JP2022552748A - 抗cd47及び抗cd20による血液癌の治療 - Google Patents
抗cd47及び抗cd20による血液癌の治療 Download PDFInfo
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Abstract
Description
本出願は、2019年10月31日に出願された米国特許仮出願第62/928,988号、及び2020年5月28日に出願された米国特許仮出願第63/031,418号の利益を主張するものであり、これらの各々は、全ての目的のためにその全体が参照により本明細書に組み込まれる。
本出願は、ASCIIフォーマットで電子的に提出された配列表を含み、その全体が参照により本明細書に組み込まれる。2020年10月22日に作成された当該ASCIIコピーは、FSI-007_P2F_SL.txtと名付けられ、158,904バイトのサイズである。
定義
抗体
抗CD47剤
CD47抗体
抗SIRPα剤
SIRPα抗体
抗CD20抗体
an 4ネコ肉腫ウイルス癌遺伝子ホモログ(KIT)チロシンキナーゼ、ラクトフェリン、ラノステロール-14脱メチル化酵素、LDL受容体関連タンパク質-1、白血球免疫グロブリン様受容体サブファミリーBメンバー1(ILT2)、白血球免疫グロブリン様受容体サブファミリーBメンバー2(ILT4)、ロイコトリエンA4ヒドロラーゼ、リステリオリジン、L-セレクチン、黄体ホルモン受容体、リアーゼ、リンパ球活性化遺伝子3タンパク質(LAG-3)、リンパ球抗原75、リンパ球機能抗原-3受容体、リンパ球特異的タンパク質チロシンキナーゼ(LCK)、リンホタクチン、Lyn(Lck/Yes新型)チロシンキナーゼ、リジン脱メチル化酵素(KDM1、KDM2、KDM4、KDM5、KDM6、A/B/C/Dな)、リゾホスファチジン酸-1受容体、リソソーム関連膜タンパク質ファミリー(LAMP)遺伝子、リジルオキシダーゼホモログ2、リジルオキシダーゼタンパク質(LOX)、5-リポキシゲナーゼ(5-LOX)、造血前駆細胞キナーゼ1(HPK1)、肝細胞増殖因子受容体(MET)遺伝子、マクロファージコロニー刺激因子(MCSF)リガンド、マクロファージ遊走阻止因子、MAGEC1遺伝子、MAGEC2遺伝子、主要ヴォールトタンパク質、MAPK活性化プロテインキナーゼ(MK2など)、Mas関連G-タンパク質共役受容体、マトリックスメタロプロテアーゼ(MMP、例えばMMP2、MMP9)、Mcl-1分化タンパク質、Mdm2 p53結合タンパク質、Mdm4タンパク質、Melan-A(MART-1)メラノーマ抗原、メラニン形成細胞タンパク質Pmel 17、メラニン形成細胞刺激ホルモンリガンド、メラノーマ抗原ファミリーA3(MAGEA3)遺伝子、メラノーマ関連抗原(1、2、3、6など)、膜銅アミンオキシダーゼ、メソセリン、METチロシンキナーゼ、代謝調節型グルタミン酸受容体1、メタロレダクターゼSTEAP1(前立腺の6回膜貫通上皮抗原1)、メタスチン、メチオニンアミノペプチダーゼ-2、メチルトランスフェラーゼ、ミトコンドリア3ケトアシルCoAチオラーゼ、マイトジェン活性化プロテインキナーゼ(MAPK)、マイトジェン活性化プロテインキナーゼ(MEK、例えばMEK1、MEK2)、mTOR(ラパマイシンの機械的標的(セリン/スレオニンキナーゼ)、mTOR複合体(1、2など)、ムチン(1、5A、16など)、mut Tホモログ(MTH、例えばMTH1)、Myc癌原遺伝子タンパク質、骨髄系細胞白血病1(MCL1)遺伝子、ミリストイル化アラニンリッチプロテインキナーゼC基質(MARCKS)タンパク質、NAD ADPリボシルトランスフェラーゼ、ナトリウム利尿ペプチド受容体C、神経接着分子1、ニューロキニン1(NK1)受容体、ニューロキニン受容体、ニューロピリン2、NFκB活性化タンパク質、NIMA関連キナーゼ9(NEK9)、一酸化窒素シンターゼ、NK細胞受容体、NK3受容体、NKG2 