HRP20230297T1 - UPRAVLJANJE TOKSIČNOŠĆU ZA ANTI-TUMORSKO DJELOVANJE CAR-a - Google Patents
UPRAVLJANJE TOKSIČNOŠĆU ZA ANTI-TUMORSKO DJELOVANJE CAR-a Download PDFInfo
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- HRP20230297T1 HRP20230297T1 HRP20230297TT HRP20230297T HRP20230297T1 HR P20230297 T1 HRP20230297 T1 HR P20230297T1 HR P20230297T T HRP20230297T T HR P20230297TT HR P20230297 T HRP20230297 T HR P20230297T HR P20230297 T1 HRP20230297 T1 HR P20230297T1
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- 230000001988 toxicity Effects 0.000 title claims 3
- 231100000419 toxicity Toxicity 0.000 title claims 3
- 101150102779 Cars1 gene Proteins 0.000 title 1
- 230000000259 anti-tumor effect Effects 0.000 title 1
- 229940124790 IL-6 inhibitor Drugs 0.000 claims 17
- 108091007741 Chimeric antigen receptor T cells Proteins 0.000 claims 9
- 210000001744 T-lymphocyte Anatomy 0.000 claims 8
- 239000000427 antigen Substances 0.000 claims 5
- 102000036639 antigens Human genes 0.000 claims 5
- 108091007433 antigens Proteins 0.000 claims 5
- 206010066476 Haematological malignancy Diseases 0.000 claims 4
- 208000002250 Hematologic Neoplasms Diseases 0.000 claims 4
- 102000004889 Interleukin-6 Human genes 0.000 claims 3
- 108090001005 Interleukin-6 Proteins 0.000 claims 3
- 238000001802 infusion Methods 0.000 claims 3
- 230000011664 signaling Effects 0.000 claims 3
- 208000031261 Acute myeloid leukaemia Diseases 0.000 claims 2
- 201000003793 Myelodysplastic syndrome Diseases 0.000 claims 2
- 208000033776 Myeloid Acute Leukemia Diseases 0.000 claims 2
- 206010028980 Neoplasm Diseases 0.000 claims 2
- 230000001086 cytosolic effect Effects 0.000 claims 2
- 208000032839 leukemia Diseases 0.000 claims 2
- 238000009094 second-line therapy Methods 0.000 claims 2
- 206010000830 Acute leukaemia Diseases 0.000 claims 1
- 208000024893 Acute lymphoblastic leukemia Diseases 0.000 claims 1
- 208000014697 Acute lymphocytic leukaemia Diseases 0.000 claims 1
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims 1
- 102100024222 B-lymphocyte antigen CD19 Human genes 0.000 claims 1
- 208000032791 BCR-ABL1 positive chronic myelogenous leukemia Diseases 0.000 claims 1
- 108010019670 Chimeric Antigen Receptors Proteins 0.000 claims 1
- 208000010833 Chronic myeloid leukaemia Diseases 0.000 claims 1
- 208000031637 Erythroblastic Acute Leukemia Diseases 0.000 claims 1
- 208000036566 Erythroleukaemia Diseases 0.000 claims 1
- 208000017604 Hodgkin disease Diseases 0.000 claims 1
- 208000010747 Hodgkins lymphoma Diseases 0.000 claims 1
- 101000980825 Homo sapiens B-lymphocyte antigen CD19 Proteins 0.000 claims 1
- 101000914514 Homo sapiens T-cell-specific surface glycoprotein CD28 Proteins 0.000 claims 1
- 208000031671 Large B-Cell Diffuse Lymphoma Diseases 0.000 claims 1
- 206010024305 Leukaemia monocytic Diseases 0.000 claims 1
- 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims 1
- 206010025323 Lymphomas Diseases 0.000 claims 1
- 208000025205 Mantle-Cell Lymphoma Diseases 0.000 claims 1
- 208000034578 Multiple myelomas Diseases 0.000 claims 1
- 208000033761 Myelogenous Chronic BCR-ABL Positive Leukemia Diseases 0.000 claims 1
- 208000015914 Non-Hodgkin lymphomas Diseases 0.000 claims 1
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 1
- 208000008691 Precursor B-Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 1
- 208000006664 Precursor Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 1
- 102100027213 T-cell-specific surface glycoprotein CD28 Human genes 0.000 claims 1
- 208000033559 Waldenström macroglobulinemia Diseases 0.000 claims 1
- 208000017733 acquired polycythemia vera Diseases 0.000 claims 1
- 208000021841 acute erythroid leukemia Diseases 0.000 claims 1
- 208000014619 adult acute lymphoblastic leukemia Diseases 0.000 claims 1
- 201000011184 adult acute lymphocytic leukemia Diseases 0.000 claims 1
- 230000001684 chronic effect Effects 0.000 claims 1
- 208000024207 chronic leukemia Diseases 0.000 claims 1
- 208000032852 chronic lymphocytic leukemia Diseases 0.000 claims 1
- 206010012818 diffuse large B-cell lymphoma Diseases 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 238000009093 first-line therapy Methods 0.000 claims 1
- 201000009277 hairy cell leukemia Diseases 0.000 claims 1
- 230000003834 intracellular effect Effects 0.000 claims 1
- 201000006894 monocytic leukemia Diseases 0.000 claims 1
- 208000037244 polycythemia vera Diseases 0.000 claims 1
- 108020003175 receptors Proteins 0.000 claims 1
- 102000005962 receptors Human genes 0.000 claims 1
- 150000003431 steroids Chemical class 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
- 229960003989 tocilizumab Drugs 0.000 claims 1
Classifications
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- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/14—Blood; Artificial blood
