HRP20191715T1 - Liječenje dječje akutne limfoblastične leukemije sa bispecifičnim protutijelima protiv cd3xcd19 - Google Patents
Liječenje dječje akutne limfoblastične leukemije sa bispecifičnim protutijelima protiv cd3xcd19 Download PDFInfo
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- HRP20191715T1 HRP20191715T1 HRP20191715T HRP20191715T1 HR P20191715 T1 HRP20191715 T1 HR P20191715T1 HR P20191715 T HRP20191715 T HR P20191715T HR P20191715 T1 HRP20191715 T1 HR P20191715T1
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- Prior art keywords
- construct
- use according
- patient
- single chain
- chain antibody
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Links
- 208000018805 childhood acute lymphoblastic leukemia Diseases 0.000 title claims 5
- 208000024893 Acute lymphoblastic leukemia Diseases 0.000 claims 7
- 208000014697 Acute lymphocytic leukaemia Diseases 0.000 claims 6
- 208000006664 Precursor Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 6
- 208000007660 Residual Neoplasm Diseases 0.000 claims 4
- 238000002512 chemotherapy Methods 0.000 claims 3
- 238000011134 hematopoietic stem cell transplantation Methods 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
- 230000000735 allogeneic effect Effects 0.000 claims 2
- 125000003275 alpha amino acid group Chemical group 0.000 claims 2
- 201000011633 childhood acute lymphocytic leukemia Diseases 0.000 claims 2
- 210000004899 c-terminal region Anatomy 0.000 claims 1
- 230000008029 eradication Effects 0.000 claims 1
- 230000002489 hematologic effect Effects 0.000 claims 1
- 238000001802 infusion Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
Classifications
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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
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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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- 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
-
- 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
- C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
- C07K16/3061—Blood cells
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/46—Hybrid immunoglobulins
- C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Cell Biology (AREA)
- Hematology (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Oncology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Claims (14)
1. CD19xCD3 konstrukt protutijela bispecifičnog jednostrukog lanca za uporabu u postupku liječenja, poboljšanja ili uklanjanja dječje akutne limfoblastične leukemije (ALL) kod pedijatrijskog ALL pacijenta, naznačen time što navedena dječja ALL je refraktorna prema kemoterapiji ili alogenoj transplantaciji hematopoetskih matičnih stanica (HSCT).
2. Konstrukt za uporabu prema zahtjevu 1, naznačen time što je navedena dječja akutna limfoblastična leukemija (ALL) refraktorna prema kemoterapiji i alogenoj transplantaciji hematopoetskih matičnih stanica (HSCT).
3. Konstrukt za uporabu prema zahtjevu 1 ili 2, naznačen time što je navedena akutna limfoblastična leukemija (ALL) relapsirajuća ALL ili relapsirajuća ALL refraktorna prema kemoterapiji i/ili transplantaciji hematopoetskih matičnih stanica (HSCT).
4. Konstrukt za uporabu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time što postupak za liječenje, poboljšanje ili uklanjanje minimalne rezidualne bolesti (MRD) kod pedijatrijskog ALL pacijenta.
5. Konstrukt za uporabu prema zahtjevu 4, naznačen time što navedeni dječji pacijent s ALL je MRD-pozitivan u potpunoj hematološkoj remisiji.
6. Konstrukt za uporabu prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time što su odgovarajuće varijabilne regije teškog lanca (VH) i odgovarajuće varijabilne regije laganog lanca (VL) u navedenom CD19xCD3 konstruktu protutijela bispecifičnog jednostrukog lanca posložene, od N-terminalnog kraja do C-terminalnog kraja, redoslijedom, VL(CD19)-VH(CD19)-VH(CD3)-VL(CD3).
7. Konstrukt za uporabu prema zahtjevu 6, naznačen time što navedeni CD19xCD3 konstrukt protutijela bispecifičnog jednostrukog lanca sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO. 1, ili aminokiselinsku sekvencu koja je barem 90%, poželjno 95% identična sa SEQ ID NO. 1.
