JPWO2019220109A5 - - Google Patents
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- JPWO2019220109A5 JPWO2019220109A5 JP2020564248A JP2020564248A JPWO2019220109A5 JP WO2019220109 A5 JPWO2019220109 A5 JP WO2019220109A5 JP 2020564248 A JP2020564248 A JP 2020564248A JP 2020564248 A JP2020564248 A JP 2020564248A JP WO2019220109 A5 JPWO2019220109 A5 JP WO2019220109A5
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Description
したがって、大きいか嵩高い標的抗原を発現する標的細胞を死滅させることができる代替のCAR T細胞アプローチが必要である。
特定の実施形態では、例えば、以下が提供される:
(項目1)
嵩高い細胞外ドメインを有する標的抗原に結合するキメラ抗原受容体(CAR)であって、前記CARがFab抗原結合ドメインを含む、キメラ抗原受容体(CAR)。
(項目2)
前記標的抗原が、少なくとも約150Åの細胞外ドメインを有する、項目1に記載のCAR。
(項目3)
前記標的抗原が、少なくとも約400個のアミノ酸の細胞外ドメインを有する、項目1または2に記載のCAR。
(項目4)
前記標的抗原が、CD22、CD21、CEACAM5、MUC1、またはFcRL5である、前記項目のいずれかに記載のCAR。
(項目5)
前記標的抗原がCD22である、項目4に記載のCAR。
(項目6)
前記抗原結合ドメインが、
a)以下の配列を有する相補性決定領域(CDR)を有する重鎖可変領域(VH)
b)以下の配列を有する相補性決定領域(CDR)を有する軽鎖可変領域(VL):
(項目7)
配列番号65として示した配列を有するVHドメイン;および配列番号66として示した配列を有するVLドメインを含む、項目6に記載のCAR。
(項目8)
前記抗原結合ドメインが、a)以下の配列を有する相補性決定領域(CDR)を有する重鎖可変領域(VH):
b)以下の配列を有する相補性決定領域(CDR)を有する軽鎖可変領域(VL):
(項目9)
配列番号99として示した配列を有するVHドメイン;および配列番号100として示した配列を有するVLドメインを含む、項目6に記載のCAR。
(項目10)
前記項目のいずれかに記載のCARをコードする核酸配列。
(項目11)
以下の一般構造:
VH-CH-spacer-TM-endo-coexpr-VL-CL
を有し、
ここで、
VHは、第1のポリペプチドの重鎖可変ドメインをコードする核酸配列であり;
CHは、前記第1のポリペプチドの重鎖定常ドメインをコードする核酸配列であり;
spacerは、前記第1のポリペプチドのスペーサーをコードする核酸配列であり;
TMは、前記第1のポリペプチドの膜貫通領域をコードする核酸配列であり;
endoは、前記第1のポリペプチドのエンドドメインをコードする核酸配列であり;
VLは、第2のポリペプチドの軽鎖可変ドメインをコードする核酸配列であり;
CLは、前記第2のポリペプチドの軽鎖定常ドメインをコードする核酸配列であり;
coexprは、前記第1および第2のポリペプチドの共発現が可能な核酸配列である、項目10に記載の核酸配列。
(項目12)
項目10または11に記載の第1の核酸配列、およびドメイン抗体(dAb)抗原結合ドメインまたはscFv抗原結合ドメインを有する第2のキメラ抗原受容体をコードする第2の核酸配列を含む、核酸構築物。
(項目13)
項目10または11に記載の第1の核酸配列;ドメイン抗体(dAb)抗原結合ドメインを有する第2のキメラ抗原受容体をコードする第2の核酸配列;およびscFv抗原結合ドメインを有する第3のCARをコードする第3の核酸配列を含む、核酸構築物。
(項目14)
前記第1の核酸配列が抗CD22 Fab CARをコードし;前記第2の核酸配列が抗CD79 dAb CARをコードし;前記第3の核酸配列が抗CD19 scFv CARをコードする、項目13に記載の核酸構築物。
(項目15)
項目10または11に記載の核酸配列または項目12~14のいずれかに記載の核酸構築物を含む、ベクター。
(項目16)
項目1~9のいずれかに記載のCARを発現する細胞。
(項目17)
項目1~9のいずれかに記載の第1のCAR、およびドメイン抗体(dAb)抗原結合ドメインまたはscFv抗原結合ドメインを有する第2のキメラ抗原受容体を発現する細胞。
(項目18)
項目1~9のいずれかに記載の第1のCAR、およびドメイン抗体(dAb)抗原結合ドメインを有する第2のCAR;およびscFv抗原結合ドメインを有する第3のCARを発現する細胞。
(項目19)
前記第1のCARが抗CD22 Fab CARであり;前記第2のCARが抗CD79 dAb CARであり;前記第3のCARが抗CD19 scFv CARである、項目16に記載の細胞。
(項目20)
項目10または11に記載の核酸配列;項目12~14のいずれかに記載の核酸構築物;または項目15に記載のベクターを細胞にex vivoで導入するステップを含む、項目16~19のいずれかに記載の細胞を作製する方法。
(項目21)
項目16~19のいずれかに記載の細胞の複数を、薬学的に許容され得る担体、希釈剤、または賦形剤と共に含む、医薬組成物。
(項目22)
項目19に記載の医薬組成物を被験体に投与するステップを含む、がんを処置する方法。
(項目23)
前記がんがB細胞リンパ腫または白血病である、項目22に記載の方法。
(項目24)
がんの処置で使用するための項目21に記載の医薬組成物。
(項目25)
がんを処置するための医薬組成物の製造における項目16~19のいずれかに記載の細胞の使用。
