JP5144250B2 - 細胞治療処方方法および組成物 - Google Patents
細胞治療処方方法および組成物 Download PDFInfo
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Description
本発明は、注入のためにエキソビボ調製されたT細胞を処方するための方法に関する。
細胞治療法は、腫瘍、ウイルスおよび細菌病原体に対する宿主免疫応答を増強するために開発されてきた。細胞治療法は、多くの場合、T細胞のエキソビボ活性化および増殖を含む。これらの型の処置の例としては、腫瘍浸潤リンパ球(TIL)細胞(Rosenbergに対して発行された米国特許第5,126,132号を参照のこと)、細胞傷害性T細胞(Caiらに対して発行された米国特許第6,255,073号;およびCelisらに対して発行された米国特許第5,846,827号を参照のこと)、増殖された腫瘍排出リンパ節細胞(Termanに対して発行された米国特許第6,251,385号を参照のこと)、および種々の他のリンパ球調製物(Bellらに対して発行された米国特許第6,194,207号;Ochoaらに対して発行された米国特許第5,443,983号;Riddellらに対して発行された米国特許第6,040,177号;Babbittらに対して発行された米国特許第5,766,920号を参照のこと)の使用が挙げられる。
本発明は、細胞培養状態から収集され、そして注入に適した媒体中で処方される、エキソビボ調製されたT細胞を包含する。処方の方法は、(1)細胞を、架橋の際に活性化シグナルを送達し得るT細胞表面成分に対して反応性を有する1つ以上の因子で標識する工程;(2)その標識された細胞を、生分解性のナノスフェアまたはマイクロスフェアと混合する工程であって、その生分解性のナノスフェアまたはマイクロスフェアは、そのT細胞表面成分に結合された因子を架橋し得る物質でコートされる、工程;(3)その標識化T細胞とコーティングされた生分解性架橋スフェアとの混合物を、注入に適した媒体中に懸濁させる工程;(4)その混合物を適切な容器(例えば、シリンジまたはIV注入バッグ)にパッケージングする工程;および(5)その混合物を患者に非経口投与する工程を包含する。
本発明の生分解性のスフェアは、好ましくは、ポリ(乳酸)(PLA)、ポリ(グリコール酸)(PGA)、PLAとPGAとのコポリマー(PLGA)またはポリ(カプロラクトン)(PCL)、およびポリ無水物のような、脂肪族ポリエステルから製造される。これらスフェアは、0.1〜500ミクロン、好ましくは10ミクロンより小さい、そして最も好ましくは1ミクロンより小さい粒子サイズに生成される。このサイズ範囲のマイクロスフェアは、従来方法によって身体中に直接注入し得る。コートされたスフェアが、生理学的流体中で7日以内、より好ましくは3日以内に分解するように設計されていることが好ましい。
Claims (12)
- 治療有効量の細胞を含む注入用組成物であって、該細胞の一部分がT細胞であって、該T細胞が、該T細胞の少なくとも一部分の細胞表面成分を結合する1つ以上の第一の因子に接触され、該1つ以上の第一の因子はマウス由来のモノクローナル抗体またはそのフラグメントもしくは遺伝子工学的に操作された誘導体であり、そして、該第一の因子が、生分解性の支持体に結合された第二の因子によって架橋され、該第二の因子は該第一の因子に対する特異性を有するヤギ抗マウスポリクローナル抗体であり、そして、該T細胞および生分解性の支持体が、非経口注入に適切な媒体中に懸濁され、そして適切な容器にパッケージングされ、該マウス由来モノクローナル抗体はマウス抗ヒトCD3 mAbおよびマウス抗ヒトCD28 mAbである、組成物。
- 前記容器が、折り畳み可能であり、可撓性材料からなる対向する壁、および該容器から突き出た可撓性チューブを備える、請求項1に記載の組成物。
- 前記容器がシリンジである、請求項1に記載の組成物。
- 治療有効量の細胞を含む注入用組成物を調製するための方法であって、該細胞の一部分がT細胞であり、該方法は、
該細胞を、架橋の際に活性化シグナルを送達し得るT細胞表面成分に対して反応性を有する1つ以上の第一の因子で標識する工程であって、該1つ以上の第一の因子は、マウス由来モノクローナル抗体またはそのフラグメントもしくは遺伝子工学的に操作された誘導体である、工程;
該標識された細胞を、生分解性のナノスフェアまたはマイクロスフェアと混合する工程であって、該生分解性のナノスフェアまたはマイクロスフェアは、該T細胞表面成分に結合された該第一の因子を架橋し得る第二の因子でコートされ、該第二の因子は該第一の因子に対する特異性を有するヤギ抗マウスポリクローナル抗体である、工程;
該標識されたT細胞とコートされた生分解性架橋スフェアとの混合物を、注入に適切な媒体中に懸濁させる工程;および
該混合物を適切な容器にパッケージングする工程
を包含し、該マウス由来モノクローナル抗体はマウス抗ヒトCD3 mAbおよびマウス抗ヒトCD28 mAbである、方法。 - 前記容器が、シリンジまたはIV注入バッグである、請求項4に記載の方法。
- 前記容器が、折り畳み可能である、請求項4に記載の方法。
- 前記容器が、可撓性材料からなる対向する壁および出口チューブを備える、請求項6に記載の方法。
- 治療有効量の細胞を含む注入用組成物を調製する方法であって、該細胞の一部分がT細胞であり、該方法は、