8. Konstrukt za uporabu prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time što se farmaceutski pripravak koji sadrži CD19xCD3 konstrukt protutijela bispecifičnog jednostrukog lanca treba davati kontinuiranom infuzijom najmanje četiri tjedna nakon čega slijedi interval od 2 tjedna bez tretmana.
9. Konstrukt za uporabu prema zahtjevu 8, naznačen time što se nakon određivanja negativnog statusa MRD-a navedeno davanje ponavlja najmanje dva, tri, četiri, pet, šest, sedam, osam, devet i deset puta.
10. Konstrukt za uporabu prema bilo kojem od patentnih zahtjeva 1 do 9, naznačen time što se CD19xCD3 konstrukt protutijela bispecifičnog jednostrukog lanca daje u dnevnoj dozi od 10 µg do 100 µg po kvadratnom metru površine tijela pacijenta.
11. Konstrukt za uporabu prema bilo kojem od patentnih zahtjeva 1 do 9, naznačen time što se CD19xCD3 konstrukt protutijela bispecifičnog jednostrukog lanca daje u dnevnoj dozi od 15 µg do 30 µg po kvadratnom metru površine tijela pacijenta.
12. Konstrukt za uporabu prema patentnim zahtjevima 1 do 9, naznačen time što se CD19xCD3 konstrukt protutijela bispecifičnog jednostrukog lanca daje u dnevnoj dozi od 15 µg, 30 µg, 60 µg ili 90 µg po kvadratnom metru površine tijela pacijenta.
13. Konstrukt za uporabu prema patentnim zahtjevima 1 do 9, naznačen time što se CD19xCD3 konstrukt protutijela bispecifičnog jednostrukog lanca daje u dozi od 5 µg po kvadratnom metru površine tijela pacijenta prvog dana, nakon čega slijedi primjena 15 µg po kvadratnom metru površine tijela pacijenta tijekom slijedećeg(ih) dana, nakon čega slijedi primjena 30 µg ili 45 µg po kvadratnom metru površine tijela pacijenta kao dnevna doza tijekom preostalog razdoblja davanja od ukupno četiri tjedna.
14. Konstrukt za uporabu prema zahtjevu 13, naznačen time što se dvije početne doze daju tijekom 1, 2, 3, 4, 5, 6, ili 7 dana ili čak i duže.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11232308P | 2008-11-07 | 2008-11-07 | |
US18329109P | 2009-06-02 | 2009-06-02 | |
US22126909P | 2009-06-29 | 2009-06-29 | |
EP17206868.6A EP3330293B1 (en) | 2008-11-07 | 2009-11-06 | Treatment of pediatric acute lymphoblastic leukemia with bispecific antibodies against cd3xcd19 |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20191715T1 true HRP20191715T1 (hr) | 2019-12-13 |
Family
ID=41796119
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20150400TT HRP20150400T1 (hr) | 2008-11-07 | 2015-04-10 | Lijeäśenje pedijatrijske akutne limfoblastiäśne leukemije |
HRP20180426TT HRP20180426T1 (hr) | 2008-11-07 | 2018-03-12 | Liječenje pedijatrijske akutne limfoblastične leukemije |
HRP20191715 HRP20191715T1 (hr) | 2008-11-07 | 2019-09-20 | Liječenje dječje akutne limfoblastične leukemije sa bispecifičnim protutijelima protiv cd3xcd19 |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20150400TT HRP20150400T1 (hr) | 2008-11-07 | 2015-04-10 | Lijeäśenje pedijatrijske akutne limfoblastiäśne leukemije |
HRP20180426TT HRP20180426T1 (hr) | 2008-11-07 | 2018-03-12 | Liječenje pedijatrijske akutne limfoblastične leukemije |