A B活性化NK受容体、NLRP3(NACHT LRR PYDドメインタンパク質3)調節因子、ノルアドレナリントランスポーター、Notch(Notch-2受容体、Notch-3受容体、Notch-4受容体など)、核赤血球2関連因子2、核因子(NF)κB、ヌクレオリン、ヌクレオフォスミン、ヌクレオフォスミン-未分化リンパ腫キナーゼ(NPM-ALK)、2オキソグルタル酸デヒドロゲナーゼ、2,5-オリゴアデニル酸シンテターゼ、O-メチルグアニンDNAメチルトランスフェラーゼ、オピオイド受容体(δなど)、オルニチンデカルボキシラーゼ、オロト酸ホスホリボシルトランスフェラーゼ、オーファン核内ホルモン受容体NR4A1、オステオカルシン、破骨細胞分化因子、オステオポンチン、OX-40(腫瘍壊死因子受容体スーパーファミリーメンバー4 TNFRSF4、又はCD134)受容体、P3タンパク質、p38キナーゼ、p38 MAPキナーゼ、p53腫瘍抑制タンパク質、副甲状腺ホルモンリガンド、ペルオキシソーム増殖因子活性化受容体(PPAR、例えばα、δ、γ)、P-糖タンパク質(1など)、ホスファターゼテンシンホモログ(PTEN)、ホスファチジルイノシトール3-キナーゼ(PI3K)、ホスホイノシチド-3キナーゼ(PI3K、例えばα、δ、γ)、ホスホリラーゼキナーゼ(PK)、PKN3遺伝子、胎盤増殖因子、血小板由来増殖因子(PDGF、例えばα、β)、血小板由来増殖因子(PDGF、例えばα、β)、多面的薬物耐性トランスポーター、プレキシンB1、PLK1遺伝子、ポロ様キナーゼ(PLK)、ポロ様キナーゼ1、ポリ(ADP-リボース)ポリメラーゼ(PARP、例えばPARP1、PARP2及びPARP3、PARP7、及びモノ-PARP)、メラノーマで優先的に発現する抗原(PRAME)遺伝子、プレニル結合タンパク質(PrPB)、Probable転写因子PML、プロゲステロン受容体、プログラム細胞死1(PD-1)、プログラム細胞死リガンド1阻害因子(PD-L1)、プロサポシン(PSAP)遺伝子、プロスタノイド受容体(EP4)、プロスタグランジンE2シンターゼ、前立腺特異的抗原、前立腺酸性ホスファターゼ、プロテアソーム、タンパク質E7、タンパク質ファルネシルトランスフェラーゼ、プロテインキナーゼ(PK、例えばA、B、C)、タンパク質チロシンキナーゼ、タンパク質チロシンホスファターゼβ、癌原遺伝子セリン/スレオニン-タンパク質キナーゼ(PIM、例えばPIM-1、PIM-2、PIM-3)、P-セレクチン、プリンヌクレオシドホスホリラーゼ、プリン受容体P2Xリガンド感受性イオンチャネル7(P2X7)、ピルビン酸デヒドロゲナーゼ(PDH)、ピルビン酸デヒドロゲナーゼキナーゼ、ピルビン酸キナーゼ(PYK)、5-α-レダクターゼ、Rafプロテインキナーゼ(1、Bなど)、RAF1遺伝子、Ras遺伝子、Ras GTPアーゼ、RET遺伝子、Retチロシンキナーゼ受容体、網膜芽細胞腫関連タンパク質、レチノイン酸受容体(γなど)、レチノイドX受容体、Rheb(脳内に濃縮したRasホモログ)GTPアーゼ、Rho(Rasホモログ)関連プロテインキナーゼ2、リボヌクレアーゼ、リボヌクレオチドレダクターゼ(M2サブユニットなど)、リボソームタンパク質S6キナーゼ、RNAポリメラーゼ(I、IIなど)、Ron(Recepteur d’Origine Nantais)チロシンキナーゼ、ROS1(ROS癌原遺伝子1、受容体チロシンキナーゼ)遺伝子、Ros1チロシンキナーゼ、Runt関連転写因子3、γ-セクレターゼ、S100カルシウム結合タンパク質A9、筋小胞体カルシウムATPアーゼ、カスパーゼの第2のミトコンドリア由来活性化(SMAC)タンパク質、分泌されたfrizzled関連タンパク質-2、分泌されたホスホリパーゼA2、セマフォリン-4D、セリンプロテアーゼ、セリン/スレオニンキナーゼ(STK)、セリン/スレオニン-タンパク質キナーゼ(TBK、例えばTBK1)、シグナル伝達及び転写(STAT、例えばSTAT-