HRP20150400T1 - Lijeäśenje pedijatrijske akutne limfoblastiäśne leukemije - Google Patents
Lijeäśenje pedijatrijske akutne limfoblastiäśne leukemije Download PDFInfo
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- HRP20150400T1 HRP20150400T1 HRP20150400TT HRP20150400T HRP20150400T1 HR P20150400 T1 HRP20150400 T1 HR P20150400T1 HR P20150400T T HRP20150400T T HR P20150400TT HR P20150400 T HRP20150400 T HR P20150400T HR P20150400 T1 HRP20150400 T1 HR P20150400T1
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- chain antibody
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- 208000018805 childhood acute lymphoblastic leukemia Diseases 0.000 title claims 5
- 208000024893 Acute lymphoblastic leukemia Diseases 0.000 claims 12
- 208000014697 Acute lymphocytic leukaemia Diseases 0.000 claims 11
- 208000006664 Precursor Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 11
- 208000007660 Residual Neoplasm Diseases 0.000 claims 6
- 230000000735 allogeneic effect Effects 0.000 claims 3
- 238000000034 method 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
- 108091008874 T cell receptors Proteins 0.000 claims 2
- 102000016266 T-Cell Antigen Receptors Human genes 0.000 claims 2
- 125000003275 alpha amino acid group Chemical group 0.000 claims 2
- 230000008030 elimination Effects 0.000 claims 2
- 238000003379 elimination reaction Methods 0.000 claims 2
- 238000011134 hematopoietic stem cell transplantation Methods 0.000 claims 2
- 230000000116 mitigating effect Effects 0.000 claims 2
- 230000008707 rearrangement Effects 0.000 claims 2
- 238000011476 stem cell transplantation Methods 0.000 claims 2
- WEVYNIUIFUYDGI-UHFFFAOYSA-N 3-[6-[4-(trifluoromethoxy)anilino]-4-pyrimidinyl]benzamide Chemical compound NC(=O)C1=CC=CC(C=2N=CN=C(NC=3C=CC(OC(F)(F)F)=CC=3)C=2)=C1 WEVYNIUIFUYDGI-UHFFFAOYSA-N 0.000 claims 1
- 208000031404 Chromosome Aberrations Diseases 0.000 claims 1
- 108700005091 Immunoglobulin Genes Proteins 0.000 claims 1
- 208000008691 Precursor B-Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 1
- 108700019889 TEL-AML1 fusion Proteins 0.000 claims 1
- 208000037280 Trisomy Diseases 0.000 claims 1
- 210000003719 b-lymphocyte Anatomy 0.000 claims 1
- 210000000349 chromosome Anatomy 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- 230000002489 hematologic effect Effects 0.000 claims 1
- 238000001802 infusion Methods 0.000 claims 1
- 208000032839 leukemia Diseases 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 239000002243 precursor Substances 0.000 claims 1
- 238000000638 solvent extraction Methods 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
-
- 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
-
- 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
-
- 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
-
- 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)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Cell Biology (AREA)
- Hematology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Mycology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Oncology (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 (19)
1. CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt, naznačeno time što je namijenjeno upotrebi u postupku liječenja, ublažavanja ili otklanjanja pedijatrijske akutne limfoblastične leukemije (ALL) kod pedijatrijskog pacijenta s ALL.
2. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 1, naznačen time što je navedena pedijatrijska akutna limfoblastična leukemija (ALL) pedijatrijska akutna limfoblastična leukemija (ALL) B-loze, po mogućnosti pedijatrijska akutna limfoblastična leukemija ALL preteča B-stanica, poželjnije pedijatrijska pro-B ALL, pre-B ALL ili zajednička ALL (cALL).
3. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 1 ili 2, naznačen time što je navedena akutna limfoblastična leukemija (ALL) refrakterna i/ili recidiv ALL.
