JPWO2021032836A5 - - Google Patents
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上の実施形態の変形形態、更なる実施形態及びそれらの変形形態は、本開示を読むことによって当業者に明らかとなり、それら自体が本発明の範囲に含まれる。
本開示は、次の態様を包含する。
［項１］
ＴＣＲαβ
＋
Ｔ細胞の集団を生産する方法であって、
（ｉ）造血前駆細胞（ＨＰＣ）の集団を前駆Ｔ細胞に分化させることと、
（ｉｉ）前記前駆Ｔ細胞を成熟させて、ＴＣＲαβ
＋
Ｔ細胞の集団を生成することと、を含み、ここで、（ｉ）及び（ｉｉ）の一方又は両方を、誘導性共刺激因子リガンド（ＩＣＯＳ－Ｌ）の存在下で実施する、方法。
［項２］
ＩＣＯＳ－Ｌが存在すると、ＴＣＲαβ
＋
細胞に成熟するＨＰＣ又は前駆Ｔ細胞の割合が増加する、項１に記載の方法。
［項３］
前記ＨＰＣを、ＩＣＯＳ－Ｌの存在下で前駆Ｔ細胞に分化させる、項１又は２に記載の方法。
［項４］
前記前駆Ｔ細胞を、ＩＣＯＳ－Ｌの存在下で成熟させる、項１～３のいずれか一項に記載の方法。
［項５］
前記ＨＰＣ及び／又は前駆Ｔ細胞を、ＩＣＯＳ－Ｌで被覆された表面上で培養する、項１～４のいずれか一項に記載の方法。
［項６］
前記ＨＰＣは、ＣＤ３４
＋
表現型を有する、項１～５のいずれか一項に記載の方法。
［項７］
前記ＨＰＣの集団は、人工多能性幹細胞（ｉＰＳＣ）からｉｎ ｖｉｔｒｏで生成される、項１～６のいずれか一項に記載の方法。
［項８］
ｉＰＳＣの集団を準備することと、前記ｉＰＳＣをＨＰＣの集団に分化させることとを含む、項７に記載の方法。
［項９］
前記ｉＰＳＣは、ドナー個体から取得されたＴ細胞から誘導される、項７又は８に記載の方法。
［項１０］
前記ドナー個体から取得された前記Ｔ細胞は、標的抗原に特異的である、項９に記載の方法。
［項１１］
前記標的抗原は、腫瘍抗原である、項１０に記載の方法。
［項１２］
前記ドナー個体から取得された前記Ｔ細胞は、腫瘍浸潤リンパ球（ＴＩＬ）である、項１０又は１１に記載の方法。
［項１３］
リンパ球拡大培地中で前記ＨＰＣの集団を培養して、前記前駆Ｔ細胞を生成することを含む方法によって、前記ＨＰＣを分化させる、項１～１２のいずれか一項に記載の方法。
［項１４］
前記前駆Ｔ細胞は、ＣＤ５
＋
、ＣＤ７
＋
の表現型を有する、項１～１３のいずれか一項に記載の方法。
［項１５］
Ｔ細胞成熟培地中で前記前駆Ｔ細胞の集団を培養して、前記ＴＣＲαβ
＋
Ｔ細胞を生成することを含む方法によって、前記前駆Ｔ細胞を分化させる、項１～１４のいずれか一項に記載の方法。
［項１６］
前記ＴＣＲαβ
＋
Ｔ細胞は、ＣＤ８
＋
ＣＤ４
＋
表現型を有する、項１～１５のいずれか一項に記載の方法。
［項１７］
前記ＴＣＲαβ
＋
Ｔ細胞を活性化及び拡大させて、ＣＤ８
＋
単独陽性表現型又はＣＤ４
＋
単独陽性表現型を有するＴ細胞の集団を生成することを含む、項１～１６のいずれか一項に記載の方法。
［項１８］
前記ＴＣＲαβ
＋
Ｔ細胞は、標的抗原を発現する細胞に特異的に結合する、項１～１７のいずれか一項に記載の方法。
［項１９］
前記標的抗原は、腫瘍抗原である、項１８に記載の方法。
［項２０］
前記ＴＣＲαβ
＋
Ｔ細胞は、前記腫瘍抗原を発現する癌細胞に特異的に結合する、項１９に記載の方法。