1、STAT-3、STAT-5)、シグナルリンパ球活性化分子(SLAM)ファミリーメンバー7、前立腺の6回膜貫通上皮抗原(STEAP)遺伝子、SLサイトカインリガンド、スムーズンド(SMO)受容体、ヨウ化ナトリウムコトランスポーター、リン酸ナトリウムコトランスポーター2B、ソマトスタチン受容体(1、2、3、4、5など)、ソニックジホッグタンパク質、セブンレスの息子(SOS)、特異的タンパク質1(Sp1)転写因子、スフィンゴミエリンシンターゼ、スフィンゴシンキナーゼ(1、2など)、スフィンゴシン-1-リン酸受容体-1、脾臓チロシンキナーゼ(SYK)、SRC遺伝子、Srcチロシンキナーゼ、Stabilin-1(STAB1)、STAT3遺伝子、ステロイドスルファターゼ、インターフェロン刺激因子遺伝子(STING)受容体、インターフェロン刺激因子遺伝子タンパク質、間質細胞由来因子1リガンド、SUMO(低分子ユビキチン様修飾因子)、スーパーオキシドジスムターゼ、サイトカインシグナル調節因子の抑制因子(SOCS)、サバイビンタンパク質、シナプシン3、シンデカン-1、シヌクレインα、T細胞表面糖タンパク質CD28、tank結合キナーゼ(TBK)、TATAボックス結合タンパク質関連因子RNAポリメラーゼIサブユニットB(TAF1B)遺伝子、T細胞CD3糖タンパク質ζ鎖、T細胞分化抗原CD6、T細胞免疫グロブリン及びムチン-ドメイン含有-3(TIM-3)、T細胞表面糖タンパク質CD8、Tecタンパク質チロシンキナーゼ、Tekチロシンキナーゼ受容体、テロメラーゼ、テロメラーゼ逆転写酵素(TERT)遺伝子、テネイシン、3’末端修復エキソヌクレアーゼ1(TREX1)、3’末端修復エキソヌクレアーゼ2(TREX2)、トロンボポエチン受容体、チミジンキナーゼ、チミジンホスホリラーゼ、チミジル酸シンターゼ、チモシン(α1など)、甲状腺ホルモン受容体、甲状腺刺激ホルモン受容体、組織因子、TNF関連アポトーシス誘導リガンド、TNFR1関連デスドメインタンパク質、TNF関連アポトーシス誘導性リガンド(TRAIL)受容体、TNFSF11遺伝子、TNFSF9遺伝子、Toll様受容体(TLR、例えば1-13)、トポイソメラーゼ(I、II、IIIなど)、転写因子、トランスフェラーゼ、トランスフェリン(TF)、トランスフォーミング増殖因子α(TGFα)、トランスフォーミング増殖因子β(TGFB)及びこれらのアイソフォーム、TGFβ2リガンド、トランスフォーミング増殖因子TGF-β受容体キナーゼ、トランスグルタミナーゼ、転座関連タンパク質、膜貫通糖タンパク質NMB、Trop-2カルシウムシグナルトランスデューサー、トロホブラスト糖タンパク質(TPBG)遺伝子、トロホブラスト糖タンパク質、トロポミオシン受容体キナーゼ(Trk)受容体(TrkA、TrkB、TrkCなど)、トリプトファン2,3-ジオキシゲナーゼ(TDO)、トリプトファン5-ヒドロキシラーゼ、チューブリン、腫瘍壊死因子(TNF、例えばα、β)、腫瘍壊死因子13C受容体、腫瘍増殖座2(TPL2)、腫瘍タンパク質53(TP53)遺伝子、腫瘍抑制候補2(TUSC2)遺伝子、腫瘍特異的ネオ抗原、チロシナーゼ、チロシンヒドロキシラーゼ、チロシンキナーゼ(TK)、チロシンキナーゼ受容体、免疫グロブリン様及びEGF様ドメインを有するチロシンキナーゼ(TIE)受容体、チロシンプロテインキナーゼABL1阻害因子、ユビキチン、ユビキチンカルボキシルヒドロラーゼアイソザイムL5、ユビキチンチオエステラーゼ-14、ユビキチン抱合酵素E2I(UBE2I、UBC9)、ユビキチン特異的プロセシングプロテアーゼ7(USP7)、ウレアーゼ、ウロキナーゼプラスミノーゲン活性化因子、ウテログロビン、バニロイドVR1、血管細胞接着タンパク質1、血管内皮増殖因子受容体(VEGFR)、T細胞活性化のV-ドメインIg抑制因子(VISTA)、VEGF-1受容体、VEGF-2受容体、VEGF-3受容体、VEGF-A、VEGF-B、ビメンチン、ビタミンD3受容体、癌原遺伝子チロシンプロテインキナーゼ、Mer(Merチロシンキナーゼ受容体修飾因子)、YAP(Yes関連タンパク質調節因子、Wee-1タンパク質キナーゼ、ウェルナー症候群RecQ様ヘリカーゼ(WRN)、ウィルムス腫瘍抗原1、ウィルムス腫瘍タンパク質、WWドメイン含有転写制御タンパク質1(TAZ)、X連鎖アポトーシス抑制タンパク質、ジンクフィンガータンパク質転写因子、又はこれらの任意の組み合わせが挙げられるが、これらに限定されない。
