RU2018113510A - Химерные рецепторы антигена, нацеленные на psca - Google Patents

Химерные рецепторы антигена, нацеленные на psca Download PDF

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RU2018113510A
RU2018113510A RU2018113510A RU2018113510A RU2018113510A RU 2018113510 A RU2018113510 A RU 2018113510A RU 2018113510 A RU2018113510 A RU 2018113510A RU 2018113510 A RU2018113510 A RU 2018113510A RU 2018113510 A RU2018113510 A RU 2018113510A
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amino acid
variant
domain
acid modifications
modifications
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RU2018113510A
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RU2018113510A3 (ru
RU2759879C2 (ru
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Сол Дж. ПРАЙСМЕН
Кристин Е. БРАУН
Стивен Дж. ФОРМЭН
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Сити Оф Хоуп
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Claims (28)

1. Молекула нуклеиновой кислоты, кодирующая химерный рецептор антигена, где химерный рецептор антигена содержит: scFv, связывающийся с PSCA, или его вариант, имеющий 1-5 модификаций аминокислот; трансмембранный домен, выбранный из: трансмембранного домена CD4 или его варианта, имеющего 1-5 модификаций аминокислот, трансмембранного домена CD8 или его варианта, имеющего 1-5 модификаций аминокислот, трансмембранного домена CD28 или его варианта, имеющего 1-5 модификаций аминокислот; костимулирующий домен, выбранный из: костимулирующего домена 4-IBB или его варианта, имеющего 1-5 модификаций аминокислот, и костимулирующего домена CD28 или его варианта, имеющего 1-5 модификаций аминокислот; домен сигнализации CD3ζ или его вариант, имеющий 1-5 модификаций аминокислот; и спейсерную область, имеющую 20-150 аминокислот, расположенную между scFv и трансмембранным доменом.
2. Молекула нуклеиновой кислоты по п. 1, где костимулирующий домен выбран из группы, состоящей из: костимулирующего домена 4-IBB и его вариантов, имеющих 1-5 модификаций аминокислот.
3. Молекула нуклеиновой кислоты по п. 1, где трансмембранный домен представляет собой трансмембранный домен CD4 или его вариант, имеющий 1-5 модификаций аминокислот.
4. Молекула нуклеиновой кислоты по п. 1, где трансмембранный домен представляет собой трансмембранный домен CD4.
5. Молекула нуклеиновой кислоты по п. 1, где химерный рецептор антигена содержит два разных костимулирующих домена, выбранных из группы, состоящей из: костимулирующего домена CD28 или его варианта, имеющего 1-5 модификаций аминокислот, костимулирующего домена 4-IBB или его варианта, имеющего 1-5 модификаций аминокислот, и костимулирующего домена ОХ40 или его варианта, имеющего 1-5 модификаций аминокислот.
6. Молекула нуклеиновой кислоты по п. 5, где химерный рецептор антигена содержит scFv, связывающийся с PSCA, имеющий аминокислотную последовательность SEQ ID NO: 38.
7. Молекула нуклеиновой кислоты по п. 1, где химерный рецептор антигена содержит: scFv, связывающийся с PSCA, или его вариант, имеющий 1-2 модификации аминокислот; трансмембранный домен, выбранный из: трансмембранного домена CD4 или его варианта, имеющего 1-2 модификации аминокислот, трансмембранного домена CD8 или его варианта, имеющего 1-2 модификации аминокислот, трансмембранного домена CD28 или его варианта, имеющего 1-2 модификации аминокислот, и трансмембранного домена CD3ζ или его варианта, имеющего 1-2 модификации аминокислот; костимулирующий домен 4-IBB или его вариант, имеющий 1-2 модификации аминокислот; и домен сигнализации CD3ζ или его вариант, имеющий 1-2 модификации аминокислот; и спейсерную область, имеющую 20-150 аминокислот, расположенную между scFv и трансмембранным доменом.
8. Молекула нуклеиновой кислоты по п. 1 или 7, где спейсерная область содержит аминокислотную последовательность, выбранную из группы, состоящей из SEQ ID NO: 2-12, или ее вариант, имеющий 1-5 модификаций аминокислот.
9. Молекула нуклеиновой кислоты по п. 1 или 7, где спейсер содержит шарнирную область IgG.
10. Молекула нуклеиновой кислоты по п. 1 или 7, где спейсер содержит 10-50 аминокислот.