［項２１］
αβＴＣＲをコードする異種核酸を、前記ｉＰＳＣ、前記ＨＰＣ、又は前記前駆Ｔ細胞に導入することを更に含む、項１～２０のいずれか一項に記載の方法。
［項２２］
前記αβＴＣＲをコードする前記異種核酸は、発現ベクター中に含まれている、項２１に記載の方法。
［項２３］
前記発現ベクターは、レンチウイルスベクターである、項２２に記載の方法。
［項２４］
前記αβＴＣＲは、親和性増強ＴＣＲである、項２１～２３のいずれか一項に記載の方法。
［項２５］
前記αβＴＣＲは、細胞によって発現される標的抗原のペプチド断片を提示するＭＨＣに特異的に結合する、又はＭＨＣ提示とは無関係に細胞によって発現される標的抗原若しくはそのペプチドに特異的に結合する、項２１～２４のいずれか一項に記載の方法。
［項２６］
前記αβＴＣＲは、癌細胞によって発現される腫瘍抗原のペプチド断片を提示するＭＨＣに特異的に結合する、又はＭＨＣ提示とは無関係に癌細胞によって発現される腫瘍抗原若しくはそのペプチド断片に特異的に結合する、項２５に記載の方法。
［項２７］
前記ＴＣＲαβ
＋
Ｔ細胞を分離又は精製することを更に含む、項１～２６のいずれか一項に記載の方法。
［項２８］
ＴＣＲαβ
＋
Ｔ細胞を、磁気活性化セルソーティングによって分離する、項２７に記載の方法。
［項２９］
前記ＴＣＲαβ
＋
Ｔ細胞の集団を濃縮することを含む、項１～２８のいずれか一項に記載の方法。
［項３０］
前記ＴＣＲαβ
＋
Ｔ細胞の集団を貯蔵することを含む、項１～２９のいずれか一項に記載の方法。
［項３１］
前記ＴＣＲαβ
＋
Ｔ細胞の集団を薬学的に許容可能な添加剤とともに製剤化することを含む、項１～３０のいずれか一項に記載の方法。
［項３２］
項１～３１のいずれか一項に記載の方法によって生産されるＴＣＲαβ
＋
Ｔ細胞の集団。
［項３３］
項１～３１のいずれか一項に記載の方法によって生産されるＴＣＲαβ
＋
Ｔ細胞の集団と、薬学的に許容可能な添加剤とを含む医薬組成物。
［項３４］
治療方法において使用するための、項１～３１のいずれか一項に記載の方法によって生産されるＴＣＲαβ
＋
Ｔ細胞の集団。
［項３５］
癌の治療方法において使用するための、項１～３１のいずれか一項に記載の方法によって生産されるＴＣＲαβ
＋
Ｔ細胞の集団。
［項３６］
ＩＣＯＳ－Ｌを含む、細胞培養容器の表面を処理するための被覆組成物。
［項３７］
Ｎｏｔｃｈシグナル伝達リガンドを更に含む、項３６に記載の組成物。
［項３８］
ＩＣＯＳ－Ｌで被覆された表面を含む、Ｔ細胞培養用の培養容器。
［項３９］
前記表面は、Ｎｏｔｃｈシグナル伝達リガンドで更に被覆されている、項３９に記載の培養容器。
Variations of the above embodiments, further embodiments and variations thereof will become apparent to those of ordinary skill in the art upon reading this disclosure and as such are within the scope of the invention.
The present disclosure includes the following aspects.