阻害剤;MS203、PF-06939999、GSK3368715、GSK3326595などのPRMT阻害剤;オパガニブなどのスフィンゴシンキナーゼ2(SK2)阻害剤;オマベロキソロン(RTA-408)などの核赤血球2関連因子2刺激因子;LOXO-195、ONO-7579などのトロポミオシン受容体キナーゼ(TRK)阻害剤;GO-203-2Cなどのムチン1阻害剤;BIO-11006などのMARCKSタンパク質阻害剤;アルフォリチキソリンなどの葉酸アンタゴニスト;GR-MD-02などのガレクチン-3阻害剤;RX-5902などのリン酸化P68阻害剤;ofranergene obadenovecなどのCD95/TNF調節剤;INCB-053914などのpan-PIMキナーゼ阻害剤;EGEN-001、タボキノゲンテルセプラスミドなどのIL-12遺伝子刺激因子;TAS-116、PEN-866などの熱ショックタンパク質HSP90阻害剤;MP-0250などのVEGF/HGFアンタゴニスト;ベバシズマブのバイオシミラーなどのVEGFリガンド阻害剤;ラムシルマブなどのVEGF受容体アンタゴニスト/VEGFリガンド阻害剤;VEGF-1/VEGF-2/VEGF-3受容体アンタゴニスト;例えば、フルキンチニブ;HLA-A2402/HLA-A0201制限エピトープペプチドワクチンなどのVEGF-1/VEGF-2受容体調節剤;アフリベルセプトなどの胎盤成長因子リガンド阻害剤/VEGF-Aリガンド阻害剤;ASN-002などのSYKチロシンキナーゼ/JAKチロシンキナーゼ阻害剤;ラロトレクチニブ硫酸塩などのTrkチロシンキナーゼ受容体阻害剤;CS-12912などのJAK3/JAK1/TBK1キナーゼ阻害剤;AD-IL24などのIL-24アンタゴニスト;BMS-986299などのNLRP3(NACHT LRR PYDドメインタンパク質3)修飾因子;RGT-100などのRIG-Iアゴニスト;トプサリシンなどのエロリジン刺激物質;HM-30181AなどのP糖タンパク質1阻害剤;ARRY-382、BLZ-945などのCSF-1アンタゴニスト;JTX-1811、I-309、SB-649701、HG-1013、RAP-310などのCCR8阻害剤;SEL-403などの抗メソセリン抗体;アグラチマゲンベサデノベクアグラチマゲンベサデノベクなどのチミジンキナーゼ刺激因子;PCM-075、オンバンセルチブなどのPolo様キナーゼ1阻害剤;ペボネジスタット(MLN-4924)、TAS-4464などのNAE阻害剤;アバドミド(CC-122)などの多面経路調節剤;ペボネジスタットなどのアミロイドタンパク質結合タンパク質-1阻害剤/ユビキチンリガーゼ調節剤;チオストレプトプトンなどのFoxM1阻害剤;TAK-243などのUBA1阻害剤;VAL-201などのSrcチロシンキナーゼ阻害剤;VDA-1102などのVDAC/HK阻害剤;ロヒニチブ、eFT226などのElf4a阻害剤;ad-p53などのTP53遺伝子刺激物質;トレチノインなどのレチノイン酸受容体アゴニスト;SY-1425などのレチノイン酸受容体α(RARα)阻害剤;YC8-02などのSIRT3阻害剤;オラプテストペゴル(NOX-A12)などの間質細胞由来因子1リガンド阻害剤;MDNA-55などのIL-4受容体修飾因子;ペグジラリギナーゼなどのアルギナーゼI刺激因子;イリノテカン塩酸塩、OnivydeなどのトポイソメラーゼI阻害剤;PEG-SN38(フィルテカンペゴル)などのトポイソメラーゼI阻害剤/低酸素誘導