- A61K35/17—Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes
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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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- A61K39/46—Cellular immunotherapy
- A61K39/461—Cellular immunotherapy characterised by the cell type used
- A61K39/4611—T-cells, e.g. tumor infiltrating lymphocytes [TIL], lymphokine-activated killer cells [LAK] or regulatory T cells [Treg]
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- A61K39/463—Cellular immunotherapy characterised by recombinant expression
- A61K39/4631—Chimeric Antigen Receptors [CAR]
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- A61K39/464—Cellular immunotherapy characterised by the antigen targeted or presented
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- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A61K48/0083—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the administration regime
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
- C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
- C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
- C12Q1/6886—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material for cancer
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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
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
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- A61K2239/46—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterised by the cancer treated
- A61K2239/48—Blood cells, e.g. leukemia or lymphoma
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/52—Assays involving cytokines
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- G—PHYSICS
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
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- 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
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6863—Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors
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Claims (11)
1. T-stanice transducirane za ekspresiju himernog antigenskog receptora (CAR T-stanice) za uporabu u liječenju hematološke zloćudne bolesti u ljudskog pacijenta, naznačen time što se IL-6 inhibitor također daje pacijentu kako bi se upravljalo toksičnošću koja je posljedica primjene CAR T stanica, nadalje pri čemu:
(i) CAR sadrži izvanstaničnu domenu koja ima domenu za prepoznavanje antigena koja cilja tumorski antigen, transmembransku domenu, i citoplazmatsku domenu;
(ii) CAR T stanice se primjenjuju kao prva linija terapije putem infuzije, i IL-6 inhibitor se primjenjuje kao druga linija terapije; i
(iii) inhibitor IL-6 je odabran nakon otkrivanja povećane razine IL-6 kod pacijenta nakon primjene CAR T stanica.
2. IL-6 inhibitor za uporabu u kontroli toksičnosti koja je posljedica infuzije CAR T stanica ljudskom pacijentu, naznačen time što:
(i) CAR sadrži izvanstaničnu domenu koja ima domenu za prepoznavanje antigena koja cilja tumorski antigen, transmembransku domenu, i citoplazmatsku domenu;
(ii) CAR T stanice su davane kao prva linija terapije i IL-6 inhibitor se primjenjuje kao druga linija terapije; i
(iii) inhibitor IL-6 je odabran nakon otkrivanja povećane razine IL-6 u pacijenta nakon infuzije CAR T stanica.
3. CAR T stanice za uporabu prema zahtjevu 1, ili IL-6 inhibitor za uporabu prema zahtjevu 2, pri čemu CAR cilja CD 19.
4. CAR T stanice za uporabu prema zahtjevu 1 ili 3, ili IL-6 inhibitor za uporabu prema zahtjevu 2 ili 3, pri čemu CAR sadrži jednu ili više unutarstaničnih domena odabranih između CD137 (4-1BB) signalne domene, CD28 signalne domene, CD3 zeta signalne domene, ili bilo koja njihova kombinacija, izborno pri čemu je CAR kodiran lentivirusnim vektorom i sadrži domenu za prepoznavanje antigena antitijela.
5. CAR T stanice za uporabu prema bilo kojem od zahtjeva 1, 3 ili 4, ili IL-6 inhibitor za uporabu prema bilo kojem od zahtjeva 2-4, pri čemu je IL-6 inhibitor antitijelo.
6. CAR T stanice za uporabu prema zahtjevu 5, ili inhibitor IL-6 za uporabu prema zahtjevu 5, pri čemu je inhibitor IL-6 antitijelo koje:
(i) specifično veže IL-6; ili
(ii) je humanizirano anti-IL-6 receptorsko antitijelo, npr. tocilizumab.
7. CAR T stanice za uporabu prema bilo kojem od zahtjeva 1 ili 3-6, ili IL-6 inhibitor za uporabu prema bilo kojem od zahtjeva 2-6, pri čemu se steroid također daje pacijentu.
8. CAR T stanice za uporabu prema bilo kojem od zahtjeva 1 ili 3-7, ili IL-6 inhibitor za uporabu prema bilo kojem od zahtjeva 2-7, pri čemu su CAR T stanice autologne pacijentu.
9. Inhibitor IL-6 za uporabu prema bilo kojem od zahtjeva 2-8, pri čemu su CAR T stanice davane za liječenje hematološke malignosti kod pacijenta.