Therefore, there is a need for an alternative CAR T cell approach that can kill target cells that express large or bulky target antigens.
In certain embodiments, for example, the following are provided:
(Item 1)
A chimeric antigen receptor (CAR) that binds to a target antigen having a bulky extracellular domain, wherein the CAR comprises a Fab antigen binding domain.
(Item 2)
The CAR according to item 1, wherein the target antigen has an extracellular domain of at least about 150 Å.
(Item 3)
The CAR according to item 1 or 2, wherein the target antigen has an extracellular domain of at least about 400 amino acids.
(Item 4)
The CAR according to any one of the above items, wherein the target antigen is CD22, CD21, CEACAM5, MUC1, or FcRL5.
(Item 5)
The CAR according to item 4, wherein the target antigen is CD22.
(Item 6)
The antigen-binding domain is
a) Heavy chain variable regions (VHs) with complementarity determining regions (CDRs) having the following sequences
b) Light chain variable regions (VL) with complementarity determining regions (CDRs) having the following sequences:
(Item 7)
6. The CAR of item 6, comprising a VH domain having the sequence shown as SEQ ID NO: 65; and a VL domain having the sequence shown as SEQ ID NO: 66.
(Item 8)
The heavy chain variable region (VH) in which the antigen-binding domain has complementarity determining regions (CDRs) having the following sequences a):
b) Light chain variable regions (VL) with complementarity determining regions (CDRs) having the following sequences:
(Item 9)
6. The CAR of item 6, comprising a VH domain having the sequence shown as SEQ ID NO: 99; and a VL domain having the sequence shown as SEQ ID NO: 100.
(Item 10)
The nucleic acid sequence encoding the CAR according to any of the above items.
(Item 11)
The following general structure:
VH-CH-spacer-TM-endo-coexpr-VL-CL
Have,
here,
VH is a nucleic acid sequence encoding the heavy chain variable domain of the first polypeptide;
CH is a nucleic acid sequence encoding the heavy chain constant domain of the first polypeptide;
The spacer is a nucleic acid sequence encoding the spacer of the first polypeptide;
TM is a nucleic acid sequence encoding the transmembrane domain of the first polypeptide;
endo is a nucleic acid sequence encoding the end domain of the first polypeptide;
VL is a nucleic acid sequence encoding the light chain variable domain of the second polypeptide;
CL is a nucleic acid sequence encoding the light chain constant domain of the second polypeptide;
The nucleic acid sequence according to item 10, wherein coexpr is a nucleic acid sequence capable of co-expressing the first and second polypeptides.