因子-1α阻害剤;PT-2977、PT-2385などの低酸素誘導性因子-1α阻害剤;proleukin(アルデスロイキン、IL-2)などのCD122(IL-2受容体)アゴニスト;ペグ化IL-2(例えば、NKTR-214);IL-2の修飾されたバリアント(例えば、THOR-707);NKTR-262などのTLR7/TLR8アゴニスト;DS-0509、GS-9620、LHC-165、TMX-101(イミキモド)などのTLR7アゴニスト;ケベトリンなどのp53腫瘍抑制タンパク質刺激因子;ALRN-6924などのMdm4/Mdm2 p53結合タンパク質阻害剤;フィラネシブ(ARRY-520)などのキネシンスピンドルタンパク質(KSP)阻害剤;FPT-155などのCD80-fc融合タンパク質阻害剤;KO-539などのメニン及び混合形質型白血病(MLL)阻害剤;RGX-104などの肝臓x受容体アゴニスト;ペグイロデカキン(AM-0010)などのIL-10アゴニスト;ボロラニブなどのVEGFR/PDGFR阻害剤;CA-4948などのIRAK4阻害剤;OPN-305などの抗TLR-2抗体;CBP-501などのカルモジュリン修飾因子;
;nadofaragene firadenovecなどのアデノウイルスベクターワクチン;自己Gp96ワクチン;CVactm、tapuldencel-T、eltrapuldencel-T、SL-701、BSK01TM、rocapuldencel-T(AGS-003)、DCVAC、CVac(商標)、stapuldencel-T、eltrapuldencel-T、SL-701、BSK01(商標)、ADXS31-142、自家樹状細胞ワクチン(転移性悪性黒色腫、皮内/静脈内、Universitatsklinikum Erlangen)などの樹状細胞ワクチン;タリモジンラヘルパレプベク、pexastimogene devacirepvec、GL-ONC1、MG1-MA3、パルボウイルスH-1、ProstAtak、エナデノチュシレブ、MG1MA3、ASN-002(TG-1042)などの腫瘍溶解性ワクチン;CVAC-301、CMP-001、CreaVax-BC、PF-06753512、VBI-1901、TG-4010、ProscaVax(商標)などの治療ワクチン;Vigil(登録商標)(IND-14205)、Oncoquest-Lワクチンなどの腫瘍細胞ワクチン;PVS-RIPOなどの弱毒性組換え血清型1ポリオウイルスワクチン;Adagloxad simolenin;MEDI-0457;DPV-001腫瘍由来オートファゴソームリッチがんワクチン;CV-9209、LV-305などのRNAワクチン;MEDI-0457、MVI-816、INO-5401などのDNAワクチン;MVA-p53などのp53を発現する修飾されたワクシニアウイルスAnkaraワクチン;DPX-Survivac;BriaVax(商標);GI-6301;GI-6207;GI-4000;IO-103;AGEN-2017、GEN-010、NeoVax、RG-6180、GEN-009、PGV-001(TLR-3アゴニスト)、GRANITE-001、NEO-PV-01などのネオ抗原ペプチドワクチン;PhosphoSynVax(商標)などの熱ショックタンパク質を標的とするペプチドワクチン、Vitespen(HSPPC-96-C)、アルドキソルビシンを含有するNANT結腸直腸癌ワクチン、自家腫瘍細胞ワクチン+全身性CpG-B+IFN-α(癌)、IO-120+IO-103(PD-L1/PD-L2ワクチン)、HB-201、HB-202、HB-301、TheraT(登録商標)*系ワクチン;ポリICLC(NSC-301463)などのTLR-3アゴニスト/インターフェロン誘導因子; ナパブバカシン(BBI-608)などのSTAT-3阻害剤;CB-5083などのATPアーゼp97阻害剤;Odomzo(登録商標)(ソノデギブ、旧LDE-225)、LEQ506、ビスモデギブ(GDC-0449)、BMS-833923、グラスデギブ(PF-04449913)、LY2940680、及びイトラコナゾールなどの平滑化(SMO)受容体阻害剤;インターフェロンα-2b、インターフェロンα-2aバイオシミラー(Biogenomics)、ropegインターフェロンα-2b(AOP-2014、P-1101、PEG