JP2017122111A5 - - Google Patents
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- JP2017122111A5 JP2017122111A5 JP2017038086A JP2017038086A JP2017122111A5 JP 2017122111 A5 JP2017122111 A5 JP 2017122111A5 JP 2017038086 A JP2017038086 A JP 2017038086A JP 2017038086 A JP2017038086 A JP 2017038086A JP 2017122111 A5 JP2017122111 A5 JP 2017122111A5
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Claims (16)
- 方法における使用のための、
（ｉ）免疫抑制剤に結合された合成ナノキャリアの第１の集団と、
（ｉｉ）抗原のＭＨＣクラスＩ拘束性および／またはＭＨＣクラスＩＩ拘束性エピトープと
を含む組成物であって、前記方法が、
（ａ）前記組成物を、被験体における抗原特異的なＣＤ８＋制御性Ｔ細胞を生成するのに有効な量で投与する工程；または
（ｂ）前記組成物を投与することによって、被験体における抗原特異的なＣＤ８＋制御性Ｔ細胞を生成する工程；または
（ｃ）一人以上の被験体における抗原特異的なＣＤ８＋制御性Ｔ細胞を生成することが既に示されたプロトコルに従って前記組成物を被験体に投与する工程
を含む、前記組成物。 - （ａ）前記方法が、（ｉ）前記被験体を提供または同定する工程；（ｉｉ）前記組成物の前記投与の前および／または前記投与の後に、前記被験体における抗原特異的なＣＤ８＋制御性Ｔ細胞の生成を評価する工程；および／または（ｉｉｉ）移植可能な移植片または治療用タンパク質を前記被験体に投与する工程；（ｉｖ）前記合成ナノキャリアの第１の集団および前記抗原のＭＨＣクラスＩ拘束性および／またはＭＨＣクラスＩＩ拘束性エピトープを含む前記組成物の１つ以上の維持投与量を、前記被験体に投与する工程を更に含む；および／または
（ｂ）前記抗原が、治療用タンパク質、自己抗原またはアレルゲンであるか、或いは炎症性疾患、自己免疫疾患、臓器若しくは組織拒絶反応または移植片対宿主病と関連する；および／または
（ｃ）前記被験体が、（ｉ）炎症性疾患、自己免疫疾患、アレルギー、臓器若しくは組織拒絶反応または移植片対宿主病に罹患しているかまたは罹患するリスクがある；および／または（ｉｉ）移植を行ったかまたは移植を行う予定である；および／または（ｉｉｉ）前記被験体に投与されているかまたは投与される予定である治療用タンパク質に対する望ましくない免疫応答を有するかまたは有するリスクがある；および／または
（ｄ）（ｉ）前記合成ナノキャリアおよび／または前記抗原のＭＨＣクラスＩ拘束性および／またはＭＨＣクラスＩＩ拘束性エピトープの前記投与が、静脈内、腹腔内、経粘膜、経口、皮下、経肺、鼻腔内、皮内または筋肉内投与によって、例えば、吸入或いは静脈内、皮下または経粘膜投与によって、行われる；および／または（ｉｉ）前記移植可能な移植片または治療用タンパク質の前記投与が、前記治療用タンパク質が１個以上の細胞として提供される場合、非経口、動脈内、鼻腔内または静脈内投与によって、或いはリンパ節または前眼房への注射によって、或いは対象とする臓器または組織への局所投与によって行われる；および／または
