd3. |
Country Status (26)
| Country | Link |
|---|---|
| US (2) | US8840888B2 (es) |
| EP (1) | EP2493503B2 (es) |
| JP (2) | JP6092625B2 (es) |
| KR (2) | KR101841781B1 (es) |
| CN (2) | CN102711822A (es) |
| AU (1) | AU2010311559B2 (es) |
| BR (1) | BR112012009778A2 (es) |
| CA (1) | CA2774919C (es) |
| CY (1) | CY1116874T1 (es) |
| DK (1) | DK2493503T4 (es) |
| ES (1) | ES2552655T5 (es) |
| HR (1) | HRP20151196T4 (es) |
| HU (1) | HUE025759T2 (es) |
| IL (1) | IL219301A (es) |
| ME (1) | ME02947B (es) |
| MX (1) | MX2012004880A (es) |
| NZ (1) | NZ598732A (es) |
| PL (1) | PL2493503T5 (es) |
| PT (1) | PT2493503E (es) |
| RS (1) | RS54655B2 (es) |
| RU (1) | RU2548746C2 (es) |
| SG (2) | SG10201406533RA (es) |
| SI (1) | SI2493503T2 (es) |
| SM (1) | SMT201500267B (es) |
| WO (1) | WO2011051307A1 (es) |
| ZA (1) | ZA201201774B (es) |
Families Citing this family (71)
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| EP2342227B1 (en) * | 2008-11-07 | 2015-10-07 | Amgen Research (Munich) GmbH | Treatment of acute lymphoblastic leukemia |
| ES2535257T3 (es) * | 2008-11-07 | 2015-05-07 | Amgen Research (Munich) Gmbh | Tratamiento de leucemia linfoblástica aguda pediátrica |
| MX2012004880A (es) * | 2009-10-27 | 2012-05-23 | Micromet Ag | Pauta posologica para adminitrar un anticuerpo biespecifico cd19xcd3. |
| SI2632954T2 (sl) * | 2010-10-27 | 2021-11-30 | Amgen Research (Munich) Gmbh | Sredstva in postopki za zdravljenje dlbcl |
| JP6023717B2 (ja) | 2010-11-10 | 2016-11-09 | アムジェン リサーチ （ミュニック） ゲゼルシャフト ミット ベシュレンクテル ハフツング | Ｃｄ３特異的結合ドメインによって引き起こされる有害作用の予防 |
| AU2012247762B2 (en) * | 2011-04-28 | 2017-07-06 | Amgen Research (Munich) Gmbh | Dosage regimen for administering a CD19xCD3 bispecific antibody to patients at risk for potential adverse effects |
| US12466897B2 (en) | 2011-10-10 | 2025-11-11 | Xencor, Inc. | Heterodimeric human IgG1 polypeptides with isoelectric point modifications |
| CN110981964B (zh) * | 2013-01-14 | 2023-09-15 | Xencor股份有限公司 | 新型异二聚体蛋白 |
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| JPH02500329A (ja) | 1987-05-21 | 1990-02-08 | クリエイテイブ・バイオマリキユールズ・インコーポレーテツド | ターゲット化多機能蛋白質 |
| HRP20000714B1 (en) | 1998-04-21 | 2006-03-31 | Micromet Ag | NOVEL CD19xCD3 SPECIFIC POLYPEPTIDES AND USES THEREOF |
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| PT2520590T (pt) | 2007-04-03 | 2018-11-14 | Amgen Res Munich Gmbh | Domínio de ligação específico de espécies cruzadas |
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