DK2493503T3 - Doseringsplan for administrering af et cd19xcd3-bispecifikt antistof - Google Patents
Doseringsplan for administrering af et cd19xcd3-bispecifikt antistof Download PDFInfo
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- DK2493503T3 DK2493503T3 DK10771102.0T DK10771102T DK2493503T3 DK 2493503 T3 DK2493503 T3 DK 2493503T3 DK 10771102 T DK10771102 T DK 10771102T DK 2493503 T3 DK2493503 T3 DK 2493503T3
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- C07K16/2809—Immunoglobulins [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
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- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
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- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
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- 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
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- 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
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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
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
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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
- A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
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- 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
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- 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
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Claims (21)
- DOSERINGSPLAN FOR ADMINISTRERING AF ET CD19XCD3-BISPECIFIKT ANTISTOF1. CD19xCD3-bispecifikt antistof til anvendelse i en fremgangsmåde til behandling af maligne CD19-positive lymfocytter hos en human patient, hvor patienten har et B:T-celleforhold på ca. 1:5 eller derunder, og hvor fremgangsmåden omfatter: (a) administrering af en først dosis af et CD19xCD3-bispecifikt antistof i et første tidsrum; og på hinanden følgende (b) administrering af en anden dosis af antistoffet i et andet tidsrum; hvor den anden dosis overstiger den første dosis.
- 2. CD19xCD3-bispecifikt antistof til anvendelse ifølge krav 1, hvor administrationsvejen i trin (a) og/eller administrationsvejen i trin (b) er intravenøs.
- 3. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 1 til 2, hvor det andet tidsrum overstiger det første tidsrum.
- 4. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 1 til 3, hvor det første tidsrum overstiger 3 dage, fortrinsvis det første tidsrum er mellem 3 dage og 10 dage, idet 7 dage foretrækkes.
- 5. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 1 til 4, hvor det andet tidsrum overstiger 18 dage, fortrinsvis det andet tidsrum er mellem 18 dage og 81 dage, idet 21 eller 49 dage foretrækkes.
- 6. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 1 til 5, hvor den første dosis er mellem 1 og 15 pg/m2/d, idet 5 eller 15 pg/m2/d foretrækkes.
- 7. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 1 til 6, hvor den anden dosis er mellem 15 og 60 pg/m /d, idet 60 pg/m2/d foretrækkes.
- 8. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 1 til 3, der yderligere omfatter administrering efter en første og anden dosis i et første og andet tidsrum af en tredje dosis af antistoffet i et tredje tidsrum.
- 9. CD19xCD3-bispecifikt antistof til anvendelse ifølge krav 8, hvor det tredje tidsrum overstiger det første og andet tidsrum, hvorved den anden dosis overstiger den første dosis.
- 10. CD19xCD3-bispecifikt antistof til anvendelse ifølge krav 8 eller 9, hvor det første tidsrum overstiger 3 dage, fortrinsvis det første tidsrum er mellem 3 dage og 10 dage, idet 7 dage foretrækkes.
- 11. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 8 til 10, hvor det andet tidsrum overstiger 3 dage, fortrinsvis det andet tidsrum er mellem 3 dage og 10 dage, idet 7 dage foretrækkes.
- 12. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 8 til 11, hvor det tredje tidsrum overstiger 8 dage, fortrinsvis det tredje tidsrum er mellem 8 dage og 78 dage, idet 14 eller 42 dage foretrækkes.
- 13. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 8 til 12, hvor det første tidsrum er mellem 3 dage og 10 dage, idet 7 dage foretrækkes, og det andet tidsrum er mellem 3 dage og 10 dage, idet 7 dage foretrækkes, og det tredje tidsrum er mellem 8 dage og 78 dage, idet 14 eller 42 dage foretrækkes.
- 14. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 8 til 13, hvor den tredje dosis overstiger den første og anden dosis.
- 15. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 8 til 14, hvor den første dosis er mellem 1 og 15 pg/m2/d, idet 5 pg/m2/d foretrækkes.
