CY1116874T1 - Δοσολογικο σχημα για τη χορηγηση ενος cd19xcd3 αμφιειδικου αντισωματος - Google Patents
Δοσολογικο σχημα για τη χορηγηση ενος cd19xcd3 αμφιειδικου αντισωματοςInfo
- Publication number
- CY1116874T1 CY1116874T1 CY20151100956T CY151100956T CY1116874T1 CY 1116874 T1 CY1116874 T1 CY 1116874T1 CY 20151100956 T CY20151100956 T CY 20151100956T CY 151100956 T CY151100956 T CY 151100956T CY 1116874 T1 CY1116874 T1 CY 1116874T1
- Authority
- CY
- Cyprus
- Prior art keywords
- antibody
- dose
- cd19xcd3
- administration
- amphiphilic
- Prior art date
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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
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- 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
- 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
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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
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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
- G01N33/5094—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
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- 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)
- Food Science & Technology (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Biotechnology (AREA)
- Tropical Medicine & Parasitology (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Toxicology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Ecology (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Oncology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
Abstract
Η παρούσα εφεύρεση αναφέρεται σε μια μέθοδο για τον υπολογισμό (ανάλυση) του κινδύνου δυνητικών δυσμενών επιπτώσεων για έναν ασθενή άνθρωπο μεσολαβούμενων από τη χορήγηση ενός CD19xCD3 αμφιειδικού αντισώματος στο ρηθέντα ασθενή η οποία μέθοδος περιλαμβάνει τον καθορισμό του λόγου Β-κυττάρων προς Τ-λεμφοκύτταρα του ρηθέντος ασθενή, όπου ένας λόγος περίπου 1:5 ή χαμηλότερος είναι ενδεικτικός ενός κινδύνου δυνητικών δυσμενών επιπτώσεων για το ρηθέντα ασθενή. Αναλόγως, η παρούσα εφεύρεση αναφέρεται σε μια μέθοδο (δοσολογικό σχήμα) για τη χορήγηση ενός CD19xCD3 αμφιειδικού αντισώματος σε έναν ασθενή άνθρωπο που έχει ένα λόγο Β-κυττάρων: Τ-λεμφοκύτταρα περίπου 1:5 ή χαμηλότερο, η οποία μέθοδος περιλαμβάνει (a) χορήγηση μιας πρώτης δόσης του ρηθέντος αντισώματος για μια πρώτη χρονική περίοδο- και διαδοχικά (b) χορήγηση μιας δεύτερης δόσης του ρηθέντος αντισώματος για μια δεύτερη χρονική περίοδο, όπου η ρηθείσα δεύτερη δόση υπερβαίνει τη ρηθείσα πρώτη δόση. Σε μερικές ενσωματώσεις, μια τρίτη δόση του ρηθέντος αντισώματος χορηγείται για μια τρίτη χρονική περίοδο. Αυτό το δοσολογικό σχήμα μπορεί να εφαρμοστεί σε μεθόδους για τη θεραπεία κακοηθών CD 19 θετικών λεμφοκυττάρων ή για τη βελτίωση ή/και πρόληψη μιας δυσμενούς επίπτωσης μεσολαβούμενης από τη χορήγηση του ρηθέντος αμφιειδικού αντισώματος. Η παρούσα εφεύρεση αναφέρεται επίσης στη χρησιμοποίηση ενός CD19xCD3 αμφιειδικού αντισώματος για την παρασκευή μιας φαρμακευτικής σύνθεσης προς χρήση σε μια μέθοδο της παρούσας εφεύρεσης. Επίσης αποκαλύπτεται μια φαρμακευτική συσκευασία ή κιτίο που περιλαμβάνει μια πρώτη δόση και μια δεύτερη δόση και προαιρετικώς μια τρίτη δόση του ρηθέντος αντισώματος όπως ορίζεται στις