10. CAR T stanice za uporabu prema bilo kojem od zahtjeva 1 ili 3-8, ili IL-6 inhibitor za uporabu prema zahtjevu 9, pri čemu je hematološka malignost odabrana iz skupine koja se sastoji od leukemije, uključujući akutnu leukemiju (kao što je akutna limfocitna leukemija, akutna mijelocitna leukemija, akutna mijeloična leukemija i mijeloblastična, promijelocitična, mijelomonocitna, monocitna i eritroleukemija), kroničnu leukemiju (kao što je kronična mijelocitna (granulocitna) leukemija, kronična mijeloična leukemija i kronična limfocitna leukemija), policitemija vera, limfom, Hodgkinovu bolest, ne-Hodgkinov limfom (indolentni i oblici visokog stupnja), multipli mijelom, Waldenstromovu makroglobulinemiju, tešku lančanu bolest, mijelodisplastični sindrom, leukemiju vlasastih stanica i mijelodisplaziju.
11. CAR T stanice za uporabu prema bilo kojem od zahtjeva 1 ili 3-8, ili IL-6 inhibitor za uporabu prema zahtjevu 9, pri čemu CAR cilja CD19 i hematološka malignost je pre-B ALL (pedijatrijska indikacija), ALL za odrasle, limfom plaštenih stanica, ili difuzni limfom velikih B stanica.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261671482P | 2012-07-13 | 2012-07-13 | |
US201361782982P | 2013-03-14 | 2013-03-14 | |
EP21215762.2A EP4019041B1 (en) | 2012-07-13 | 2013-07-12 | Toxicity management for anti-tumor activity of cars |
Publications (1)
Publication Number | Publication Date |
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HRP20230297T1 true HRP20230297T1 (hr) | 2023-05-12 |
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HRP20230297TT HRP20230297T1 (hr) | 2012-07-13 | 2013-07-12 | UPRAVLJANJE TOKSIČNOŠĆU ZA ANTI-TUMORSKO DJELOVANJE CAR-a |
Country Status (22)
Country | Link |
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US (4) | US20150202286A1 (hr) |
EP (4) | EP4019041B1 (hr) |
JP (5) | JP6382191B2 (hr) |
KR (1) | KR102204029B1 (hr) |
CN (4) | CN111481667A (hr) |
AU (2) | AU2013289967B2 (hr) |
BR (1) | BR112015000660A8 (hr) |
CA (1) | CA2878928C (hr) |
DK (3) | DK2872171T3 (hr) |
EA (1) | EA201590210A1 (hr) |
ES (3) | ES2941370T3 (hr) |
FI (1) | FI4019041T3 (hr) |
HK (1) | HK1253365A1 (hr) |
HR (1) | HRP20230297T1 (hr) |
HU (3) | HUE061555T2 (hr) |
IN (1) | IN2014DN11155A (hr) |
LT (3) | LT4019041T (hr) |
MX (2) | MX2015000438A (hr) |
PL (2) | PL4019041T3 (hr) |
PT (3) | PT3338794T (hr) |
SI (1) | SI4019041T1 (hr) |
WO (1) | WO2014011984A1 (hr) |
Families Citing this family (100)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2014011984A1 (en) | 2012-07-13 | 2014-01-16 | The Trustees Of The University Of Pennsylvania | Toxicity management for anti-tumor activity of cars |
WO2014130635A1 (en) | 2013-02-20 | 2014-08-28 | Novartis Ag | Effective targeting of primary human leukemia using anti-cd123 chimeric antigen receptor engineered t cells |
RU2708032C2 (ru) | 2013-02-20 | 2019-12-03 | Новартис Аг | ЛЕЧЕНИЕ РАКА С ИСПОЛЬЗОВАНИЕМ ХИМЕРНОГО АНТИГЕНСПЕЦИФИЧЕСКОГО РЕЦЕПТОРА НА ОСНОВЕ ГУМАНИЗИРОВАННОГО АНТИТЕЛА ПРОТИВ EGFRvIII |
EP2970426B1 (en) | 2013-03-15 | 2019-08-28 | Michael C. Milone | Targeting cytotoxic cells with chimeric receptors for adoptive immunotherapy |
UY35468A (es) | 2013-03-16 | 2014-10-31 | Novartis Ag | Tratamiento de cáncer utilizando un receptor quimérico de antígeno anti-cd19 |
CA3225453A1 (en) | 2013-12-19 | 2015-06-25 | Novartis Ag | Human mesothelin chimeric antigen receptors and uses thereof |
EP3087101B1 (en) | 2013-12-20 | 2024-06-05 | Novartis AG | Regulatable chimeric antigen receptor |
WO2015112626A1 (en) | 2014-01-21 | 2015-07-30 | June Carl H | Enhanced antigen presenting ability of car t cells by co-introduction of costimulatory molecules |
HUE054588T2 (hu) | 2014-04-07 | 2021-09-28 | Novartis Ag | Rák kezelése CD19 elleni, kiméra antigénreceptor alkalmazásával |
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