4. Konstrukt namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što je postupak namijenjen liječenju, ublažavanju ili otklanjanju minimalne preostale bolesti (MRD) kod pedijatrijskog pacijenta s ALL.
5. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 4, naznačen time što je navedeni pedijatrijski pacijent s ALL pozitivnom na MRD kod potpunog hematološkog povlačenja.
6. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 4 ili 5, naznačen time što se MRD mjeri kvantitativnim opažanjem najmanje jedne od citogenetičkih abnormalnosti ili pregradnji, koje se bira iz skupine koju čine:
t(12;21)[TEL-AML1];
t(1;19)[E2A-PBX];
t(4;11)[AF4-MLL];
t(9;22)[BCR-ABL];
hiperdiploidnost ili trisomije kromosoma 4, 10 i 17;
hipodiploidnost;
pregradnje imunoglobulinskih gena; i
pregradnje receptora T-stanica (TCR).
7. Konstrukt namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što su odgovarajuća varijabilna područja teškog lanca (VH) i odgovarajuća varijabilna područja lakog lanca (VL) u navedenom CD19xCD3 bispecifičnom jednolančanom protutijelu kao konstruktu posložena, od N-kraja do C-kraja, ovim redoslijedom: VL(CD19)-VH(CD19)-VH(CD3)-VL(CD3).
8. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 7, naznačen time što navedeno CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt ima aminokiselinski slijed kako što je iznijet u SEQ ID NO. 1, ili aminokiselinski slijed koji je najmanje 90%, po mogućnosti 95%, istovjetan sa SEQ ID NO. 1.
9. Konstrukt namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što farmaceutski pripravak koji sadrži CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt treba primjenjivati kontinuiranom infuzijom najmanje četiri tjedna, za čim slijedi dvotjedni interval bez liječenja.
10. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 9, naznačen time što navedenu primjenu treba ponoviti najmanje dva, tri, četiri, pet, šest, sedam, osam, devet ili deset puta, nakon što se odredi status negativnosti na MRD.
11. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 9 ili 10, naznačen time što se postupak provodi prije alogenog presađivanja matičnih stanica (HSCT) kako bi se promijenilo ALL pozitivnu na MRD u status negativnosti na MRD.
12. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 9 ili 10, naznačen time što se postupak provodi nakon alogenog presađivanja krvotvornih matičnih stanica (HSCT).
13. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 12, naznačen time što CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt potiče učinak presatka prema leukemiji (GvL).
14. Konstrukt namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačen time što CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt treba primijeniti u dnevnoj dozi od 10 µg do 100 µg/m2 tjelesne površine pacijenta.
15. Konstrukt namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačen time što CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt treba primijeniti u dnevnoj dozi od 15 µg do 30 µg/m2 tjelesne površine pacijenta.
16. Konstrukt namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačen time što CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt treba primijeniti u dnevnoj dozi od 15 µg, 30 µg, 60 µg ili 90 µg/m2 tjelesne površine pacijenta.
17. Konstrukt namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačen time što CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt prvog ili prvih dana treba primijeniti u dozi od 5 µg, sljedećeg ili sljedećih dana u dozi od 15 µg, a preostali period primjene od ukupno 4 tjedna u dozi od 30 ili 45 µg/m2 tjelesne površine pacijenta kao dnevnoj dozi.
18. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 17, naznačen time što se dvije početne doze primjenjuje 2, 3, 4, 5, 6 ili 7 dana ili čak i dulje.
19. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 1 ili 2, naznačen time što navedeni pacijent nije prikladan za alogeno presađivanje matičnih stanica.
