RU2013147157A - Способ и композиции для клеточной иммунотерапии - Google Patents
Способ и композиции для клеточной иммунотерапии Download PDFInfo
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- RU2013147157A RU2013147157A RU2013147157/10A RU2013147157A RU2013147157A RU 2013147157 A RU2013147157 A RU 2013147157A RU 2013147157/10 A RU2013147157/10 A RU 2013147157/10A RU 2013147157 A RU2013147157 A RU 2013147157A RU 2013147157 A RU2013147157 A RU 2013147157A
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- antigen
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- 238000009169 immunotherapy Methods 0.000 title claims abstract 23
- 239000000203 mixture Substances 0.000 title claims abstract 23
- 238000000034 method Methods 0.000 title claims 8
- 230000001413 cellular effect Effects 0.000 title claims 2
- 210000004027 cell Anatomy 0.000 claims abstract 41
- 239000000427 antigen Substances 0.000 claims abstract 37
- 102000036639 antigens Human genes 0.000 claims abstract 37
- 108091007433 antigens Proteins 0.000 claims abstract 37
- 230000003044 adaptive effect Effects 0.000 claims abstract 15
- 108010019670 Chimeric Antigen Receptors Proteins 0.000 claims abstract 10
- 101001018097 Homo sapiens L-selectin Proteins 0.000 claims abstract 10
- 102100033467 L-selectin Human genes 0.000 claims abstract 10
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims abstract 10
- 210000002443 helper t lymphocyte Anatomy 0.000 claims abstract 9
- 101710160107 Outer membrane protein A Proteins 0.000 claims abstract 8
- 201000010099 disease Diseases 0.000 claims abstract 7
- 206010028980 Neoplasm Diseases 0.000 claims abstract 6
- 210000001151 cytotoxic T lymphocyte Anatomy 0.000 claims abstract 6
- 244000052769 pathogen Species 0.000 claims abstract 5
- 230000001717 pathogenic effect Effects 0.000 claims abstract 5
- 102100038080 B-cell receptor CD22 Human genes 0.000 claims abstract 3
- 102100024222 B-lymphocyte antigen CD19 Human genes 0.000 claims abstract 3
- 102100022005 B-lymphocyte antigen CD20 Human genes 0.000 claims abstract 3
- 101150029707 ERBB2 gene Proteins 0.000 claims abstract 3
- 101000884305 Homo sapiens B-cell receptor CD22 Proteins 0.000 claims abstract 3
- 101000980825 Homo sapiens B-lymphocyte antigen CD19 Proteins 0.000 claims abstract 3
- 101000897405 Homo sapiens B-lymphocyte antigen CD20 Proteins 0.000 claims abstract 3
- 101000914324 Homo sapiens Carcinoembryonic antigen-related cell adhesion molecule 5 Proteins 0.000 claims abstract 3
- 101000914321 Homo sapiens Carcinoembryonic antigen-related cell adhesion molecule 7 Proteins 0.000 claims abstract 3
- 101001103039 Homo sapiens Inactive tyrosine-protein kinase transmembrane receptor ROR1 Proteins 0.000 claims abstract 3
- 101001103036 Homo sapiens Nuclear receptor ROR-alpha Proteins 0.000 claims abstract 3
- 101000617725 Homo sapiens Pregnancy-specific beta-1-glycoprotein 2 Proteins 0.000 claims abstract 3
- 102100039615 Inactive tyrosine-protein kinase transmembrane receptor ROR1 Human genes 0.000 claims abstract 3
- 102000003735 Mesothelin Human genes 0.000 claims abstract 3
- 108090000015 Mesothelin Proteins 0.000 claims abstract 3
- 102100022019 Pregnancy-specific beta-1-glycoprotein 2 Human genes 0.000 claims abstract 3
- 102000004278 Receptor Protein-Tyrosine Kinases Human genes 0.000 claims abstract 3
- 108090000873 Receptor Protein-Tyrosine Kinases Proteins 0.000 claims abstract 3
- 101001051488 Takifugu rubripes Neural cell adhesion molecule L1 Proteins 0.000 claims abstract 3
- 108700010039 chimeric receptor Proteins 0.000 claims abstract 3
- 208000035475 disorder Diseases 0.000 claims abstract 3
- 208000002672 hepatitis B Diseases 0.000 claims abstract 3
- 230000001404 mediated effect Effects 0.000 claims abstract 3
- -1 tEGFR Proteins 0.000 claims abstract 3
- 230000024932 T cell mediated immunity Effects 0.000 claims abstract 2
- 208000036142 Viral infection Diseases 0.000 claims abstract 2
- 230000002489 hematologic effect Effects 0.000 claims abstract 2
- 230000003211 malignant effect Effects 0.000 claims abstract 2