T細胞の集団を、1つ以上の第一の因子および第二の因子でコートされた生分解性のナノスフェアまたはマイクロスフェアと混合する工程であって、ここで、該第二の因子は、該第一の因子に架橋し、そして該第一の因子が、該T細胞上の表面成分に対して反応性を有し、該1つ以上の第一の因子はマウス由来のモノクローナル抗体またはそのフラグメントもしくは遺伝子工学的に操作された誘導体であり、そして該第二の因子は該第一の因子に対する特異性を有する特異性を有するヤギ抗マウスポリクローナル抗体であり、そしてここで、該第一の因子の該T細胞との相互作用が、該T細胞の活性化を引き起こす、工程;
該T細胞と該生分解性スフェアとの混合物を、注入に適切な媒体中に懸濁させる工程;および
該混合物を容器にパッケージングする工程
を包含し、該マウス由来モノクローナル抗体はマウス抗ヒトCD3 mAbおよびマウス抗ヒトCD28 mAbである、方法。 - 前記容器が、シリンジまたはIV注入バッグである、請求項8に記載の方法。
- 前記容器が、折り畳み可能である、請求項8に記載の方法。
- 前記容器が、可撓性材料からなる対向する壁および出口チューブを備える、請求項10に記載の方法。
- 前記パッケージ混合物のT細胞濃度が、1mlの注入媒体あたり少なくとも1×107細胞である、請求項8に記載の方法。
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US54903204P | 2004-03-01 | 2004-03-01 | |
US60/549,032 | 2004-03-01 | ||
PCT/US2005/006446 WO2005084276A2 (en) | 2004-03-01 | 2005-03-01 | Cell therapy formulation method and composition |
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CA (1) | CA2530514C (ja) |
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US20110142887A1 (en) * | 2009-12-15 | 2011-06-16 | Immunovative Therapies Ltd. | Methods and compositions for liquidation of tumors |
JP2007525225A (ja) | 2004-02-26 | 2007-09-06 | イミュノバティブ セラピーズ, リミテッド | 細胞治療のためのt細胞を調製するための方法 |
US7592431B2 (en) * | 2004-02-26 | 2009-09-22 | Immunovative Therapies, Ltd. | Biodegradable T-cell Activation device |
CA2838046C (en) | 2011-05-03 | 2023-03-07 | Immunovative Therapies, Ltd. | Induction of il-12 using immunotherapy |
CN108261423B (zh) | 2011-05-03 | 2021-01-08 | 免疫创新治疗有限公司 | 用于加工含有活细胞的生物药物的方法 |
SG11201605440TA (en) * | 2014-01-08 | 2016-08-30 | Immunovative Therapies Ltd | Treatment of human immunodeficiency virus/acquired immunodeficiency syndrome |
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US5766920A (en) | 1982-08-11 | 1998-06-16 | Cellcor, Inc. | Ex vivo activation of immune cells |
AU7873187A (en) | 1986-08-08 | 1988-02-24 | University Of Minnesota | Method of culturing leukocytes |
US6534055B1 (en) * | 1988-11-23 | 2003-03-18 | Genetics Institute, Inc. | Methods for selectively stimulating proliferation of T cells |
US6905680B2 (en) * | 1988-11-23 | 2005-06-14 | Genetics Institute, Inc. | Methods of treating HIV infected subjects |
US5126132A (en) | 1989-08-21 | 1992-06-30 | The United States Of America As Represented By The Department Of Health And Human Services | Tumor infiltrating lymphocytes as a treatment modality for human cancer |
US5728388A (en) | 1989-10-03 | 1998-03-17 | Terman; David S. | Method of cancer treatment |
CA2065658A1 (en) * | 1991-04-19 | 1992-10-20 | Tse-Wen Chang | Conjugates of liposomes or microbeads and antibodies specific for t lymphocytes and their use in vivo immune modulators |