(Item 12)
A nucleic acid construct comprising a first nucleic acid sequence according to item 10 or 11 and a second nucleic acid sequence encoding a second chimeric antigen receptor having a domain antibody (dAb) antigen binding domain or scFv antigen binding domain.
(Item 13)
The first nucleic acid sequence according to item 10 or 11; a second nucleic acid sequence encoding a second chimeric antigen-binding receptor having a domain antibody (dAb) antigen-binding domain; and a third CAR having a scFv antigen-binding domain. A nucleic acid construct comprising a third nucleic acid sequence encoding.
(Item 14)
13. The third nucleic acid sequence encodes anti-CD19 scFv CAR; the first nucleic acid sequence encodes anti-CD22 Fab CAR; the second nucleic acid sequence encodes anti-CD79 dAb CAR; the third nucleic acid sequence encodes anti-CD19 scFv CAR, item 13. Nucleic acid construct.
(Item 15)
A vector comprising the nucleic acid sequence according to item 10 or 11 or the nucleic acid construct according to any one of items 12-14.
(Item 16)
A cell expressing CAR according to any one of items 1 to 9.
(Item 17)
A cell expressing a first CAR according to any one of items 1 to 9, and a second chimeric antigen receptor having a domain antibody (dAb) antigen-binding domain or scFv antigen-binding domain.
(Item 18)
A cell expressing a first CAR according to any one of items 1 to 9, a second CAR having a domain antibody (dAb) antigen binding domain; and a third CAR having a scFv antigen binding domain.
(Item 19)
16. The cell of item 16, wherein the first CAR is an anti-CD22 Fab CAR; the second CAR is an anti-CD79 dAb CAR; the third CAR is an anti-CD19 scFv CAR.
(Item 20)
Item 16-19, comprising the step of ex vivo introducing the nucleic acid sequence of item 10 or 11; the nucleic acid construct of any of items 12-14; or the vector of item 15 into cells ex vivo. The method for producing the described cells.
(Item 21)
A pharmaceutical composition comprising a plurality of cells according to any one of items 16 to 19 together with a pharmaceutically acceptable carrier, diluent, or excipient.
(Item 22)
A method of treating cancer, comprising the step of administering the pharmaceutical composition of item 19 to a subject.
(Item 23)
22. The method of item 22, wherein the cancer is B-cell lymphoma or leukemia.
(Item 24)
21. The pharmaceutical composition according to item 21 for use in the treatment of cancer.
(Item 25)
Use of the cells according to any of items 16-19 in the manufacture of a pharmaceutical composition for treating cancer.
Claims (30)
a)以下の配列: a) The following sequence:
b)以下の配列: b) The following sequence:
を含む、抗原結合ドメイン。Antigen binding domain, including.
a)以下の配列: a) The following sequence:
b)以下の配列: b) The following sequence:
を含む、請求項12に記載の核酸構築物。12. The nucleic acid construct according to claim 12.