[Section 1]
A method of producing a population of TCRαβ + T cells comprising:
(i) differentiating a population of hematopoietic progenitor cells (HPCs) into progenitor T cells;
(ii) maturing said progenitor T cells to generate a population of TCRαβ + T cells, wherein one or both of (i) and (ii) are combined with an inducible costimulator ligand ( ICOS-L).
[Section 2]
2. The method of paragraph 1, wherein the presence of ICOS-L increases the proportion of HPCs or progenitor T cells that mature into TCRαβ + cells.
[Section 3]
Item 3. The method of Item 1 or 2, wherein the HPCs are differentiated into progenitor T cells in the presence of ICOS-L.
[Section 4]
Clause 4. The method of any one of clauses 1-3, wherein said progenitor T cells are matured in the presence of ICOS-L.
[Section 5]
5. The method of any one of paragraphs 1-4, wherein the HPCs and/or progenitor T cells are cultured on a surface coated with ICOS-L.
[Section 6]
Clause 6. The method of any one of clauses 1-5, wherein said HPC has a CD34 + phenotype.
[Section 7]
Clause 7. The method of any one of clauses 1-6, wherein the population of HPCs is generated in vitro from induced pluripotent stem cells (iPSCs).
[Item 8]
8. The method of paragraph 7, comprising providing a population of iPSCs and differentiating said iPSCs into a population of HPCs.
[Item 9]
Item 9. The method of Item 7 or 8, wherein the iPSCs are derived from T cells obtained from a donor individual.
[Item 10]
10. The method of paragraph 9, wherein said T cells obtained from said donor individual are specific for a target antigen.
[Item 11]
11. The method of Paragraph 10, wherein the target antigen is a tumor antigen.
[Item 12]
12. The method of paragraph 10 or 11, wherein said T cells obtained from said donor individual are tumor infiltrating lymphocytes (TIL).
[Item 13]
13. The method of any one of paragraphs 1-12, wherein the HPCs are differentiated by a method comprising culturing the population of HPCs in lymphocyte expansion medium to generate the progenitor T cells.
[Item 14]
14. The method of any one of paragraphs 1-13, wherein said progenitor T cells have a CD5 + , CD7 + phenotype.
[Item 15]
15. The method of any one of paragraphs 1-14, wherein the progenitor T cells are differentiated by a method comprising culturing the population of progenitor T cells in a T cell maturation medium to generate the TCRαβ + T cells. the method of.
[Item 16]
Clause 16. The method of any one of clauses 1-15, wherein said TCRαβ + T cells have a CD8 + CD4 + phenotype.
[Item 17]
17. Any one of paragraphs 1 to 16 , comprising activating and expanding said TCRαβ + T cells to generate a population of T cells with a CD8 + single positive phenotype or a CD4 + single positive phenotype. the method of.
[Item 18]
18. The method of any one of paragraphs 1-17, wherein said TCRαβ + T cells specifically bind to cells expressing a target antigen.
[Item 19]
19. The method of Paragraph 18, wherein said target antigen is a tumor antigen.
[Section 20]
20. The method of Paragraph 19, wherein said TCRαβ + T cells specifically bind to cancer cells expressing said tumor antigen.
[Section 21]
21. The method of any one of paragraphs 1-20, further comprising introducing a heterologous nucleic acid encoding an αβTCR into said iPSC, said HPC, or said progenitor T cell.
[Section 22]
22. The method of Paragraph 21, wherein said heterologous nucleic acid encoding said αβTCR is contained in an expression vector.
[Section 23]
23. The method of Paragraph 22, wherein said expression vector is a lentiviral vector.
[Section 24]
24. The method of any one of paragraphs 21-23, wherein said αβTCR is an affinity-enhanced TCR.
[Section 25]
wherein said αβTCR specifically binds to MHC presenting a peptide fragment of the target antigen expressed by the cell, or specifically binds to the target antigen or its peptide expressed by the cell independently of MHC presentation, 25. The method according to any one of 21-24.
