RU2019133327A - Способ лечения побочного эффекта терапии Т-клетками с химерными антигенными рецепторами (CAR) - Google Patents
Способ лечения побочного эффекта терапии Т-клетками с химерными антигенными рецепторами (CAR) Download PDFInfo
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Claims (18)
1. Способ лечения побочного эффекта CAR Т-клеточной (Т-клетками с химерными антигенными рецепторами) терапии, включающий введение мезенхимальных стволовых клеток (MSC) субъекту, который получал или получает CAR Т-клеточную терапию.
2. Применение мезенхимальных стволовых клеток (MSC) в изготовлении лекарственного средства для лечения побочного эффекта CAR Т-клеточной терапии у субъекта, который получал или получает CAR Т-клеточную терапию.
3. Способ по п. 1 или применение по п. 2, где MSC имеет фенотип CD73+CD105+CD90+CD146+CD44+CD10+CD31-CD45-.
4. Способ или применение по любому из пп. 1-3, где субъекту вводят от примерно 1×106 MSC/кг до примерно 1×107 MSC/кг.
5. Способ или применение по любому из пп. 1-4, где MSC экспрессирует miR-145-5р, miR-181b-5p и miR-214-3р, но не miR-127-3р и miR-299-5p.
6. Способ или применение по любому из пп. 1-5, где лечение включает введение субъекту от примерно 1×108 до примерно 5×108 MSC.
7. Способ или применение по любому из пп 1-6, где лечение включает введение MSC до, во время или после получения субъектом CAR Т-клеточной терапии.
8. Способ или применение по любому из пп. 1-7, где лечение включает введение MSC после получения субъектом CAR Т-клеточной терапии.
9. Способ или применение по п. 8, где лечение включает введение MSC в пределах от 24 часов до 72 часов после получения субъектом CAR Т-клеточной терапии.
10. Способ или применение по любому из пп. 1-9, где побочный эффект или симптом представляет собой: синдром высвобождения цитокинов (CRS), возможно высвобождение интерлейкина-6 (IL-6), интерферона-γ (IFN-γ), фактора некроза опухоли (TNF), IL-2, IL-2-рецептора α, IL-8, IL-10 или гранулоцитарно-макрофагального колониестимулирующего фактора (GMCSF); синдром активации макрофагов (MAS); целенаправленный, не связанный с раком эффект, возможно В-клеточную аплазию; синдром лизиса опухоли (TLS); нейротоксичность, возможно отек головного мозга; или анафилаксию.
11. Способ или применение по любому из пп. 1-10, где CAR Т-клеточная терапия предназначена для лечения: диффузной крупноклеточной В-клеточной лимфомы (DLBCL); неходжкинской лимфомы (NHL); первичной медиастинальной В-клеточной лимфомы (PMBCL); хронического лимфоцитарного лейкоза (CLL); трансформированной фолликулярной лимфомы (TFL); множественной миеломы (ММ); мантийноклеточной лимфомы (MCL); острого миелолейкоза (AML); или острого лимфобластного лейкоза (ALL).
12. Способ или применение по любому из пп. 1-11, где CAR представляет собой анти-CD19 CAR.
13. Способ или применение по любому из пп. 1-12, где субъект представляет собой млекопитающее, возможно человека.
14. Терапевтическая композиция для лечения, ослабления или уменьшения побочного эффекта CAR Т-клеточной терапии у субъекта-млекопитающего, которая содержит мезенхимальную стволовую клетку (MSC), полученную способом, включающим:
(а) культивирование первичной мезодермальной клетки в среде для формирования мезенхимальных колоний (M-CFM), содержащей LiCl и FGF2 (фактор роста фибробластов 2), но не содержащей PDGF (тромбоцитарный фактор роста), в условиях с нормальным содержанием кислорода в течение достаточного времени для формирования мезенхимальной колонии; и
(б) культивирование мезенхимальной колонии со стадии (а) в прикрепленном состоянии с получением MSC,
где MSC со стадии (б) экспрессирует miR-145-5p, miR-181b-5p и miR-214-3р, но не miR-127-3р и miR-299-5p, и/или имеет фенотип CD73+CD105+CD90+CD146+CD44+CD10+CD31-CD45-.
15. Контейнер, содержащий терапевтическую композицию по п. 14.
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