HRP20151196T4 - Režim doziranja kod primjene dvojno specifičnog protutijela cd19xcd3 - Google Patents
Režim doziranja kod primjene dvojno specifičnog protutijela cd19xcd3 Download PDFInfo
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- HRP20151196T4 HRP20151196T4 HRP20151196TT HRP20151196T HRP20151196T4 HR P20151196 T4 HRP20151196 T4 HR P20151196T4 HR P20151196T T HRP20151196T T HR P20151196TT HR P20151196 T HRP20151196 T HR P20151196T HR P20151196 T4 HRP20151196 T4 HR P20151196T4
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- Prior art keywords
- dose
- antibody
- bispecific
- per day
- time period
- Prior art date
Links
- 238000000034 method Methods 0.000 claims 5
- 210000001744 T-lymphocyte Anatomy 0.000 claims 3
- 210000003719 b-lymphocyte Anatomy 0.000 claims 3
- 102100024222 B-lymphocyte antigen CD19 Human genes 0.000 claims 2
- 101000980825 Homo sapiens B-lymphocyte antigen CD19 Proteins 0.000 claims 2
- 206010025323 Lymphomas Diseases 0.000 claims 2
- 208000025205 Mantle-Cell Lymphoma Diseases 0.000 claims 2
- 238000001990 intravenous administration Methods 0.000 claims 2
- 208000032839 leukemia Diseases 0.000 claims 2
- 210000004698 lymphocyte Anatomy 0.000 claims 2
- 230000003211 malignant effect Effects 0.000 claims 2
- 208000024893 Acute lymphoblastic leukemia Diseases 0.000 claims 1
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims 1
- 208000028564 B-cell non-Hodgkin lymphoma Diseases 0.000 claims 1
- 208000015914 Non-Hodgkin lymphomas Diseases 0.000 claims 1
- 230000002411 adverse Effects 0.000 claims 1
- 210000004027 cell Anatomy 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 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
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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
-
- 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
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- 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)
- Analytical Chemistry (AREA)
- Physics & Mathematics (AREA)
- Food Science & Technology (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Tropical Medicine & Parasitology (AREA)
- Biotechnology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Toxicology (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Ecology (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Oncology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
Claims (15)
1. Dvojno specifično protutijelo CD19xCD3 namijenjeno upotrebi u postupku liječenja zloćudnih CD19+ limfocita kod ljudskog pacijenta, gdje navedeni pacijent ima omjer između B-stanica i T-stanica od otprilike 1:5 ili manji, naznačeno time što se navedeni postupak sastoji u:
(a) primjeni prve doze dvojno specifičnog protutijela CD19xCD3 za vrijeme prvog vremenskog perioda, gdje je navedeni prvi vremenski period 7 dana; a zatim uzastopno s tim
(b) primjeni druge doze navedenog protutijela za vrijeme drugog vremenskog perioda;
gdje je navedena druga doza veća od navedene prve doze, te gdje je navedeni drugi vremenski period dulji od navedenog prvog vremenskog perioda.
2. Dvojno specifično protutijelo CD19xCD3 namijenjeno upotrebi u skladu s patentnim zahtjevom 1, naznačeno time što je način primjene u koraku (a) i/ili način primjene u koraku (b) intravenski.
3. Dvojno specifično protutijelo CDx19xCD3 namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 2, naznačeno time što je navedeni drugi vremenski period dulji od 18 dana, gdje je po mogućnosti navedeni drugi vremenski period između 18 dana i 81 dana, poželjnije 21 ili 49 dana.
4. Dvojno specifično protutijelo CD19xCD3 namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačeno time što je navedena prva doza između 1 i 15 µg/m2 dnevno, po mogućnosti 5 ili 15 µg/m2 dnevno.
5. Dvojno specifično protutijelo CD19xCD3 namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačeno time što je navedena druga doza između 15 i 60 µg/m2 dnevno, po mogućnosti 60 µg/m2 dnevno.
6. Dvojno specifično protutijelo CD19xCD3 namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 ili 2, naznačeno time što uključuje dodatnu primjenu, nakon prve i druge doze za vrijeme prvog i drugog vremenskog perioda, treće doze navedenog protutijela za vrijeme trećeg vremenskog perioda.