[Section 26]
The αβTCR specifically binds to MHC presenting peptide fragments of tumor antigens expressed by cancer cells, or specifically binds to tumor antigens or peptide fragments thereof expressed by cancer cells independently of MHC presentation. 26. The method of paragraph 25, wherein
[Section 27]
27. The method of any one of paragraphs 1-26, further comprising isolating or purifying said TCRαβ + T cells.
[Section 28]
28. The method of Paragraph 27, wherein TCRαβ + T cells are separated by magnetic-activated cell sorting.
[Section 29]
29. The method of any one of paragraphs 1-28, comprising enriching the population of TCRαβ + T cells.
[Item 30]
30. The method of any one of paragraphs 1-29, comprising storing the population of TCRαβ + T cells.
[Item 31]
31. The method of any one of paragraphs 1-30, comprising formulating said population of TCRαβ + T cells with a pharmaceutically acceptable excipient .
[Item 32]
32. A population of TCRαβ + T cells produced by the method of any one of Items 1-31 .
[Item 33]
A pharmaceutical composition comprising a population of TCRαβ + T cells produced by the method according to any one of Items 1 to 31 and a pharmaceutically acceptable excipient.
[Item 34]
32. A population of TCRαβ + T cells produced by the method of any one of paragraphs 1-31 for use in a method of treatment.
[Item 35]
32. A population of TCRαβ + T cells produced by the method of any one of paragraphs 1-31 for use in a method of treating cancer.
[Item 36]
A coating composition for treating the surface of a cell culture vessel, comprising ICOS-L.
[Item 37]
37. The composition of Paragraph 36, further comprising a Notch signaling ligand.
[Item 38]
A culture vessel for culturing T cells comprising a surface coated with ICOS-L.
[Item 39]
40. The culture vessel of Paragraph 39, wherein said surface is further coated with a Notch signaling ligand.
Claims (15)
（ｉ）造血前駆細胞（ＨＰＣ）の集団を前駆Ｔ細胞に分化させることと、
（ｉｉ）前記前駆Ｔ細胞を成熟させて、ＴＣＲαβ＋Ｔ細胞の集団を生成することと、を含み、ここで、（ｉ）及び（ｉｉ）の一方又は両方を、誘導性共刺激因子リガンド（ＩＣＯＳ－Ｌ）の存在下で実施する、方法。 A method of producing a population of TCRαβ + T cells comprising:
(i) differentiating a population of hematopoietic progenitor cells (HPCs) into progenitor T cells;
(ii) maturing said progenitor T cells to generate a population of TCRαβ + T cells, wherein one or both of (i) and (ii) are combined with an inducible costimulator ligand ( ICOS-L).
（ｉｉ）前記ＨＰＣをＩＣＯＳ－Ｌの存在下で前駆Ｔ細胞に分化させる、及び／又は
（ｉｉｉ）前記前駆Ｔ細胞をＩＣＯＳ－Ｌの存在下で成熟させる、請求項１に記載の方法。 (i) the presence of ICOS-L increases the proportion of HPCs or progenitor T cells that mature into TCRαβ + cells, and/or
(ii) differentiating said HPCs into progenitor T cells in the presence of ICOS-L, and/or
(iii) maturing said progenitor T cells in the presence of ICOS-L .
（ｉｉ）前記ＨＰＣの集団は、人工多能性幹細胞（ｉＰＳＣ）からｉｎ ｖｉｔｒｏで生成され、前記方法は、ｉＰＳＣの集団を準備することと、前記ｉＰＳＣをＨＰＣの集団に分化させることとを含んでいてもよい、請求項１～３のいずれか一項に記載の方法。 (i) said HPC has a CD34 + phenotype, and/or
(ii) said population of HPCs is generated in vitro from induced pluripotent stem cells (iPSCs), said method comprising providing a population of iPSCs and differentiating said iPSCs into a population of HPCs; The method according to any one of claims 1 to 3 , which may be
（ｉ）前記標的抗原は、腫瘍抗原であること、
（ｉｉ）前記ドナー個体から取得された前記Ｔ細胞は、腫瘍浸潤リンパ球（ＴＩＬ）であること。 The iPSCs may be induced from T cells obtained from a donor individual, and the T cells obtained from the donor individual may be specific for a target antigen, and further (i) and / or (ii) below 5. The method of claim 4 , which may be satisfied .