Country Status (27)
Country | Link |
---|---|
US (2) | US20110262440A1 (hr) |
EP (4) | EP3594237A1 (hr) |
JP (2) | JP5798036B2 (hr) |
KR (1) | KR101695329B1 (hr) |
CN (2) | CN106390114A (hr) |
AU (1) | AU2009313039B2 (hr) |
BR (1) | BRPI0921341A2 (hr) |
CA (1) | CA2742242C (hr) |
CY (3) | CY1116160T1 (hr) |
DK (3) | DK3330293T3 (hr) |
ES (3) | ES2748126T3 (hr) |
HK (3) | HK1158667A1 (hr) |
HR (3) | HRP20150400T1 (hr) |
HU (3) | HUE046222T2 (hr) |
IL (1) | IL212651A (hr) |
LT (2) | LT2918604T (hr) |
MX (1) | MX2011002931A (hr) |
NO (1) | NO2918604T3 (hr) |
NZ (1) | NZ591312A (hr) |
PL (3) | PL2344539T3 (hr) |
PT (3) | PT2918604T (hr) |
RS (3) | RS56989B1 (hr) |
RU (3) | RU2536933C2 (hr) |
SG (1) | SG195549A1 (hr) |
SI (3) | SI2918604T1 (hr) |
SM (1) | SMT201500104B (hr) |
WO (1) | WO2010052013A1 (hr) |
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JPS6358588A (ja) * | 1986-08-29 | 1988-03-14 | Toshiba Corp | バ−コ−ド読取装置 |
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EP3594237A1 (en) * | 2008-11-07 | 2020-01-15 | Amgen Research (Munich) GmbH | Treatment of pediatric acute lymphoblastic leukemia |
EP3517961B1 (en) * | 2009-01-09 | 2020-12-30 | Oxford BioMedica (UK) Limited | Factors |
US20150231241A1 (en) * | 2012-08-14 | 2015-08-20 | Ibc Pharmaceuticals, Inc. | Combination therapy for inducing immune response to disease |
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CN103131777A (zh) * | 2013-02-05 | 2013-06-05 | 南京艾迪康医学检验所有限公司 | 用于检测e2a-pbx融合基因相对表达量的试剂盒 |
EP3105252B1 (en) | 2014-02-12 | 2019-07-24 | Michael Uhlin | Bispecific antibodies for use in stem cell transplantation |
TWI701042B (zh) | 2014-03-19 | 2020-08-11 | 美商再生元醫藥公司 | 用於腫瘤治療之方法及抗體組成物 |
EP3531133B1 (en) | 2014-05-30 | 2023-08-23 | Amgen Research (Munich) GmbH | Risk-stratification of b-precursor acute lymphoblastic leukemia patients |
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PL3221359T3 (pl) | 2014-11-17 | 2020-11-16 | Regeneron Pharmaceuticals, Inc. | Sposoby leczenia nowotworów przy użyciu dwuswoistego przeciwciała CD3XCD20 |
CN107635578A (zh) * | 2015-02-05 | 2018-01-26 | Stc.Unm 公司 | 抗前‑bcr拮抗剂和方法 |
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SG11201708191XA (en) | 2015-04-08 | 2017-11-29 | Novartis Ag | Cd20 therapies, cd22 therapies, and combination therapies with a cd19 chimeric antigen receptor (car) - expressing cell |
AU2016263464B2 (en) * | 2015-05-20 | 2021-12-23 | Amgen Research (Munich) Gmbh | B-cell depletion as a diagnostic marker |
BR112018012929A2 (pt) * | 2015-12-22 | 2018-12-11 | Regeneron Pharma | anticorpos anti-cd20/anti-cd3 biespecíficos para tratar leucemia linfoblástica aguda |
GB201602974D0 (en) * | 2016-02-19 | 2016-04-06 | Clube Jasper R | Engineered cells & methods (1) |
MA45341A (fr) * | 2016-06-06 | 2019-04-10 | Hutchinson Fred Cancer Res | Procédés de traitement de malignités de lymphocytes b au moyen d'une thérapie cellulaire adoptive |
