NZ727479B2 - Expansion of lymphocytes with a cytokine composition for active cellular immunotherapy - Google Patents
Expansion of lymphocytes with a cytokine composition for active cellular immunotherapy Download PDFInfo
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- NZ727479B2 NZ727479B2 NZ727479A NZ72747915A NZ727479B2 NZ 727479 B2 NZ727479 B2 NZ 727479B2 NZ 727479 A NZ727479 A NZ 727479A NZ 72747915 A NZ72747915 A NZ 72747915A NZ 727479 B2 NZ727479 B2 NZ 727479B2
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- 210000004698 lymphocyte Anatomy 0.000 title claims abstract 13
- 238000009169 immunotherapy Methods 0.000 title abstract 2
- 102000004127 Cytokines Human genes 0.000 title 1
- 108090000695 Cytokines Proteins 0.000 title 1
- 230000001413 cellular effect Effects 0.000 title 1
- 238000000034 method Methods 0.000 claims abstract 12
- 241000124008 Mammalia Species 0.000 claims abstract 10
- 210000004027 cell Anatomy 0.000 claims abstract 9
- 238000012258 culturing Methods 0.000 claims abstract 8
- 102000003812 Interleukin-15 Human genes 0.000 claims abstract 7
- 108090000172 Interleukin-15 Proteins 0.000 claims abstract 7
- 102100030704 Interleukin-21 Human genes 0.000 claims abstract 7
- 108010074108 interleukin-21 Proteins 0.000 claims abstract 7
- 108010002350 Interleukin-2 Proteins 0.000 claims abstract 6
- 102000000588 Interleukin-2 Human genes 0.000 claims abstract 6
- 238000000338 in vitro Methods 0.000 claims abstract 4
- 239000007788 liquid Substances 0.000 claims abstract 2
- 239000000427 antigen Substances 0.000 claims 5
- 108091007433 antigens Proteins 0.000 claims 5
- 102000036639 antigens Human genes 0.000 claims 5
- 238000011534 incubation Methods 0.000 claims 4
- 210000003171 tumor-infiltrating lymphocyte Anatomy 0.000 claims 4
- 206010028980 Neoplasm Diseases 0.000 claims 3
- 239000001963 growth medium Substances 0.000 claims 3
- 208000023275 Autoimmune disease Diseases 0.000 claims 2
- 150000001413 amino acids Chemical class 0.000 claims 2
- 238000011156 evaluation Methods 0.000 claims 2
- 210000004881 tumor cell Anatomy 0.000 claims 2
- 208000035473 Communicable disease Diseases 0.000 claims 1
- 208000002151 Pleural effusion Diseases 0.000 claims 1
- 108700019146 Transgenes Proteins 0.000 claims 1
- 210000000683 abdominal cavity Anatomy 0.000 claims 1
- 230000000735 allogeneic effect Effects 0.000 claims 1
- 125000003275 alpha amino acid group Chemical group 0.000 claims 1
- 210000001185 bone marrow Anatomy 0.000 claims 1
- 230000004663 cell proliferation Effects 0.000 claims 1
- 210000000038 chest Anatomy 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
- 230000016396 cytokine production Effects 0.000 claims 1
- 230000003013 cytotoxicity Effects 0.000 claims 1
- 231100000135 cytotoxicity Toxicity 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 210000004700 fetal blood Anatomy 0.000 claims 1
- 239000012634 fragment Substances 0.000 claims 1
- 210000004475 gamma-delta t lymphocyte Anatomy 0.000 claims 1
- 208000015181 infectious disease Diseases 0.000 claims 1
- 230000003834 intracellular effect Effects 0.000 claims 1
- 210000004185 liver Anatomy 0.000 claims 1
- 210000001165 lymph node Anatomy 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000002609 medium Substances 0.000 claims 1
- 210000005259 peripheral blood Anatomy 0.000 claims 1
- 239000011886 peripheral blood Substances 0.000 claims 1
- 210000004303 peritoneum Anatomy 0.000 claims 1
- 230000026731 phosphorylation Effects 0.000 claims 1
- 238000006366 phosphorylation reaction Methods 0.000 claims 1
- 108090000765 processed proteins & peptides Proteins 0.000 claims 1
- 210000000574 retroperitoneal space Anatomy 0.000 claims 1
- 230000011664 signaling Effects 0.000 claims 1
- 210000001179 synovial fluid Anatomy 0.000 claims 1
- 210000001541 thymus gland Anatomy 0.000 claims 1
- 210000001519 tissue Anatomy 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
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K2035/124—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells the cells being hematopoietic, bone marrow derived or blood cells
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K39/46
- A61K2239/46—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterised by the cancer treated
- A61K2239/47—Brain; Nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K39/46
- A61K2239/46—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterised by the cancer treated
- A61K2239/54—Pancreas
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/26—Lymph; Lymph nodes; Thymus; Spleen; Splenocytes; Thymocytes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
-
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- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/20—Interleukins [IL]