IFN α-2b)、マルチフェロン(アルファナチベ、Viragen)、インターフェロンα1b、ロフェロン-A(Roferon-A)(カンフェロン(Canferon)、Ro-25-3036)、インターフェロンα-2aフォローオンバイオ後続品(Biosidus)(インムタグ(Inmutag)、Inter 2A)、インターフェロンα-2Bバイオ後続品(Biosidus-ビオフェロン(Bioferon)、シトフェロン(Citopheron)、ガナパー(Ganapar)、Beijing Kawin Technology-カフェロン(Kaferon))、アルファフェロン(Alfaferone)、PEG化インターフェロンα-1b、pegインターフェロンα-2bバイオ後続品的(Amega)、組換えヒトインターフェロンα-1b、組換えヒトインターフェロンα-2a、組換えヒトインターフェロンα-2b、ベルツズマブ-IFNα2b共役体、Dynavax(SD-101)、及びインターフェロンα-n1(Humoferon、SM-10500、スミフェロン)などのインターフェロンαリガンド調節剤;インターフェロンγ(OH-6000、Ogamma100)などのインターフェロンγリガンド調節剤;テルトモチド(GV-1001、HR-2802、Riavax)及びイメテルスタット(GRN-163、JNJ-63935937)などのテロメラーゼ調節剤;テモゾロミド(CCRG-81045)、デシタビン、グアデシタビン(S-110、SGI-110)、KRX-0402、RX-3117、RRx-001、及びアザシチジン(CC-486)などのDNAメチルトランスフェラーゼ阻害剤;ピキサントロン及びソブゾキサンなどのDNAジャイレース阻害剤;アムルビシンなどのDNAジャイレース阻害剤/トポイソメラーゼII阻害剤;ABT-263、ベネトクラックス(ABT-199)、ABT-737、RG7601、及びAT-101などのBcl-2ファミリータンパク質阻害剤;novitoclaxなどのBcl-2/Bcl-XL阻害剤;LY3039478(クレニガアセタット)、タレクスツマブ(抗Notch2/3)、BMS-906024などのNotch阻害剤;PEGPH-20などのヒアルロニダーゼ刺激物質;Herceptin HylectaなどのErbb2チロシンキナーゼ受容体阻害剤/ヒアルロニダーゼ刺激剤;SM-04755、PRI-724、WNT-974などのWnt経路阻害剤;PF-03084014、MK-0752、RO-4929097などのγ-セクレターゼ阻害剤;BP1001などのGrb-2(増殖因子受容体結合タンパク質-2)阻害剤;ONC201、ABBV-621などのTRAIL経路誘導化合物;SCB-313などのTRAIL調節剤;VS-4718、デファクチニブ、GSK2256098などの接着斑キナーゼ阻害剤;サリデギブ、ソノデギブ(LDE225)、グラスデギブなどのヘッジホッグ阻害剤;アリセルチブ(MLN-8237)、及びAZD-2811、AMG-900、バラセルチブ、ENMD-2076などのオーロラキナーゼ阻害剤;ブリブジン、アタトルセンなどのHSPB1調節剤(熱ショックタンパク質27、HSP27);BAY-937、AZD6738、AZD6783、VX-803、VX-970(ベルゾセルチブ)及びVX-970などのATR阻害剤;AUY922、オナレスピブ(AT13387)、SNX-2112、SNX5422などのHsp90阻害剤;DS-3032b、RG7775、AMG-232、HDM201、及びイダザヌツリン(RG7388)などのマウス二重微小染色体(mdm2)癌遺伝子阻害剤;ウレルマブ、ウトミルマブ(PF-05