（ｅ）前記免疫抑制剤が、スタチン、ｍＴＯＲ阻害剤、ＴＧＦ−βシグナル伝達剤、コルチコステロイド、ミトコンドリア機能の阻害剤、Ｐ３８阻害剤、ＮＦ−κβ阻害剤、アデノシン受容体アゴニスト、プロスタグランジンＥ２アゴニスト、ホスホジエステラーゼ４阻害剤、ＨＤＡＣ阻害剤またはプロテアソーム阻害剤を含み、例えば、前記ｍＴＯＲ阻害剤がラパマイシンである；および／または
（ｆ）前記免疫抑制剤の負荷が、前記合成ナノキャリアの第１の集団全体を平均して、０．０００１％〜５０％（重量／重量）、例えば０．１％〜１０％であり、任意に、前記免疫抑制剤の負荷が、前記合成ナノキャリアの第１の集団全体を平均して、少なくとも２％であるが２５％（重量／重量）以下である、請求項１に記載の組成物。 - 前記第１の集団の前記合成ナノキャリアが、脂質ナノ粒子、ポリマーナノ粒子、金属ナノ粒子、界面活性剤ベースのエマルジョン、デンドリマー、バッキーボール、ナノワイヤ、ウイルス様粒子またはペプチド若しくはタンパク質粒子を含み、任意に：
（ａ）前記第１の集団の前記合成ナノキャリアが、脂質ナノ粒子を含み、例えば、前記第１の集団の前記合成ナノキャリアが、リポソームを含む；
（ｂ）前記第１の集団の前記合成ナノキャリアが、金属ナノ粒子を含み、例えば、前記金属ナノ粒子が金ナノ粒子を含む；
（ｃ）前記第１の集団の前記合成ナノキャリアが、ポリマーナノ粒子を含み、例えば：（ｉ）前記ポリマーナノ粒子が、非メトキシ末端プルロニックポリマーであるポリマーを含む；および／または（ｉｉ）前記ポリマーナノ粒子が、ポリエステル、ポリエーテルに結合されたポリエステル、ポリアミノ酸、ポリカーボネート、ポリアセタール、ポリケタール、多糖、ポリエチルオキサゾリンまたはポリエチレンイミンを含み、例えば、前記ポリエステルが、ポリ（乳酸）、ポリ（グリコール酸）、ポリ（乳酸−コ−グリコール酸）またはポリカプロラクトンを含むか、および／または、前記ポリマーナノ粒子が、ポリエステルおよびポリエーテルに結合されたポリエステルを含み、例えば、前記ポリエーテルが、ポリエチレングリコールまたはポリプロピレングリコールを含む、請求項１または２に記載の組成物。 - （ａ）前記第１の集団の前記合成ナノキャリアの動的光散乱を用いて得られる粒度分布の平均が、（ｉ）１００ｎｍを超える；（ｉｉ）１５０ｎｍを超える；（ｉｉｉ）２００ｎｍを超える；（ｉｖ）２５０ｎｍを超える；または（ｖ）３００ｎｍを超える直径である；および／または（ｂ）前記第１の集団の前記合成ナノキャリアのアスペクト比が、１：１、１：１．２、１：１．５、１：２、１：３、１：５、１：７または１：１０を超える、請求項１〜３のいずれか一項に記載の組成物。
- 前記方法が、前記生成された抗原特異的なＣＤ８＋制御性Ｔ細胞を収集する工程を更に含み、任意に：
（ａ）前記収集された抗原特異的なＣＤ８＋制御性Ｔ細胞を含む剤形を作製する工程；および／または
（ｂ）前記収集された抗原特異的なＣＤ８＋制御性Ｔ細胞を被験体が投与に利用できるようにするかまたは剤形を被験体が投与に利用できるようにする工程；および／または
（ｃ）移植可能な移植片または治療用タンパク質を、前記収集された抗原特異的なＣＤ８＋制御性Ｔ細胞または剤形に含める工程
を更に含む、請求項１〜４のいずれか一項に記載の組成物。 - 少なくとも８０％、少なくとも９０％、または少なくとも９５％の前記合成ナノキャリアの第１の集団が、前記合成ナノキャリアの平均直径の５％、１０％、または２０％の範囲内の最小寸法または最大寸法を有する、請求項１〜５のいずれか一項に記載の組成物。
- 抗原のＭＨＣクラスＩ拘束性および／またはＭＨＣクラスＩＩ拘束性エピトープが、いずれの合成ナノキャリアにも結合されていない、請求項１〜６のいずれか一項に記載の組成物。
- （ｉ）免疫抑制剤に結合された合成ナノキャリアの第１の集団を生成する工程と、
（ｉｉ）抗原のＭＨＣクラスＩ拘束性および／またはＭＨＣクラスＩＩ拘束性エピトープを生成する工程と