US11590167B2 (en) | 2016-12-03 | 2023-02-28 | Juno Therapeutic, Inc. | Methods and compositions for use of therapeutic T cells in combination with kinase inhibitors |
KR20190141243A (ko) * | 2017-05-05 | 2019-12-23 | 암젠 인크 | 개선된 저장 및 투여를 위한 이중특이적 항체 구축물을 포함하는 약제학적 조성물 |
JP2020522489A (ja) | 2017-06-02 | 2020-07-30 | ジュノー セラピューティクス インコーポレイテッド | 養子細胞療法を用いる処置のための製造物品および方法 |
KR102083481B1 (ko) | 2018-03-22 | 2020-03-02 | 강원대학교산학협력단 | 아연-키토산 나노 입자를 포함한 급성 림프구성 백혈병 치료용 약학조성물 |
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AU2020214336A1 (en) * | 2019-01-30 | 2021-09-09 | The Wistar Institute Of Anatomy And Biology | DNA-encoded bispecific T-cell engagers targeting cancer antigens and methods of use in cancer theraputics |
KR102503349B1 (ko) | 2019-05-14 | 2023-02-23 | 프로벤션 바이오, 인코포레이티드 | 제1형 당뇨병을 예방하기 위한 방법 및 조성물 |
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JP2008501621A (ja) * | 2003-05-31 | 2008-01-24 | マイクロメット アクツィエン ゲゼルシャフト | B細胞関連疾患を処置するための二重特異性抗cd3、抗cd19抗体構築物を含む薬学的組成物 |
DK1673398T3 (da) * | 2003-10-16 | 2011-04-18 | Micromet Ag | Multispecifikke, deimmuniserede CD3-bindere |
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EP2352763B2 (en) * | 2008-10-01 | 2022-09-21 | Amgen Research (Munich) GmbH | Bispecific single chain antibodies with specificity for high molecular weight target antigens |
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RU2538965C2 (ru) * | 2009-01-19 | 2015-01-10 | Эббви Инк. | Вызывающие апоптоз средства для лечения рака и иммунных и аутоиммунных заболеваний |
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JP6092625B2 (ja) * | 2009-10-27 | 2017-03-08 | アムゲン リサーチ (ミュンヘン) ゲーエムベーハー | CD19xCD3二重特異性抗体を投与するための投与計画 |
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2009
- 2009-11-06 EP EP19187179.7A patent/EP3594237A1/en active Pending
- 2009-11-06 CA CA2742242A patent/CA2742242C/en active Active
- 2009-11-06 KR KR1020117010642A patent/KR101695329B1/ko active IP Right Grant
- 2009-11-06 MX MX2011002931A patent/MX2011002931A/es active IP Right Grant
- 2009-11-06 PL PL09764710T patent/PL2344539T3/pl unknown
- 2009-11-06 BR BRPI0921341A patent/BRPI0921341A2/pt not_active Application Discontinuation
- 2009-11-06 JP JP2011533632A patent/JP5798036B2/ja active Active
- 2009-11-06 DK DK17206868.6T patent/DK3330293T3/da active
- 2009-11-06 EP EP09764710.1A patent/EP2344539B1/en active Active
- 2009-11-06 WO PCT/EP2009/007969 patent/WO2010052013A1/en active Application Filing
- 2009-11-06 CN CN201610281293.4A patent/CN106390114A/zh active Pending
- 2009-11-06 LT LTEP15154416.0T patent/LT2918604T/lt unknown
- 2009-11-06 SG SG2013076310A patent/SG195549A1/en unknown
- 2009-11-06 SI SI200931817T patent/SI2918604T1/en unknown
- 2009-11-06 ES ES17206868T patent/ES2748126T3/es active Active
- 2009-11-06 RS RS20180309A patent/RS56989B1/sr unknown
- 2009-11-06 PL PL17206868T patent/PL3330293T3/pl unknown
- 2009-11-06 CN CN200980144400.7A patent/CN102209729B/zh active Active
- 2009-11-06 US US13/127,538 patent/US20110262440A1/en not_active Abandoned
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