7. Dvojno specifično protutijelo CD19xCD3 namijenjeno upotrebi u skladu s patentnim zahtjevom 6, naznačeno time što je navedeni treći vremenski period dulji od navedenog prvog i drugog vremenskog perioda, gdje je navedena druga doza veća od navedene prve doze.
8. Dvojno specifično protutijelo CD19xCD3 namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 6 ili 7, naznačeno time što je navedena treća doza veća od navedene prve i druge doze.
9. Dvojno specifično protutijelo CD19xCD3 namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 6 do 8, naznačeno time što je navedena prva doza između 1 i 15 µg/m2 dnevno, po mogućnosti 5 µg/m2 dnevno.
10. Dvojno specifično protutijelo CD19xCD3 namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 6 do 9, naznačeno time što je navedena druga doza između 1 i 15 µg/m2 dnevno, po mogućnosti 15 µg/m2 dnevno.
11. Dvojno specifično protutijelo CD19xCD3 namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 6 do 10, naznačeno time što je navedena treća doza između 15 i 60 µg/m2 dnevno, po mogućnosti 60 µg/m2 dnevno.
12. Dvojno specifično protutijelo CD19xCD3 namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 6 do 11, naznačeno time što je način primjene treće doze intravenski.
13. Dvojno specifično protutijelo CD19xCD3 namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 12, naznačeno time što je navedeno protutijelo dvojno specifično jednolančano protutijelo, gdje je po mogućnosti navedeno protutijelo MT103.
14. Dvojno specifično protutijelo CD19xCD3 namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačeno time što su navedeni zloćudni CD19+ limfociti stanice limfoma ili leukemije, gdje je limfom po mogućnosti indolentan ili agresivan nehodgkinovski limfom B-stanica (B NHL), limfom stanica plašta (MCL) ili kronična limfatična leukemija (CLL), gdje je leukemija po mogućnosti akutna limfoblastična leukemija B-linije (ALL).
15. Dvojno specifično protutijelo CD19xCD3 namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 14, naznačeno time što se ljudski pacijent s omjerom između B-stanica i T-stanica od otprilike 1:5 ili manjim identificira:
(a) određivanjem omjera između B-stanica i T-stanica u uzorku iz navedenog pacijenta; i
(b) identificiranjem da je pacijent pod povećanim rizikom od mogućih štetnih učinaka kada je omjer otprilike 1:5 ili manji.
Applications Claiming Priority (4)
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 |
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 |
---|---|
HRP20151196T1 HRP20151196T1 (hr) | 2015-12-18 |
HRP20151196T4 true HRP20151196T4 (hr) | 2021-04-02 |
Family
ID=43921378
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20151196TT HRP20151196T4 (hr) | 2009-10-27 | 2015-11-09 | Režim doziranja kod primjene dvojno specifičnog protutijela cd19xcd3 |
Country Status (27)
Country | Link |
---|---|
US (2) | US8840888B2 (hr) |
EP (1) | EP2493503B2 (hr) |
JP (2) | JP6092625B2 (hr) |
KR (2) | KR102406407B1 (hr) |
CN (2) | CN107227335A (hr) |
AU (1) | AU2010311559B2 (hr) |
BR (1) | BR112012009778A2 (hr) |
CA (1) | CA2774919C (hr) |
CY (1) | CY1116874T1 (hr) |
DK (1) | DK2493503T4 (hr) |
ES (1) | ES2552655T5 (hr) |
HK (1) | HK1172828A1 (hr) |
HR (1) | HRP20151196T4 (hr) |
HU (1) | HUE025759T2 (hr) |
IL (1) | IL219301A (hr) |
ME (1) | ME02947B (hr) |