082566)、AGEN2373、ADG-106、BT-7480、QL1806などのCD137アゴニスト;ADU-S100(MIW-815)、SB-11285、MK-1454、SR-8291、AdVCA0848、GSK-532、SYN-STING、MSA-1、SR-8291、GSK3745417などのSTINGアゴニスト;FGF-401、INCB-054828、BAY-1163877、AZD4547、JNJ-42756493、LY2874455、Debio-1347などのFGFR阻害剤;TVB-2640などの脂肪酸シンターゼ(FASN)阻害剤;A6などのCD44結合剤;LB-100などのタンパク質ホスファテアーゼ(phosphatease)2A(PP2A)阻害剤;セビテロンネル(VT-464)、ASN-001、ODM-204、CFG920、酢酸アビラテロンなどのCYP17阻害剤;IRX4204などのRXRアゴニスト;タラデギブ、パチデギブ、ビスモデギブなどのヘッジホッグ/平滑化(hh/Smo)アンタゴニスト;Imprime PGGなどの補体C3調節剤;ALT-803、NKTR-255、インターロイキン-15/Fc融合タンパク質、AM-0015、NIZ-985、及びhetIL-15などのIL-15アゴニスト;タゼメトスタット、CPI-1205、GSK-2816126、PF-06821497などのEZH2(zesteホモログのエンハンサー2)阻害剤;pelareorep、CG-0070、MV-NIS療法、HSV-1716、DS-1647、VCN-01、ONCOS-102、TBI-1401、tasadenoturev(DNX-2401)、vocimagene amiretrorepvec、RP-1、CVA21、Celyvir、LOAd-703、OBP-301、IMLYGIC(登録商標)などの腫瘍溶解性ウイルス;pinometostat(EPZ-5676)などのDOT1L(ヒストンメチルトランスフェラーゼ)阻害剤;コレラトキシン、リシン、シュードモナス・エクソトキシン、百日咳菌アデニル酸シクラーゼトキシン、ジフテリアトキシン、及びカスパーゼ活性化因子などのトキシン;BC-819などのDNAプラスミド;ボラセルチブ(PLK1)などのPLK1、2、及び3のPLK阻害剤;AZD-1775(アダボセルチブ)などのWEE1阻害剤;AT13148、KD025などのRhoキナーゼ(ROCK)阻害剤;ASTX660、debio-1143、ビリナパント、APG-1387、LCL-161などのアポトーシス阻害タンパク質(IAP)阻害剤;ルルビネクテジン(PM-1183)、CX-5461などのRNAポリメラーゼ阻害剤;PM-184、BAL-101553(リサバンブリン)、及びOXI-4503、フルオラパシン(AC-0001)、プリナブリン、ビンフルニンなどのチューブリン阻害剤;G100、GSK1795091、及びPEPA-10などのToll様受容体4(TLR-4)アゴニスト;プリチデプシンなどの伸長因子1α2阻害剤;デニロイキンジフチトクスなどの伸長因子2阻害剤/インターロイキン-2リガンド/NAD ADPリボシルトランスフェラーゼ刺激剤;APG-101、APO-010、アスネルセプトなどのCD95阻害剤;DSP-7888などのWT1阻害剤;H3B-8800などのスプライシング因子3Bサブユニット1(SF3B1)阻害剤;LYC-55716などのレチノイドZ受容体ガンマ(RORγ)アゴニスト;並びに、SER-401、EDP-1503、MRx-0518などのマイクロバイオーム調節剤。
TNF受容体スーパーファミリー(TNFRSF)メンバーのアゴニスト又は活性化因子
免疫チェックポイント阻害剤
Toll様受容体(TLR)アゴニスト
TCRシグナル伝達調節因子
アデノシン生成及びシグナル伝達
二重特異性T細胞誘導因子(Bi-Specific T-Cell Engager)
二重及び三重特異性ナチュラルキラー(NK)細胞誘導因子
造血前駆細胞キナーゼ1(HPK1)阻害剤
