JP2019526579A - T細胞癌を標的とする為の方法及び組成物 - Google Patents
T細胞癌を標的とする為の方法及び組成物 Download PDFInfo
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Abstract
Description
ABRAXANE(登録商標)(ABX)は、0.9%の食塩水を含むムロモナブ-CD3(OKT3)中で懸濁される。混合物は、30分間、室温で(又は示された温度で)、インキュベーションされて、粒子形成をもたらす。ABX:OKT3複合体の粒子サイズを測定する為のマスターサイザー(Mastersizer)実験の為に、10mgのABXが、0〜25mg/mlの濃度で、OKT3中に懸濁される。
Claims (54)
- 外表面を有する複数のナノ粒子を含むナノ粒子組成物であって、該複数のナノ粒子のそれぞれが、
(a)キャリアータンパク質、
(b)T細胞抗原結合部位を有する結合剤、及び
(c)治療的に有効な量のパクリタキセル
を含み、
ここで、水性溶液で再構成すると、上記結合剤の上記抗原結合部位が、イン・ビボでT細胞抗原に結合することができる、
上記ナノ粒子組成物。 - 上記ナノ粒子が約100〜約1000の結合剤を含む、請求項1に記載のナノ粒子組成物。
- 上記抗原結合部位がT細胞受容体に結合することができる、請求項1に記載のナノ粒子組成物。
- 上記抗原結合部位が、CD2、CD3、CD4、CD5、CD8、CD25、CD30、CD40、CD52、CD122又はCCR4から選択される抗原に結合する、請求項3に記載のナノ粒子組成物。
- 上記ナノ粒子が凍結乾燥されている、請求項1に記載のナノ粒子組成物。
- 上記組成物が、約20℃〜約25℃で、約12ヶ月以上まで安定である、請求項1〜5のいずれか1項に記載のナノ粒子組成物。
- 上記結合剤が、スリピズマブ、ムロモナブ-CD3(OKT3)、Leu 1、ザノリムマブ、ザノリムマブ、ブレンツキシマブ・ベドチン、Mik-β1、KW-0761、又はそれらの組み合わせを含む、請求項1〜5のいずれか1項に記載のナノ粒子組成物。
- 上記結合剤がムロモナブ-CD3(OKT3)である、請求項1〜5のいずれか1項に記載のナノ粒子組成物。
- 上記抗原結合部位が、アプタマー、受容体リガンド、Fabフラグメント、又はそれらの組み合わせを含む、請求項1〜5のいずれか1項に記載のナノ粒子組成物。
- 上記組成物が1以上の追加の癌治療剤を含む、請求項1〜5のいずれか1項に記載のナノ粒子組成物。
- 上記追加の癌治療剤が、アビラテロン、ベンダムスチン、ボルテゾミブ、カルボプラチン、カバジタキセル、シスプラチン、クロラムブシル、ダサチニブ、ドセタキセル、ドキソルビシン、エピルビシン、エルロチニブ、エトポシド、エベロリムス、ゲフィチニブ、イダルビシン、イマチニブ、ヒドロキシウレア、イマチニブ、ラパチニブ、リュープロレリン、メルファラン、メトトレキサート、ミトキサントロン、ネダプラチン、ニロチニブ、オキサリプラチン、パゾパニブ、ペメトレキセド、ピコプラチン、ロミデプシン、サトラプラチン、ソラフェニブ、ベムラフェニブ、スニチニブ、テニポシド、トリプラチン、ビンブラスチン、ビノレルビン、ビンクリスチン又はシクロホスファミドを含む、請求項10に記載のナノ粒子組成物。
- 上記ナノ粒子の約50%未満がオリゴマーである、請求項1〜11のいずれか1項に記載のナノ粒子組成物。
- 上記組成物中に存在する上記ナノ粒子の40%未満がオリゴマーである、請求項1〜11のいずれか1項に記載のナノ粒子組成物。
- 上記組成物中に存在する上記ナノ粒子の30%未満がオリゴマーである、請求項1〜11のいずれか1項に記載のナノ粒子組成物。
- 上記組成物中に存在する上記ナノ粒子の20%未満がオリゴマーである、請求項1〜11のいずれか1項に記載のナノ粒子組成物。
- 上記組成物中に存在する上記ナノ粒子の10%未満がオリゴマーである、請求項1〜11のいずれか1項に記載のナノ粒子組成物。
- 上記組成物中に存在する上記ナノ粒子の5%未満がオリゴマーである、請求項1〜11のいずれか1項に記載のナノ粒子組成物。
- 上記ナノ粒子の平均サイズが90nm〜800nmである、請求項1〜5のいずれか1項に記載のナノ粒子組成物。
- 上記キャリアータンパク質が、アルブミン、ゼラチン、エラスチン、グリアジン、レグミン、ゼイン、ダイズタンパク質、ミルクタンパク質、ホエータンパク質、又はそれらの組み合わせを含む、請求項1に記載のナノ粒子組成物。
- 上記キャリアータンパク質が抗体結合モチーフを含む、請求項19に記載のナノ粒子組成物。
- 上記キャリアータンパク質がアルブミンである、請求項20に記載のナノ粒子組成物。
- 上記アルブミンがヒト血清アルブミンである、請求項21に記載のナノ粒子組成物。
- 上記アルブミンが組み換えヒト血清アルブミンである、請求項21に記載のナノ粒子組成物。
- 上記組成物が、静脈内送達の為に製剤化されている、請求項1〜23のいずれか1項に記載のナノ粒子組成物。
- 上記ナノ粒子が、約1x10-11M〜約1x10-8Mの解離定数を有する、請求項1〜5のいずれか1項に記載のナノ粒子組成物。