AU5729294A (en) * | 1992-11-25 | 1994-06-22 | Tanox Biosystems, Inc. | Conjugates and constructs including anti-cd28 and anti-cd3 binding molecules |
PT700430E (pt) * | 1993-06-04 | 2005-07-29 | Univ Michigan | Processo para estimular selectivamente a proliferacao das celulas t |
SG49113A1 (en) | 1993-08-06 | 1998-05-18 | Cytel Corp | Methods for ex vivo therapy using peptide-loaded antigen presenting cells for the activation of ctl |
AU1333195A (en) * | 1994-06-03 | 1996-01-04 | Dana-Farber Cancer Institute | Methods for selectively stimulating proliferation of t cells |
US5827642A (en) | 1994-08-31 | 1998-10-27 | Fred Hutchinson Cancer Research Center | Rapid expansion method ("REM") for in vitro propagation of T lymphocytes |
EP0814838B1 (en) | 1995-03-08 | 2003-05-14 | The Scripps Research Institute | Antigen presenting system and activation of t-cells |
CA2278847A1 (en) | 1997-01-31 | 1998-08-06 | Hemosol Inc. | Method for the production of selected lymphocytes |
US20030119185A1 (en) * | 2000-02-24 | 2003-06-26 | Xcyte Therapies, Inc. | Activation and expansion of cells |
AU2002342299A1 (en) * | 2001-10-31 | 2003-05-12 | The Government Of The United States Of America, As Represented By The Secretary Of The Department Of | Generation of use of tc1 and tc2 cells |
AU2003202908A1 (en) * | 2002-01-03 | 2003-07-24 | The Trustees Of The University Of Pennsylvania | Activation and expansion of t-cells using an engineered multivalent signaling platform |
US7435592B2 (en) * | 2003-05-13 | 2008-10-14 | Immunovative Therapies, Ltd. | Compositions for allogeneic cell therapy |
JP2007525225A (ja) * | 2004-02-26 | 2007-09-06 | イミュノバティブ セラピーズ, リミテッド | 細胞治療のためのt細胞を調製するための方法 |
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HUE035726T2 (en) | 2018-05-28 |
IL173405A0 (en) | 2006-06-11 |
ES2635868T3 (es) | 2017-10-05 |
JP2014077018A (ja) | 2014-05-01 |
DK1749090T3 (en) | 2017-09-04 |
EP3202895A1 (en) | 2017-08-09 |
JP5649551B2 (ja) | 2015-01-07 |
WO2005084276A3 (en) | 2007-05-10 |
JP2007526314A (ja) | 2007-09-13 |
PT1749090T (pt) | 2017-08-28 |
EP1749090B1 (en) | 2017-05-17 |
EP1749090A4 (en) | 2009-04-29 |
EP1749090A2 (en) | 2007-02-07 |
IL210244A0 (en) | 2011-03-31 |
WO2005084276A2 (en) | 2005-09-15 |
IL223938B (en) | 2020-01-30 |
JP2012021033A (ja) | 2012-02-02 |
CA2530514C (en) | 2017-01-31 |
CA2530514A1 (en) | 2005-09-15 |
IL173405A (en) | 2011-02-28 |
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