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- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/21—Interferons [IFN]
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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
- A61K39/4632—T-cell receptors [TCR]; antibody T-cell receptor constructs
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- A61K39/46—Cellular immunotherapy
- A61K39/464—Cellular immunotherapy characterised by the antigen targeted or presented
- A61K39/4643—Vertebrate antigens
- A61K39/4644—Cancer antigens
- A61K39/464402—Receptors, cell surface antigens or cell surface determinants
- A61K39/464403—Receptors for growth factors
- A61K39/464404—Epidermal growth factor receptors [EGFR]
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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/46—Cellular immunotherapy
- A61K39/464—Cellular immunotherapy characterised by the antigen targeted or presented
- A61K39/4643—Vertebrate antigens
- A61K39/4644—Cancer antigens
- A61K39/464448—Regulators of development
- A61K39/46445—Apoptosis related proteins, e.g. survivin or livin
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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/46—Cellular immunotherapy
- A61K39/464—Cellular immunotherapy characterised by the antigen targeted or presented
- A61K39/4643—Vertebrate antigens
- A61K39/4644—Cancer antigens
- A61K39/464466—Adhesion molecules, e.g. NRCAM, EpCAM or cadherins
- A61K39/464468—Mesothelin [MSLN]
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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
- A61K39/46—Cellular immunotherapy
- A61K39/464—Cellular immunotherapy characterised by the antigen targeted or presented
- A61K39/4643—Vertebrate antigens
- A61K39/4644—Cancer antigens
- A61K39/464484—Cancer testis antigens, e.g. SSX, BAGE, GAGE or SAGE
- A61K39/464488—NY-ESO
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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
- A61K39/46—Cellular immunotherapy
- A61K39/464—Cellular immunotherapy characterised by the antigen targeted or presented
- A61K39/464838—Viral antigens
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- 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
- A61P37/00—Drugs for immunological or allergic disorders
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2501/00—Active agents used in cell culture processes, e.g. differentation
- C12N2501/20—Cytokines; Chemokines
- C12N2501/23—Interleukins [IL]
- C12N2501/2302—Interleukin-2 (IL-2)
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2501/00—Active agents used in cell culture processes, e.g. differentation
- C12N2501/20—Cytokines; Chemokines
- C12N2501/23—Interleukins [IL]
- C12N2501/2315—Interleukin-15 (IL-15)
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2501/00—Active agents used in cell culture processes, e.g. differentation
- C12N2501/20—Cytokines; Chemokines
- C12N2501/23—Interleukins [IL]
- C12N2501/2321—Interleukin-21 (IL-21)
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2501/00—Active agents used in cell culture processes, e.g. differentation
- C12N2501/50—Cell markers; Cell surface determinants
- C12N2501/515—CD3, T-cell receptor complex
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
- C12N5/06—Animal cells or tissues; Human cells or tissues
- C12N5/0602—Vertebrate cells
- C12N5/0634—Cells from the blood or the immune system
- C12N5/0636—T lymphocytes
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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
- G01N2333/54—Interleukins [IL]
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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
- G01N2333/54—Interleukins [IL]
- G01N2333/55—IL-2
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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
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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
Abstract
The present invention relates to a composition for expanding lymphocytes comprising interleukin 2 (IL-2), interleukin 15 (IL-15) and interleukin 21 (IL-21). It further relates to a method of preparing a population of clinically relevant lymphocytes, comprising the steps of: providing a previously obtained body sample from a mammal in particular a tissue sample or body liquid sample, comprising at least one lymphocyte and optionally separating the cells in the body sample, culturing the body sample in-vitro to expand and/or stimulate lymphocytes in the sample wherein the culturing comprises using IL-2, IL-15 and IL-21, and optionally determining the presence of clinically relevant lymphocyte in the cultured sample. The present invention also relates to an immunotherapy and the population of clinically relevant lymphocytes.