VH-CH-spacer1-TM1-endo1-coexpr1-VL-CL-coexpr2-AgBD-spacer2-TM2-endo2; VH-CH-spacer1-TM1-endo1-coexpr1-VL-CL-coexpr2-AgBD-spacer2-TM2-endo2;
VL-CL-spacer-TM1-endo1-coexpr1-VH-CH-coexpr2-AgBD-spacer2-TM2-endo2; VL-CL-sperer-TM1-endo1-coexpr1-VH-CH-coexpr2-AgBD-scaper2-TM2-endo2;
AgBD-spacer2-TM2-endo2-VH-CH-spacer1-TM1-endo1-coexpr2-VL-CL; AgBD-spacer2-TM2-endo2-VH-CH-spacer1-TM1-endo1-coexpr2-VL-CL;
AgBD-spacer2-TM2-endo2-coexpr1-VL-CL-spacer-TM1-endo1-coexpr2-VH-CH AgBD-spacer2-TM2-endo2-coexpr1-VL-CL-scaper-TM1-endo1-coexpr2-VH-CH
VL-CL-coexpr1-VH-CH-spacer1-TM1-endo1--coexpr2-AgBD-spacer2-TM2-endo2; VL-CL-coexpr1-VH-CH-scaper1-TM1-endo1-coexpr2-AgBD-spacer2-TM2-endo2;
VH-CH-coexpr1-VL-CL-spacer-TM1-endo1-coexpr2-AgBD-spacer2-TM2-endo2; VH-CH-coexpr1-VL-CL-scaper-TM1-endo1-coexpr2-AgBD-spacer2-TM2-endo2;
AgBD-spacer2-TM2-endo2-VL-CL-coexpr2-VH-CH-spacer1-TM1-endo1;または AgBD-spacer2-TM2-endo2-VL-CL-coexpr2-VH-CH-scaper1-TM1-endo1; or
AgBD-spacer2-TM2-endo2-coexpr1-VH-CH-coexpr2-VL-CL-spacer-TM1-endo1 AgBD-spacer2-TM2-endo2-coexpr1-VH-CH-coexpr2-VL-CL-scaper-TM1-endo1
を有し、ここで、Have, here,
VHは、前記第1のCARの重鎖可変領域をコードする核酸配列であり; VH is a nucleic acid sequence encoding the heavy chain variable region of the first CAR;
CHは、前記第1のCARの重鎖定常領域をコードする核酸配列であり; CH is a nucleic acid sequence encoding the heavy chain constant region of the first CAR;
spacer1は、前記第1のCARのスペーサーをコードする核酸配列であり; spacer1 is a nucleic acid sequence encoding the spacer of the first CAR;
TM1は、前記第1のCARの膜貫通ドメインをコードする核酸配列であり; TM1 is a nucleic acid sequence encoding the transmembrane domain of the first CAR;
endo1は、前記第1のCARのエンドドメインをコードする核酸配列であり; endo1 is a nucleic acid sequence encoding the end domain of the first CAR;
coexpr1およびcoexpr2は、同一でも異なっていてもよく、前記第1のCAR;および前記第2のCARの前記第1および第2のポリペプチドの共発現が可能な核酸配列であり; coexpr1 and coexpr2 may be the same or different, and are nucleic acid sequences capable of co-expressing the first and second polypeptides of the first CAR; and the second CAR;
VLは、前記第1のCARの軽鎖可変領域をコードする核酸配列であり; VL is a nucleic acid sequence encoding the light chain variable region of the first CAR;
CLは、前記第1のCARの軽鎖定常領域をコードする核酸配列であり; CL is a nucleic acid sequence encoding the light chain constant region of the first CAR;
AgBDは、前記第2のCARの抗原結合ドメインをコードする核酸配列であり; AgBD is a nucleic acid sequence encoding the antigen-binding domain of the second CAR;
spacer2は、前記第2のCARのスペーサーをコードする核酸配列であり; spacer2 is a nucleic acid sequence encoding the spacer of the second CAR;
TM2は、前記第2のCARの膜貫通ドメインをコードする核酸配列であり; TM2 is a nucleic acid sequence encoding the transmembrane domain of the second CAR;
endo2は、前記第2のCARのエンドドメインをコードする核酸配列である、核酸構築物。 endo2 is a nucleic acid construct which is a nucleic acid sequence encoding the end domain of the second CAR.
AgBD1-spacer1-TM1-endo1-coexpr-AgBD2-spacer2-TM2-endo2;または AgBD1-scaper1-TM1-endo1-coexpr-AgBD2-scaper2-TM2-endo2; or
AgBD2-spacer2-TM2-endo2-coexpr-AgBD1-spacer1-TM1-endo1 AgBD2-scaper2-TM2-endo2-coexpr-AgBD1-scaper1-TM1-endo1
を有し、ここで、Have, here,
AgBD1は、前記第1のCARの抗原結合ドメインをコードする核酸配列であり; AgBD1 is a nucleic acid sequence encoding the antigen-binding domain of the first CAR;
spacer1は、前記第1のCARのスペーサーをコードする核酸配列であり; spacer1 is a nucleic acid sequence encoding the spacer of the first CAR;
TM1は、前記第1のCARの膜貫通ドメインをコードする核酸配列であり; TM1 is a nucleic acid sequence encoding the transmembrane domain of the first CAR;
endo1は、前記第1のCARのエンドドメインをコードする核酸配列であり、 endo1 is a nucleic acid sequence encoding the end domain of the first CAR.