(i) the target antigen is a tumor antigen;
(ii) said T cells obtained from said donor individual are tumor infiltrating lymphocytes (TIL);
（ｉｉ）Ｔ細胞成熟培地中で前記前駆Ｔ細胞の集団を培養して、前記ＴＣＲαβ ＋ Ｔ細胞を生成することを含む方法によって、前記前駆Ｔ細胞を分化させる、請求項１～６のいずれか一項に記載の方法。 (i) said progenitor T cells have a CD5 + , CD7 + phenotype, and/or
(ii) differentiating said progenitor T cells by a method comprising culturing said population of progenitor T cells in a T cell maturation medium to generate said TCRαβ + T cells. The method according to item 1.
（ｉｉ）前記方法は、前記ＴＣＲαβ ＋ Ｔ細胞を活性化及び拡大させて、ＣＤ８ ＋ 単独陽性表現型又はＣＤ４ ＋ 単独陽性表現型を有するＴ細胞の集団を生成することを含む、請求項１～７のいずれか一項に記載の方法。 (i) said TCRαβ + T cells have a CD8 + CD4 + phenotype, and/or
(ii) said method comprises activating and expanding said TCRαβ + T cells to generate a population of T cells with a CD8 + single-positive phenotype or a CD4 + single-positive phenotype; 8. The method of any one of 7 .
前記αβＴＣＲをコードする前記異種核酸は、発現ベクター中に含まれていてもよく、前記発現ベクターはレンチウイルスベクターであってもよい、請求項１～９のいずれか一項に記載の方法。 said method further comprising introducing a heterologous nucleic acid encoding an αβTCR into said iPSC, said HPC, or said progenitor T cell;
The method according to any one of claims 1 to 9 , wherein said heterologous nucleic acid encoding said αβTCR may be contained in an expression vector, and said expression vector may be a lentiviral vector.
前記αβＴＣＲは、細胞によって発現される標的抗原のペプチド断片を提示するＭＨＣに特異的に結合してもよく、又はＭＨＣ提示とは無関係に細胞によって発現される標的抗原若しくはそのペプチドに特異的に結合してもよく、
更に、前記αβＴＣＲは、癌細胞によって発現される腫瘍抗原のペプチド断片を提示するＭＨＣに特異的に結合してもよく、又はＭＨＣ提示とは無関係に癌細胞によって発現される腫瘍抗原若しくはそのペプチド断片に特異的に結合してもよい、請求項１０に記載の方法。 said αβTCR is an affinity-enhancing TCR,
Said αβTCR may specifically bind to MHC presenting a peptide fragment of the target antigen expressed by the cell, or specifically bind to the target antigen or its peptides expressed by the cell independently of MHC presentation. You may
Furthermore, said αβTCR may specifically bind to MHC presenting peptide fragments of tumor antigens expressed by cancer cells, or tumor antigens or peptide fragments thereof expressed by cancer cells independently of MHC presentation. 11. The method of claim 10 , which may specifically bind to
（ｉ）ＴＣＲαβ ＋ Ｔ細胞を磁気活性化セルソーティングによって分離すること、
（ｉｉ）前記方法は、前記ＴＣＲαβ ＋ Ｔ細胞の集団を濃縮することを更に含むこと、
（ｉｉｉ）前記方法は、前記ＴＣＲαβ ＋ Ｔ細胞の集団を貯蔵することを更に含むこと。 The method according to any one of claims 1 to 11 , further comprising isolating or purifying the TCRαβ + T cells , and optionally satisfying (i) and/or (ii) and/or (iii) below. described method.