Claims (11)
1. A method of ing a tion of tumor infiltrating lymphocytes, comprising the steps of: - providing a body sample previously obtained from a mammal in particular a tissue sample or body liquid sample, comprising at least one lymphocyte and optionally separating the cells in the body sample; - culturing the body sample ro to expand and/or stimulate lymphocytes in the sample n the culturing comprises using IL- 2, IL-15 and IL-21, wherein the concentration of IL-2 is in the range from 500 to 2000 IU/ml, the concentration of IL-15 is in the range from 0.1 to 100 ng/ml and the concentration of IL-21 is in the range from 0.1 to 100 ng/ml; - and optionally determining the presence of a tumor infiltrating lymphocyte in the cultured ; wherein the in-vitro culturing comprises a first expansion step comprising an incubation in culture medium comprising IL-2, IL-15 and IL-21 until lymphocytes become detectable, and wherein the in-vitro culturing comprises a second expansion step comprising an incubation in culture medium sing feeder cells and/or an dy against CD3 in addition to IL-2, IL-15 and IL-21.
2. The method according to claim 1, wherein the body sample is selected from the group consisting of eral blood, cord blood, bone marrow, lymph nodes, liver, pleural effusion, thorax, abdominal cavity, synovial fluid, peritoneum, retroperitoneal space, thymus, and tumor.
3. The method according to claim 1, wherein the body sample is peripheral blood.
4. The method according to any one of claims 1 to 3, wherein the mammal, in particular a human, is selected from a mammal with a tumor disease, a mammal at risk of developing a tumor disease, a mammal with an infectious disease, a mammal at risk of ping an ious disease, a mammal with an autoimmune disease, a mammal at risk of developing an autoimmune disease.
5. The method according to any one of claims 1 to 4, wherein the time of incubation of the first expansion step is in the range from 6 hours to 180 days, preferably in the range from 4 to 10, more preferably in the range from 6 to 8 days, most preferably about 7 days.
6. The method according to any one of claims 1 to 5, wherein the e medium of the first and/or second expansion step comprises least one expansion antigen, wherein preferably the expansion antigen is a fragment of TAA, in particular a peptide comprising at least eight continuous amino acids of an amino acid ce that is at least 80 % identical to the amino acid sequences SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, or SEQ ID NO: 14.
7. The method according to any one of claims 1 to 6, wherein the in-vitro culturing further comprises a sing step, comprising an incubation in culture medium comprising refocusing cells, wherein preferably the ratio of refocusing cells to lymphocytes is in the range from 1:1 to 1:100, preferably in the range from 1:5 to 1:10.
8. The method according to any one of claims 1 to 7, wherein the culturing ses the addition of a promoter compound to promote the expansion of a specific subgroup of lymphocytes, in particular gamma-delta T-cells (??-T-cells).
9. The method according to any one of claims 1 to 8, wherein the testing for the presence of tumor infiltrating lymphocytes comprises using evaluation antigens, wherein preferably the evaluation antigens are presented to the cultured sample in a form selected from cells, in particular tumor cells, derived from the same mammal as the cultured sample (autologous cells), at least partially genetically matched allogeneic cells, in particular tumor cells, or cells sing the clinically relevant antigens as a transgene.
10. The method according to any one of claims 1 to 9, wherein the testing for the presence of tumor infiltrating lymphocytes comprises ting the lymphocytes with at least one clinically relevant n and determining a change in either one of cytokine production, in particular INF? production, cell proliferation, cytotoxicity, signaling and/or intracellular phosphorylation.
11. A method according to claim 1, ntially as herein described with reference to any one or more of the examples or figures. Original
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102014211167 | 2014-06-11 | ||
PCT/EP2015/063108 WO2015189357A1 (en) | 2014-06-11 | 2015-06-11 | Expansion of lymphocytes with a cytokine composition for active cellular immunotherapy |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ727479A NZ727479A (en) | 2023-11-24 |
NZ727479B2 true NZ727479B2 (en) | 2024-02-27 |
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