MX (1) | MX2012004880A (hr) |
NZ (1) | NZ598732A (hr) |
PL (1) | PL2493503T5 (hr) |
PT (1) | PT2493503E (hr) |
RS (1) | RS54655B2 (hr) |
RU (1) | RU2548746C2 (hr) |
SG (2) | SG179204A1 (hr) |
SI (1) | SI2493503T2 (hr) |
SM (1) | SMT201500267B (hr) |
WO (1) | WO2011051307A1 (hr) |
ZA (1) | ZA201201774B (hr) |
Families Citing this family (53)
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RU2536940C2 (ru) * | 2008-11-07 | 2014-12-27 | Эмджен Рисерч(Мьюник) ГмбХ | Новое лечение острого лимфобластного лейкоза |
DK2344539T3 (en) * | 2008-11-07 | 2015-05-04 | Amgen Res Munich Gmbh | Treatment of pediatric acute lymphoblastic leukemia |
RU2548746C2 (ru) * | 2009-10-27 | 2015-04-20 | Эмджен Рисерч (Мьюник), ГмбХ | Режим дозирования для введения биспецифичного антитела cd19×cd3 |
EP3412687B1 (en) | 2010-10-27 | 2020-03-18 | Amgen Research (Munich) GmbH | Methods for treating dlbcl |
LT2637670T (lt) * | 2010-11-10 | 2017-05-25 | Amgen Research (Munich) Gmbh | Nepageidaujamų poveikių, kuriuos sukelia prisijungimo domenai specifiški cd3, prevencija |
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 |
US10968276B2 (en) | 2013-03-12 | 2021-04-06 | Xencor, Inc. | Optimized anti-CD3 variable regions |
KR102391731B1 (ko) * | 2013-01-14 | 2022-04-27 | 젠코어 인코포레이티드 | 신규한 이형이량체 단백질 |
US11053316B2 (en) | 2013-01-14 | 2021-07-06 | Xencor, Inc. | Optimized antibody variable regions |
US9605084B2 (en) | 2013-03-15 | 2017-03-28 | Xencor, Inc. | Heterodimeric proteins |
JO3529B1 (ar) * | 2013-02-08 | 2020-07-05 | Amgen Res Munich Gmbh | مضاد التصاق خلايا الدم البيض من أجل التخفيف من الاثار السلبية الممكنة الناتجة عن مجالات ارتباط cd3- المحدد |
US9486475B2 (en) | 2013-02-08 | 2016-11-08 | Amgen Research (Munich) Gmbh | PPS for the prevention of potential adverse effects caused by CD3 specific binding domains |
US10858417B2 (en) | 2013-03-15 | 2020-12-08 | Xencor, Inc. | Heterodimeric proteins |
CN103275225A (zh) * | 2013-05-10 | 2013-09-04 | 洪建� | 高亲合力抗cd31/cd146双特异单克隆抗体及其应用 |
CN104342453A (zh) * | 2013-08-06 | 2015-02-11 | 深圳先进技术研究院 | 含基因工程抗体基因表达盒的微环dna重组母质粒、含该表达盒的微环dna及应用 |
KR20230022270A (ko) | 2014-03-28 | 2023-02-14 | 젠코어 인코포레이티드 | Cd38 및 cd3에 결합하는 이중특이적 항체 |
RU2568910C2 (ru) * | 2014-04-18 | 2015-11-20 | Общество с ограниченной ответственностью "Международный биотехнологический центр "Генериум" ("МБЦ "Генериум") | Фармацевтические композиции на основе флексибоди против cd3*cd19 для лечения в-клеточных заболеваний |
HUE042407T2 (hu) | 2014-05-30 | 2019-06-28 | Amgen Res Munich Gmbh | B-prekurzor akut limfoblasztos leukémiában szenvedõ betegek kockázati besorolása |
US10259887B2 (en) | 2014-11-26 | 2019-04-16 | Xencor, Inc. | Heterodimeric antibodies that bind CD3 and tumor antigens |
AU2015353409B2 (en) | 2014-11-26 | 2019-05-09 | Xencor, Inc. | Heterodimeric antibodies that bind CD3 and tumor antigens |
TN2017000222A1 (en) | 2014-11-26 | 2018-10-19 | Xencor Inc | Heterodimeric antibodies that bind cd3 and cd38 |
WO2017008169A1 (en) | 2015-07-15 | 2017-01-19 | Zymeworks Inc. | Drug-conjugated bi-specific antigen-binding constructs |
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MA44909A (fr) | 2015-09-15 | 2018-07-25 | Acerta Pharma Bv | Association thérapeutique d'un inhibiteur du cd19 et d'un inhibiteur de la btk |
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