- 201000001441 melanoma Diseases 0.000 claims abstract 2
- 230000009385 viral infection Effects 0.000 claims abstract 2
- 230000003834 intracellular effect Effects 0.000 claims 10
- 230000008054 signal transmission Effects 0.000 claims 6
- 210000001744 T-lymphocyte Anatomy 0.000 claims 4
- 101000914514 Homo sapiens T-cell-specific surface glycoprotein CD28 Proteins 0.000 claims 2
- 102100027213 T-cell-specific surface glycoprotein CD28 Human genes 0.000 claims 2
- 230000000139 costimulatory effect Effects 0.000 claims 2
- 244000045947 parasite Species 0.000 claims 2
- 239000012634 fragment Substances 0.000 claims 1
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Abstract
1. Композиция для адоптивной клеточной иммунотерапии, состоящая по существу изa) препарата хелперных Т-лимфоцитов из CD62L+ CD4+ клеток, генетически модифицированных для экспрессии антиген-реактивного химерного рецептора антигена; иb) (i) препарата цитотоксических Т-лимфоцитов из CD45RO+ CD62L+ CD8+ центральных клеток памяти, генетически модифицированных для экспрессии антиген-реактивного химерного рецептора антигена, или(ii) аутологичного антиген-специфического препарата цитотоксических Т-лимфоцитов, состоящего в основном из CD45RO+ CD62L+ CD8+ центральных клеток памяти, в которой генетически модифицированные CD4+ Τ-лимфоциты способны вызывать прямое распознавание антигена и увеличивать CD8+ клеточный иммунный ответ.2. Композиция для адоптивной клеточной иммунотерапии по п. 1, в которой антиген ассоциирован с заболеванием или состоянием, выбранным из солидной опухоли, гематологического злокачественного заболевания, меланомы или вирусной инфекции.3. Композиция для адоптивной клеточной иммунотерапии по п. 2, в которой антиген представляет собой ассоциированный с опухолью антиген клеточной поверхности.4. Композиция для адоптивной клеточной иммунотерапии по п. 1, в которой антиген представляет собой орфановый тирозинкиназный рецептор, выбранный из группы ROR1, tEGFR, Her2, L1-CAM, CD19, CD20, CD22, мезотелина, CEA или поверхностного антигена гепатита В.5. Композиция для адоптивной клеточной иммунотерапии по п. 1, в которой антиген представляет собой специфичный для патогена антиген клеточной поверхности, ассоциированный с заболеванием или нарушением, выбранным из группы, состоящей из антигенов ВИЧ, антигенов HCV, антигенов HBV, антигенов CMV и антигенов п
Claims (23)
1. Композиция для адоптивной клеточной иммунотерапии, состоящая по существу из
a) препарата хелперных Т-лимфоцитов из CD62L+ CD4+ клеток, генетически модифицированных для экспрессии антиген-реактивного химерного рецептора антигена; и
b) (i) препарата цитотоксических Т-лимфоцитов из CD45RO+ CD62L+ CD8+ центральных клеток памяти, генетически модифицированных для экспрессии антиген-реактивного химерного рецептора антигена, или
(ii) аутологичного антиген-специфического препарата цитотоксических Т-лимфоцитов, состоящего в основном из CD45RO+ CD62L+ CD8+ центральных клеток памяти, в которой генетически модифицированные CD4+ Τ-лимфоциты способны вызывать прямое распознавание антигена и увеличивать CD8+ клеточный иммунный ответ.
2. Композиция для адоптивной клеточной иммунотерапии по п. 1, в которой антиген ассоциирован с заболеванием или состоянием, выбранным из солидной опухоли, гематологического злокачественного заболевания, меланомы или вирусной инфекции.
3. Композиция для адоптивной клеточной иммунотерапии по п. 2, в которой антиген представляет собой ассоциированный с опухолью антиген клеточной поверхности.
4. Композиция для адоптивной клеточной иммунотерапии по п. 1, в которой антиген представляет собой орфановый тирозинкиназный рецептор, выбранный из группы ROR1, tEGFR, Her2, L1-CAM, CD19, CD20, CD22, мезотелина, CEA или поверхностного антигена гепатита В.
5. Композиция для адоптивной клеточной иммунотерапии по п. 1, в которой антиген представляет собой специфичный для патогена антиген клеточной поверхности, ассоциированный с заболеванием или нарушением, выбранным из группы, состоящей из антигенов ВИЧ, антигенов HCV, антигенов HBV, антигенов CMV и антигенов паразитов.