(i) separating TCRαβ + T cells by magnetic-activated cell sorting;
(ii) the method further comprises enriching the population of TCRαβ + T cells;
(iii) said method further comprising storing said population of TCRαβ + T cells;
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB1911958.5A GB201911958D0 (en) | 2019-08-20 | 2019-08-20 | Methods of t cell production |
| GB1911958.5 | 2019-08-20 | ||
| PCT/EP2020/073332 WO2021032836A1 (en) | 2019-08-20 | 2020-08-20 | Methods of t cell production |
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| JP2022545416A JP2022545416A (en) | 2022-10-27 |
| JPWO2021032836A5 true JPWO2021032836A5 (en) | 2023-08-18 |
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| US (1) | US20220267729A1 (en) |
| EP (1) | EP4017966A1 (en) |
| JP (1) | JP2022545416A (en) |
| KR (1) | KR20220047376A (en) |
| CN (1) | CN114364790A (en) |
| AU (1) | AU2020332059A1 (en) |
| CA (1) | CA3150425A1 (en) |
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| GB202205572D0 (en) | 2022-04-14 | 2022-06-01 | Adaptimmune Ltd | Engineered T cells |
| GB202208545D0 (en) | 2022-06-10 | 2022-07-27 | Adaptimmune Ltd | Production of immune cells |
| WO2024077158A1 (en) * | 2022-10-05 | 2024-04-11 | Garuda Therapeutics, Inc. | Pluripotent stem cell-derived t cell populations and progenitors thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7575925B2 (en) * | 2002-12-10 | 2009-08-18 | Sunnybrook Health Sciences Centre | Cell preparations comprising cells of the T cell lineage and methods of making and using them |
| WO2011097477A1 (en) * | 2010-02-04 | 2011-08-11 | The Trustees Of The University Of Pennsylvania | Icos critically regulates the expansion and function of inflammatory human th17 cells |
| US11154573B2 (en) * | 2015-10-30 | 2021-10-26 | The Regents Of The University Of California | Methods of generating T-cells from stem cells and immunotherapeutic methods using the T-cells |
| GB201616238D0 (en) * | 2016-09-23 | 2016-11-09 | Adaptimmune Ltd | Modified T cells |
| CN110199017A (en) * | 2017-01-20 | 2019-09-03 | 国立大学法人京都大学 | CD8 alpha+beta+cytotoxic T cell preparation method |
| WO2018167486A1 (en) * | 2017-03-15 | 2018-09-20 | Oxford Biomedica (Uk) Limited | Method |
| EP3601573A4 (en) * | 2017-03-29 | 2020-12-23 | Sunnybrook Research Institute | Engineered t-cell modulating molecules and methods of using same |
| US20200179451A1 (en) * | 2017-07-19 | 2020-06-11 | Fate Therapeutics, Inc. | Compositions and methods for immune cell modulation in adoptive immunotherapies |
| GB202102297D0 (en) * | 2021-02-18 | 2021-04-07 | Adaptimmune Ltd | Methods of Producing Haemogenic Endothelial Cells from Pluripotent Stem Cells |
-
2019
- 2019-08-20 GB GBGB1911958.5A patent/GB201911958D0/en not_active Ceased
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2020
- 2020-08-20 WO PCT/EP2020/073332 patent/WO2021032836A1/en unknown
- 2020-08-20 JP JP2022510804A patent/JP2022545416A/en active Pending
- 2020-08-20 KR KR1020227009208A patent/KR20220047376A/en unknown
- 2020-08-20 AU AU2020332059A patent/AU2020332059A1/en active Pending
- 2020-08-20 US US17/630,884 patent/US20220267729A1/en active Pending
- 2020-08-20 CN CN202080059142.9A patent/CN114364790A/en active Pending
- 2020-08-20 CA CA3150425A patent/CA3150425A1/en active Pending
- 2020-08-20 EP EP20761182.3A patent/EP4017966A1/en active Pending
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