- T細胞癌の細胞を処置する為の方法であって、該癌の細胞を有効量のナノ粒子組成物と接触させることを含み、該ナノ粒子組成物は、該癌の細胞を処置する為に十分な期間に亘って該細胞と接触し続けられ、ここで、上記ナノ粒子組成物は、外表面を有する複数のナノ粒子を含み、該複数のナノ粒子のそれぞれが、
(a)キャリアータンパク質、
(b)T細胞抗原結合部位を有する結合剤、及び
(c)治療的に有効な量のパクリタキセル
を含み、
上記結合剤の上記抗原結合部位が、イン・ビボでT細胞抗原に結合することができる、
上記方法。 - 上記ナノ粒子が約100〜約1000の結合剤を含む、請求項26に記載の方法。
- 上記抗原結合部位がT細胞受容体(TCR)に結合する、請求項26に記載の方法。
- 上記抗原結合部位が、CD2、CD3、CD4、CD5、CD8、CD25、CD30、CD40、CD52、CD122又はCCR4から選択される抗原に結合する、請求項26に記載の方法。
- 上記抗原がCD2又はCD3である、請求項29に記載の方法。
- 上記ナノ粒子組成物が、投与前に水性溶液中で再構成される凍結されたナノ粒子組成物である、請求項27に記載の方法。
- 上記組成物が、約20℃〜約25℃で、約12ヶ月以上まで安定である、請求項27に記載の方法。
- 上記結合剤が、スリピズマブ、OKT3、Leu 1、ザノリムマブ、ザノリムマブ、ブレンツキシマブ・ベドチン、Mik-β1、KW-0761、又はそれらの組み合わせを含む、請求項27〜32のいずれか1項に記載の方法。
- 上記結合剤がムロモナブ-CD3(OKT3)である、請求項27〜32のいずれか1項に記載の方法。
- 上記抗原結合部位が、アプタマー、受容体リガンド又はFabフラグメントである、請求項27〜32のいずれか1項に記載の方法。
- 上記組成物が1以上の追加の癌治療剤を含む、請求項27〜32のいずれか1項に記載の方法。
- 上記追加の癌治療剤が、アビラテロン、ベンダムスチン、ボルテゾミブ、カルボプラチン、カバジタキセル、シスプラチン、クロラムブシル、ダサチニブ、ドセタキセル、ドキソルビシン、エピルビシン、エルロチニブ、エトポシド、エベロリムス、ゲフィチニブ、イダルビシン、イマチニブ、ヒドロキシウレア、イマチニブ、ラパチニブ、リュープロレリン、メルファラン、メトトレキサート、ミトキサントロン、ネダプラチン、ニロチニブ、オキサリプラチン、パクリタキセル、パゾパニブ、ペメトレキセド、ピコプラチン、ロミデプシン、サトラプラチン、ソラフェニブ、ベムラフェニブ、スニチニブ、テニポシド、トリプラチン、ビンブラスチン、ビノレルビン、ビンクリスチン又はシクロホスファミドを含む、請求項36に記載の方法。
- 上記ナノ粒子の約50%未満がオリゴマーである、請求項27〜37のいずれか1項に記載の方法。
- 上記組成物中に存在する上記ナノ粒子の40%未満がオリゴマーである、請求項27〜37のいずれか1項に記載の方法。
- 上記組成物中に存在する上記ナノ粒子の30%未満がオリゴマーである、請求項27〜37のいずれか1項に記載の方法。
- 上記組成物中に存在する上記ナノ粒子の20%未満がオリゴマーである、請求項27〜37のいずれか1項に記載の方法。
- 上記組成物中に存在する上記ナノ粒子の10%未満がオリゴマーである、請求項27〜37のいずれか1項に記載の方法。
- 上記組成物中に存在する上記ナノ粒子の5%未満がオリゴマーである、請求項27〜37のいずれか1項に記載の方法。
- 上記ナノ粒子の平均サイズが90nm〜800nmである、請求項27〜43のいずれか1項に記載の方法。
- 上記ナノ粒子の平均サイズが約90nm〜約160nmである、請求項27〜32のいずれか1項に記載の方法。
- 上記キャリアータンパク質が、アルブミン、ゼラチン、エラスチン、グリアジン、レグミン、ゼイン、ダイズタンパク質、ミルクタンパク質、ホエータンパク質、又はそれらの組み合わせを含む、請求項27〜45のいずれか1項に記載の方法。
- 上記キャリアータンパク質がアルブミンである、請求項46に記載の方法。
- 上記アルブミンがヒト血清アルブミンである、請求項47に記載の方法。
- 上記アルブミンが組み換えヒト血清アルブミンである、請求項47に記載の方法
- 上記組成物が、静脈内送達の為に製剤化される、請求項27〜49のいずれか1項に記載の方法。
- 上記ナノ粒子が、約1x10-11M〜約1x10-8Mの解離定数を有する、請求項27〜32のいずれか1項に記載の方法。
- 上記ナノ粒子組成物の治療的に有効な量が、約75mg/m2〜約175mg/m2のパクリタキセルを含む、請求項27〜32のいずれか1項に記載の方法。
- 上記T細胞癌が、末梢T細胞リンパ腫、未分化大細胞リンパ腫、血管免疫芽細胞性リンパ腫皮膚T細胞リンパ腫、成人T細胞白血病/リンパ腫(ATLL)、腸症型T細胞リンパ腫、造血性ガンマデルタT細胞リンパ腫、芽細胞性NK細胞リンパ腫、リンパ芽球性リンパ腫、鼻NK/T細胞リンパ腫、処置に関連したT細胞リンパ腫、又はそれらの組み合わせを含む、請求項27〜52のいずれか1項に記載の方法。
- 上記T細胞癌がT細胞リンパ腫である、請求項27〜52のいずれか1項に記載の方法。
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