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US25529009P | 2009-10-27 | 2009-10-27 | |
| EP09174104 | 2009-10-27 | ||
| EP10771102.0A EP2493503B2 (en) | 2009-10-27 | 2010-10-27 | Dosage regimen for administering a cd19xcd3 bispecific antibody |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CY1116874T1 true CY1116874T1 (el) | 2017-04-05 |
Family
ID=43921378
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CY20151100956T CY1116874T1 (el) | 2009-10-27 | 2015-10-26 | Δοσολογικο σχημα για τη χορηγηση ενος cd19xcd3 αμφιειδικου αντισωματος |
Country Status (27)
| Country | Link |
|---|---|
| US (2) | US8840888B2 (el) |
| EP (1) | EP2493503B2 (el) |
| JP (2) | JP6092625B2 (el) |
| KR (2) | KR101841781B1 (el) |
| CN (2) | CN107227335A (el) |
| AU (1) | AU2010311559B2 (el) |
| BR (1) | BR112012009778A2 (el) |
| CA (1) | CA2774919C (el) |
| CY (1) | CY1116874T1 (el) |
| DK (1) | DK2493503T4 (el) |
| ES (1) | ES2552655T5 (el) |
| HK (1) | HK1172828A1 (el) |
| HR (1) | HRP20151196T4 (el) |
| HU (1) | HUE025759T2 (el) |
| IL (1) | IL219301A (el) |
| ME (1) | ME02947B (el) |
| MX (1) | MX2012004880A (el) |
| NZ (1) | NZ598732A (el) |
| PL (1) | PL2493503T5 (el) |
| PT (1) | PT2493503E (el) |
| RS (1) | RS54655B2 (el) |
| RU (1) | RU2548746C2 (el) |
| SG (2) | SG10201406533RA (el) |
| SI (1) | SI2493503T2 (el) |
| SM (1) | SMT201500267B (el) |
| WO (1) | WO2011051307A1 (el) |
| ZA (1) | ZA201201774B (el) |
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| DE3856559T2 (de) | 1987-05-21 | 2004-04-29 | Micromet Ag | Multifunktionelle Proteine mit vorbestimmter Zielsetzung |
| NZ507381A (en) * | 1998-04-21 | 2003-12-19 | Micromet Ag | CD19xCD3 specific polypeptides and uses thereof |
| AU2004242846A1 (en) * | 2003-05-31 | 2004-12-09 | Micromet Ag | Pharmaceutical compositions comprising bispecific anti-CD3, anti-CD19 antibody constructs for the treatment of B-cell related disorders |
| US7771999B2 (en) * | 2004-04-28 | 2010-08-10 | Vaxdesign Corp. | Disease model incorporation into an artificial immune system (AIS) |
| AU2006326727A1 (en) * | 2005-12-16 | 2007-06-21 | Amgen Research (Munich) Gmbh | Means and methods for the treatment of tumorous diseases |
| CN101331151A (zh) * | 2005-12-16 | 2008-12-24 | 麦克罗梅特股份公司 | 治疗肿瘤性疾病的方式和方法 |
| CN101687915B8 (zh) | 2007-04-03 | 2018-08-03 | 安进研发（慕尼黑）股份有限公司 | 跨物种特异性CD3-ε结合结构域 |
| BRPI0809594A2 (pt) | 2007-04-03 | 2019-08-27 | Micromet Ag | polipeptídeo, seqüência de ácido nucléico, vetor, hospedeiro, processo para a produção de um polipeptídeo, composição farmacêutica, uso de um polipeptídeo, método para prevenção, tratamento ou melhora de uma doença, em um indivíduo com necessidade do mesmo, kit, método para a identificação de um polipeptídeo(s) |
| ME02363B (me) | 2008-11-07 | 2016-06-20 | Amgen Res Munich Gmbh | Liječenje akutne limfoblastične leukemije |
| RS54655B2 (sr) * | 2009-10-27 | 2021-04-29 | Amgen Res Munich Gmbh | Dozni režim za primenu cd19xcd3 bispecifičnog antitela |
| JP6276175B2 (ja) | 2011-04-28 | 2018-02-07 | 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 | 潜在的有害作用リスクのある患者にＣＤ１９ｘＣＤ３二特異性抗体を投与するための投薬レジメン |
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