6. Композиция для адоптивной клеточной иммунотерапии по п. 1, в которой химерный рецептор содержит внеклеточный фрагмент одноцепочечного антитела и внутриклеточную сигнальную молекулу.
7. Композиция для адоптивной клеточной иммунотерапии по п. 6, в которой внутриклеточный модуль передачи сигнала химерного рецептора антигена содержит трансмембранный домен, внутриклеточный домен передачи сигнала CD3 и необязательно костимулирующий домен.
8. Композиция для адоптивной клеточной иммунотерапии по п. 7, в которой внутриклеточный домен передачи сигнала содержит CD28 или 4-1ВВ костимулирующий домен, связанный с внутриклеточным доменом CD3, или содержит трансмембранный и передающий сигнал домен из CD28, связанный с внутриклеточным доменом CD3.
9. Композиция для адоптивной клеточной иммунотерапии по п. 1, в которой внутриклеточный домен передачи сигнала химерного рецептора антигена в цитотоксических Т-клетках CD8+ по (b) (i) является таким же, как и внутриклеточный домен передачи сигнала химерного рецептора антигена в хелперных Т-клетках CD4+.
10. Композиция для адоптивной клеточной иммунотерапии по п. 1, в которой внутриклеточный домен передачи сигнала химерного рецептора антигена в цитотоксических Т-клетках CD8+ по (b) (i) отличается от внутриклеточного домена передачи сигнала химерного рецептора антигена в хелперных Т-клетках CD4+.
11. Композиция для адоптивной клеточной иммунотерапии по п. 1, в которой клеточный препарат генетически модифицированного хелперного Т-лимфоцита содержит по меньшей мере 80% CD62L+ CD4+ хелперных Τ-клеток.
12. Композиция для адоптивной клеточной иммунотерапии по п. 1, в которой клеточный препарат хелперного Т-лимфоцита состоит по существу из CD45RA+ CD45RO- CD62L+ CD4+ наивных клеток и CD45RA- CD45RO+ CD62L+ CD4+ клеток центральной памяти, генетически модифицированных для экспрессии антиген-реактивного химерного рецептора антигена.
13. Композиция для адоптивной клеточной иммунотерапии по п. 1, в которой клеточный препарат хелперного Т-лимфоцита состоит по существу из CD45RA+ CD45RO- CD62L+ CD4+ наивных клеток, генетически модифицированных для экспрессии антиген-реактивного химерного рецептора антигена.
14. Композиция для адоптивной клеточной иммунотерапии по п. 1, в которой клеточный препарат хелперного Т-лимфоцита содержит по меньшей мере 80% CD45RA+ CD45RO- CD62L+ CD4+ хелперных Τ-клеток.
15. Композиция для адоптивной клеточной иммунотерапии по любому из пп. 1-14, в которой обе клетки, Т-клетка CD8+ и Т-клетка CD4+, генетически модифицированы химерным рецептором антигена, содержащим домен тяжелой цепи антитела, который специфично связывает антиген клеточной поверхности, специфичный для патогена.
16. Композиция для адоптивной клеточной иммунотерапии по любому из пп. 1-14, в которой обе клетки, Т-клетка CD8+ и Т-клетка CD4+, генетически модифицированы сконструированным иммунорецептором, который специфически связывает ассоциированный с опухолью антиген.
17. Способ осуществления клеточной иммунотерапии у субъекта, имеющего заболевание или нарушение, включающий введение композиции по любому из пп. 1-14.
18. Способ по п. 17, где антиген представляет собой ассоциированный с опухолью антиген клеточной поверхности.
19. Способ по п. 18, где антиген представляет собой орфановый тирозинкиназный рецептор, выбранный из группы ROR1, tEGFR, Her2, L1-CAM, CD19, CD20, CD22, мезотелина, CEA или поверхностного антигена гепатита В.
20. Способ по п. 17, где антиген представляет собой антиген клеточной поверхности, специфичный для патогена.
21. Способ по п. 20, антиген клеточной поверхности, специфичный для патогена, выбран из группы, состоящей из антигенов ВИЧ, антигенов HCV, антигенов HBV, антигенов CMV и антигенов паразитов.
22. Способ по п. 17, где клеточный препарат генетически модифицированного хелперного Т-лимфоцита содержит по меньшей мере 80% CD62L+ CD4+ хелперных Τ-клеток.
23. Способ по п. 21, где по меньшей мере 80% CD62L+ CD4+ хелперных Т-клеток представляют собой CD45RA+ CD45RO- CD62L+ CD4+ наивные хелперные Τ-клетки.
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