- 16. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 8 til 15, hvor den anden dosis er mellem 1 og 15 pg/m /d, idet 15 pg/m /d foretrækkes.
- 17. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 8 til 16, hvor den tredje dosis er mellem 15 og 60 pg/m /d, idet 60 pg/m2/d foretrækkes.
- 18. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 8 til 17, hvor administrations vej en for den tredje dosis er intravenøs.
- 19. CD 19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 1 til 18, hvor antistoffet er et bispecifikt enkeltkædet antistof, og antistoffet fortrinsvis er MT 103.
- 20. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 1 til 19, hvor de maligne CD19-positive lymfocytter er lymfom- eller leukæmiceller, og lymfomet fortrinsvis er indolent eller aggressivt B-celle-non-Hodgkins lymfom (B-NHL), mantle-celle-lymfom (MCL) eller kronisk lymfatisk leukæmi (CLL), og leukæmien fortrinsvis er B-celle-akut lymfoblastær leukæmi (ALL).
- 21. CD19xCD3-bispecifikt antistof til anvendelse ifølge et hvilket som helst af kravene 1 til 20, hvor den humane patient, der har et B:T-celleforhold på ca. 1:5 eller derunder, identificeres ved: (a) bestemmelse af forholdet mellem B-celler og T-celler i en prøve fra patienten; og (b) identificering af patienten som en person med en forøget risiko for potentielle bivirkninger, når forholdet er ca. 1:5 eller derunder.
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 (2)
| Publication Number | Publication Date |
|---|---|
| DK2493503T3 true DK2493503T3 (da) | 2015-11-09 |
| DK2493503T4 DK2493503T4 (da) | 2021-04-12 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10771102.0T DK2493503T4 (da) | 2009-10-27 | 2010-10-27 | Doseringsplan for administrering af et cd19xcd3-bispecifikt antistof |
Country Status (26)
| Country | Link |
|---|---|
| US (2) | US8840888B2 (da) |
| EP (1) | EP2493503B2 (da) |
| JP (2) | JP6092625B2 (da) |
| KR (2) | KR101841781B1 (da) |
| CN (2) | CN102711822A (da) |
| AU (1) | AU2010311559B2 (da) |
| BR (1) | BR112012009778A2 (da) |
| CA (1) | CA2774919C (da) |
| CY (1) | CY1116874T1 (da) |
| DK (1) | DK2493503T4 (da) |
| ES (1) | ES2552655T5 (da) |
| HR (1) | HRP20151196T4 (da) |
| HU (1) | HUE025759T2 (da) |
| IL (1) | IL219301A (da) |
| ME (1) | ME02947B (da) |
| MX (1) | MX2012004880A (da) |
| NZ (1) | NZ598732A (da) |
| PL (1) | PL2493503T5 (da) |
| PT (1) | PT2493503E (da) |
| RS (1) | RS54655B2 (da) |
| RU (1) | RU2548746C2 (da) |
| SG (2) | SG179204A1 (da) |
| SI (1) | SI2493503T2 (da) |
| SM (1) | SMT201500267B (da) |
| WO (1) | WO2011051307A1 (da) |
| ZA (1) | ZA201201774B (da) |
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| PL2918604T3 (pl) * | 2008-11-07 | 2018-05-30 | Amgen Research (Munich) Gmbh | Leczenie pediatrycznej ostrej białaczki limfoblastycznej |
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| CN103459425B (zh) * | 2010-10-27 | 2015-11-25 | 安进研发（慕尼黑）股份有限公司 | 用于治疗dlbcl的组合物 |
| EA026075B1 (ru) * | 2010-11-10 | 2017-02-28 | Эмджен Рисерч (Мьюник) Гмбх | Предотвращение неблагоприятных эффектов, вызванных cd3-специфическими связывающими доменами |
| KR102345943B1 (ko) * | 2011-04-28 | 2021-12-31 | 암젠 리서치 (뮌헨) 게엠베하 | 잠재적 유해 효과의 위험에 처한 환자에게 cd19xcd3 이중특이적 항체를 투여하기 위한 투여 요법 |
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