Applications Claiming Priority (5)
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 | |
PCT/EP2009/007969 WO2010052013A1 (en) | 2008-11-07 | 2009-11-06 | Treatment of pediatric acute lymphoblastic leukemia |
EP09764710.1A EP2344539B1 (en) | 2008-11-07 | 2009-11-06 | Treatment of pediatric acute lymphoblastic leukemia |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20150400T1 true HRP20150400T1 (hr) | 2015-05-08 |
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 After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
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 |
Country Status (27)
Country | Link |
---|---|
US (2) | US20110262440A1 (hr) |
EP (4) | EP2918604B1 (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) | DK2918604T3 (hr) |
ES (3) | ES2662929T3 (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) | PL2918604T3 (hr) |
PT (3) | PT2918604T (hr) |
RS (3) | RS53980B1 (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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WO2010079339A2 (en) * | 2009-01-09 | 2010-07-15 | Oxford Biomedica (Uk) Limited | Factors |
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RU2678127C2 (ru) * | 2012-11-13 | 2019-01-23 | Бионтех Аг | Агенты для лечения экспрессирующих клаудин раковых заболеваний |
TWI682941B (zh) | 2013-02-01 | 2020-01-21 | 美商再生元醫藥公司 | 含嵌合恆定區之抗體 |
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 |
US10106623B2 (en) | 2014-02-12 | 2018-10-23 | 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 |
HUE042407T2 (hu) | 2014-05-30 | 2019-06-28 | Amgen Res Munich Gmbh | B-prekurzor akut limfoblasztos leukémiában szenvedõ betegek kockázati besorolása |
US20170252364A1 (en) | 2014-07-30 | 2017-09-07 | Mor Research Applications Ltd. | Compositions for treatment of acute lymphoblastic leukemia and methods of use thereof |
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SI3280729T1 (sl) | 2015-04-08 | 2022-09-30 | Novartis Ag | Terapije CD20, terapije CD22 in kombinacija terapij s celico, ki izraža himerni antigenski receptor CD19 (CAR) |
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SG11201805048SA (en) * | 2015-12-22 | 2018-07-30 | Regeneron Pharma | Bispecific anti-cd20/anti-cd3 antibodies to treat acute lymphoblastic leukemia |
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 |
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MA48763A (fr) * | 2017-05-05 | 2020-04-08 | Amgen Inc | Composition pharmaceutique comprenant des constructions d'anticorps bispécifiques pour un stockage et une administration améliorés |
WO2018223101A1 (en) | 2017-06-02 | 2018-12-06 | Juno Therapeutics, Inc. | Articles of manufacture and methods for treatment using adoptive cell therapy |
KR102083481B1 (ko) | 2018-03-22 | 2020-03-02 | 강원대학교산학협력단 | 아연-키토산 나노 입자를 포함한 급성 림프구성 백혈병 치료용 약학조성물 |
CA3110513A1 (en) | 2018-08-31 | 2020-03-05 | Regeneron Pharmaceuticals, Inc. | Dosing strategy that mitigates cytokine release syndrome for cd3/c20 bispecific antibodies |
CN113474458A (zh) * | 2019-01-30 | 2021-10-01 | 威斯塔解剖学和生物学研究所 | 靶向癌症抗原的dna编码的双特异性t细胞连接子以及在癌症治疗中的使用方法 |
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EP2918604B1 (en) * | 2008-11-07 | 2017-12-20 | Amgen Research (Munich) GmbH | Treatment of pediatric acute lymphoblastic leukemia |
AU2010204555B2 (en) * | 2009-01-19 | 2013-03-07 | Abbvie Inc. | Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases |
NZ616828A (en) * | 2009-01-19 | 2015-03-27 | Abbvie Inc | Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases |
US8486933B2 (en) * | 2009-05-27 | 2013-07-16 | Abbvie Inc. | Pyrimidine inhibitors of kinase activity |
NZ598461A (en) * | 2009-09-20 | 2013-12-20 | Abbvie Inc | Abt-263 crystalline forms and solvates for use in treating bcl-2 protein related diseases |
RS54655B2 (sr) * | 2009-10-27 | 2021-04-29 | Amgen Res Munich Gmbh | Dozni režim za primenu cd19xcd3 bispecifičnog antitela |
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