11. Молекула нуклеиновой кислоты по п. 1 или 7, где костимулирующий домен 4-IBB содержит аминокислотную последовательность SEQ ID NO:24 или ее вариант, имеющий 1-5 модификаций аминокислот.
12. Молекула нуклеиновой кислоты по п. 1, где домен сигнализации CD3ζ содержит аминокислотную последовательность SEQ ID NO:21.
13. Молекула нуклеиновой кислоты по п. 1 или 7, где линкер из 3-15 аминокислот располагается между костимулирующим доменом и доменом сигнализации CD3ζ, или ее вариант.
14. Молекула нуклеиновой кислоты по п. 1, где молекула нуклеиновой кислоты экспрессирует полипептид, содержащий аминокислотную последовательность, выбранную из SEQ ID NO:26-37, или ее вариант, имеющий 1-5 модификаций аминокислот.
15. Молекула нуклеиновой кислоты по п. 1, где 1-5 модификаций аминокислот представляют собой замены.
16. Молекула нуклеиновой кислоты по п. 7, где 1-2 модификации аминокислот представляют собой замены.
17. Популяция человеческих Т-клеток, трансдуцированных вектором, содержащим экспрессионную кассету, кодирующую химерный рецептор антигена, где химерный рецептор антигена содержит: scFv, связывающийся с PSCA, или его вариант, имеющий 1-2 модификации аминокислот, или его вариант, имеющий 1-5 модификаций аминокислот; трансмембранный домен, выбранный из: трансмембранного домена CD4 или его варианта, имеющего 1-5 модификаций аминокислот, трансмембранного домена CD8 или его варианта, имеющего 1-5 модификаций аминокислот, трансмембранного домена CD28 или его варианта, имеющего 1-5 модификаций аминокислот; костимулирующий домен, выбранный из: костимулирующего домена 4-IBB или его варианта, имеющего 1-5 модификаций аминокислот, и костимулирующего домена ОХ40 или его варианта, имеющего 1-5 модификаций аминокислот; домен сигнализации CD3ζ, или его вариант, имеющий 1-5 модификаций аминокислот; и спейсерную область, имеющую 20-150 аминокислот, расположенную между scFv и трансмембранным доменом.
18. Популяция человеческих Т-клеток, содержащих вектор, экспрессирующий химерный рецептор антигена, содержащий аминокислотную последовательность, выбранную из SEQ ID NO: 26-37, или ее вариант, имеющий 1-5 модификаций аминокислот.
19. Популяция человеческих Т-клеток по п. 18, где 1-5 модификаций аминокислот представляют собой замены.
20. Популяция человеческих Т-клеток по п. 17, где Т-клетки состоят из популяции центральных Т-клеток памяти.
21. Способ лечения рака у пациента, включающий введение популяции аутологичных или аллогенных человеческих Т-клеток, трансдуцированных вектором, содержащим экспрессионную кассету, кодирующую химерный рецептор антигена, где химерный рецептор антигена содержит аминокислотную последовательность, выбранную из SEQ ID NO: 26-37, или ее вариант, имеющий 1-5 модификаций аминокислот.
22. Способ по п. 21, в котором популяция человеческих Т-клеток содержит центральные Т-клетки памяти.
23. Способ по п. 21, в котором раковое заболевание представляет собой рак простаты.
24. Способ по п. 21, в котором раковое заболевание представляет собой метастаз в кости рака простаты.
25. Способ по п. 21, в котором раковое заболевание представляет собой рак поджелудочной железы.
26. Способ по п. 21, в котором трансдуцированные человеческие Т-клетки были получены способом, включающим получение Т-клеток от пациента, обработку Т-клеток для выделения центральных Т-клеток памяти и трансдуцирование по меньшей мере части центральных клеток памяти вирусным вектором, содержащим экспрессионную кассету, кодирующую химерный рецептор антигена, где химерный рецептор антигена содержит аминокислотную последовательность, выбранную из SEQ ID NO: 26-37, или ее вариант, имеющий 1-5 модификаций аминокислот.
27. Молекула нуклеиновой кислоты, кодирующая полипептид, содержащий аминокислотную последовательность, которая является по меньшей мере на 95% идентичной аминокислотной последовательности, выбранной из SEQ ID NO: 26-37.
28. Т-клетка, экспрессирующая полипептид, содержащий аминокислотную последовательность, которая является идентичной аминокислотной последовательности, выбранной из SEQ ID NO: 26-37, или ее варианту, имеющему 1-5 модификаций аминокислот.
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