coexprは、前記第1および第2のCARの共発現が可能な核酸配列であり; coexpr is a nucleic acid sequence capable of co-expressing the first and second CARs;
AgBD2は、前記第2のCARの抗原結合ドメインをコードする核酸配列であり; AgBD2 is a nucleic acid sequence encoding the antigen-binding domain of the second CAR;
spacer2は、前記第2のCARのスペーサーをコードする核酸配列であり; spacer2 is a nucleic acid sequence encoding the spacer of the second CAR;
TM2は、前記第2のCARの膜貫通ドメインをコードする核酸配列であり; TM2 is a nucleic acid sequence encoding the transmembrane domain of the second CAR;
endo2は、前記第2のCARのエンドドメインをコードする核酸配列である、核酸構築物。 endo2 is a nucleic acid construct which is a nucleic acid sequence encoding the end domain of the second CAR.
a)以下の配列: a) The following sequence:
b)以下の配列: b) The following sequence:
を含む、請求項22に記載の細胞。22. The cell according to claim 22.
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JP2023064079A JP2023080185A (en) | 2018-05-15 | 2023-04-11 | chimeric antigen receptor |
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GB1807866.7 | 2018-05-15 | ||
GBGB1807866.7A GB201807866D0 (en) | 2018-05-15 | 2018-05-15 | Chimeric antigen receptor |
GB1809773.3 | 2018-06-14 | ||
GBGB1809773.3A GB201809773D0 (en) | 2018-06-14 | 2018-06-14 | Chimeric antigen receptor |
PCT/GB2019/051330 WO2019220109A1 (en) | 2018-05-15 | 2019-05-15 | Chimeric antigen receptor |
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JP2021522844A JP2021522844A (en) | 2021-09-02 |
JPWO2019220109A5 true JPWO2019220109A5 (en) | 2022-03-07 |
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EP (1) | EP3794034A1 (en) |
JP (2) | JP7335272B2 (en) |
CN (2) | CN118440211A (en) |
AU (1) | AU2019269118A1 (en) |
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WO2019025800A1 (en) * | 2017-08-02 | 2019-02-07 | Autolus Limited | Cells expressing a chimeric antigen receptor or engineered tcr and comprising a nucleotide sequence which is selectively expressed |
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US11661459B2 (en) | 2020-12-03 | 2023-05-30 | Century Therapeutics, Inc. | Artificial cell death polypeptide for chimeric antigen receptor and uses thereof |
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WO2023218381A1 (en) | 2022-05-11 | 2023-11-16 | Autolus Limited | Cd19/22 car t-cell treatment of high risk or relapsed pediatric acute lymphoblastic leukemia |
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2019
- 2019-05-15 CA CA3099831A patent/CA3099831A1/en active Pending
- 2019-05-15 EP EP19726081.3A patent/EP3794034A1/en active Pending
- 2019-05-15 JP JP2020564248A patent/JP7335272B2/en active Active
- 2019-05-15 AU AU2019269118A patent/AU2019269118A1/en active Pending
- 2019-05-15 US US17/054,670 patent/US11963981B2/en active Active
- 2019-05-15 WO PCT/GB2019/051330 patent/WO2019220109A1/en unknown
- 2019-05-15 CN CN202410424809.0A patent/CN118440211A/en active Pending
- 2019-05-15 CN CN201980032776.2A patent/CN112119096B/en active Active
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2022
- 2022-04-18 US US17/723,209 patent/US11590170B2/en active Active
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2023
- 2023-04-11 JP JP2023064079A patent/JP2023080185A/en active Pending
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