を含む方法であって、任意に：
（ａ）前記方法が、前記合成ナノキャリアの第１の集団および前記抗原のＭＨＣクラスＩ拘束性および／またはＭＨＣクラスＩＩ拘束性エピトープを含む剤形を作製する工程を更に含む；および／または
（ｂ）前記方法が、前記合成ナノキャリアの第１の集団および前記抗原のＭＨＣクラスＩ拘束性および／またはＭＨＣクラスＩＩ拘束性エピトープを含む組成物または前記剤形を、被験体が投与に利用できるようにする工程を更に含む；および／または
（ｃ）前記方法が、前記合成ナノキャリアの第１の集団および前記抗原のＭＨＣクラスＩ拘束性および／またはＭＨＣクラスＩＩ拘束性エピトープを含む組成物による、抗原特異的なＣＤ８＋制御性Ｔ細胞の生成を評価する工程を更に含む；および／または
（ｄ）前記組成物が、抗原特異的なＣＤ８＋制御性Ｔ細胞を生成するのに有効な量である；および／または
（ｅ）生成される、前記合成ナノキャリアの第１の集団および前記抗原のＭＨＣクラスＩ拘束性および／またはＭＨＣクラスＩＩ拘束性エピトープが、請求項１〜７のいずれか一項に記載されるとおりである、前記方法。 - 組成物または剤形を生成するためのプロセスであって：
（ｉ）合成ナノキャリアの第１の集団を免疫抑制剤に結合する工程と、
（ｉｉ）抗原のＭＨＣクラスＩ拘束性および／またはＭＨＣクラスＩＩ拘束性エピトープを提供する工程と
を含み、任意に、請求項８に記載の方法において規定される工程を含む、前記プロセス。 - 治療または予防における、単離された抗原特異的なＣＤ８＋制御性Ｔ細胞を含む組成物の使用であって、前記単離された抗原特異的なＣＤ８＋制御性Ｔ細胞が：
（ａ）（ｉ）免疫抑制剤に結合された合成ナノキャリアの第１の集団と、（ｉｉ）抗原のＭＨＣクラスＩ拘束性および／またはＭＨＣクラスＩＩ拘束性エピトープとを含む組成物を投与することによって、被験体における抗原特異的なＣＤ８＋制御性Ｔ細胞を生成する工程と；（ｂ）前記生成された抗原特異的なＣＤ８＋制御性Ｔ細胞を収集する工程とを含むプロセスによって得られる、前記使用。 - 治療または予防における、単離された抗原特異的なＣＤ８＋制御性Ｔ細胞を含む剤形の使用であって、前記単離された抗原特異的なＣＤ８＋制御性Ｔ細胞が：
（ａ）（ｉ）免疫抑制剤に結合された合成ナノキャリアの第１の集団と、（ｉｉ）抗原のＭＨＣクラスＩ拘束性および／またはＭＨＣクラスＩＩ拘束性エピトープとを含む組成物を投与することによって、被験体における抗原特異的なＣＤ８＋制御性Ｔ細胞を生成する工程と；（ｂ）前記生成された抗原特異的なＣＤ８＋制御性Ｔ細胞を収集する工程とを含むプロセスによって得られる、前記使用。 - 治療または予防における、（ｉ）免疫抑制剤に結合された合成ナノキャリアの第１の集団と、（ｉｉ）抗原のＭＨＣクラスＩ拘束性および／またはＭＨＣクラスＩＩ拘束性エピトープとを含む組成物の使用。
- 前記組成物が、請求項１〜７のいずれか一項に記載されるとおりである、請求項１２に記載の使用。
- 治療または予防における、（ｉ）免疫抑制剤に結合された合成ナノキャリアの第１の集団と、（ｉｉ）抗原のＭＨＣクラスＩ拘束性および／またはＭＨＣクラスＩＩ拘束性エピトープとを含む剤形の使用。
- 抗原のＭＨＣクラスＩ拘束性および／またはＭＨＣクラスＩＩ拘束性エピトープが、いずれの合成ナノキャリアにも結合されていない、請求項１０〜１４のいずれか一項に記載の使用。
- 被験体における寛容原性免疫応答を促進するかまたは抗原特異的なＣＤ８＋制御性Ｔ細胞を生成することにおける、請求項１〜７のいずれか一項に記載の組成物の使用。
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