アポトーシスシグナル調節キナーゼ(ASK)阻害剤
ブルトン型チロシンキナーゼ(BTK)阻害剤
サイクリン依存性キナーゼ(CDK)阻害剤
ジスコイジンドメイン受容体(DDR)阻害剤
ヒストンデアセチラーゼ(HDAC)阻害剤
インドレアミン-ピロール-2,3-ジオキシゲナーゼ(IDO1)阻害剤;
ヤヌスキナーゼ(JAK)阻害剤
マトリックスメタロプロテアーゼ(MMP)阻害剤
RAS及びRAS経路阻害剤
脾臓チロシンキナーゼ(SYK)阻害剤
チロシンキナーゼ阻害剤(TKI)
化学療法剤(標準治療)
抗血管新生剤
抗線維化剤
抗炎症剤
腫瘍酸素化剤
免疫療法剤
がん遺伝子療法及び細胞療法
細胞療法
腫瘍を標的とするための追加の薬剤
MCL1アポトーシス調節物質、BCL2ファミリーメンバー(MCL1)阻害剤
サイトカイン誘導性SH2含有タンパク質(CISH)阻害剤
遺伝子エディタ
不特定の標的を有する他の薬物
例示的な併用療法
リンパ腫又は白血病併用療法
非ホジキンリンパ腫の併用療法
マントル細胞リンパ腫の併用療法
ワルデンシュトレーム型マクログロブリン血症の併用療法
びまん性大細胞型B細胞リンパ腫併用療法
慢性リンパ球白血病併用療法
骨髄線維症の併用療法
過剰増殖性障害併用療法
癌
CD20+癌
アッセイ
%RO=100-((MFI試験-MFI未染色)/(MFI飽和STD-MFI不飽和))×100
使用方法
更なる併用療法
対象の状態、適格性、及び治療
B細胞の存在に関する免疫組織化学的分析
投薬
プライマー剤及びプライミング用量
投与サイクル
サイクル1(4週間)
- 1日目の1mg/kg抗CD47のプライミング用量
- 8日目に開始する30mg/kg抗CD47の週間用量
- 8日目に開始する375mg/m2リツキシマブ又は抗CD20抗体同等用量の週間用量
サイクル2(4週間)
- 30mg/kg抗CD47の週間用量
- 375mg/m2リツキシマブ又は抗CD20抗体同等用量の月間用量
サイクル3~5
- 隔週30mg/kg抗CD47
- 375mg/m2リツキシマブ又は抗CD20抗体同等用量の月間用量
サイクル6+(臨床的利益を失うまで継続)
- 隔週30mg/kg用量の抗CD47
- 375mg/m2リツキシマブ又は抗CD20抗体同等用量の隔月投与
投与
臨床的エンドポイント
医薬組成物
キット
配列
実施例1:再発性/難治性B細胞非ホジキンリンパ腫を有するヒト患者におけるリツキシマブと併用したHu5F9-G4。
序論
患者適格性
1. 18歳以上の成人
2. 第1b相のみ:免疫組織化学的(IHC)又はフローサイトメトリーによってCD20を発現しているB細胞NHL、少なくとも2種類の前治療に対して再発性又は難治性
3. DLBCL第2相コホート:IHC又はフローサイトメトリーによってCD20を発現している組織学的に確認された新規又は形質転換を伴ったDLBCL、第一選択療法に対して難治性、又は、第二選択療法である救済レジメン若しくは自家造血肝細胞移植に対して再発性若しくは難治性
4. 低悪性度リンパ腫第2相コホート:IHC又はフローサイトメトリーによってCD20を発現している組織学的に確認された辺縁帯又は濾胞性リンパ腫(グレード1~3a)、少なくとも2種類の前治療に対して再発性又は難治性
5. Eastern Cooperative Oncology Group(ECOG)スコア0~2
6. リンパ腫のLugano分類による応答について測定可能又は評価可能な疾患
7. 臨床検査値、血球数:
○ヘモグロビン≧9.5g/dL
○絶対好中球数(ANC)≧1.0×109/mL
○血小板≧50×109/mL
8. 臨床検査値、肝機能:
○アスパラギン酸アミノトランスフェラーゼ(AST)/アラニンアミノトランスフェラーゼ(ALT)<5×正常上限(ULN)
○ビリルビン≦1.5×又は3.0×ULN、及び患者がジルベール症候群又は遺伝的に同等の既往を有する場合、主に非抱合型
9. 臨床検査値、腎機能:
○血清クレアチニン≦1.5×ULN、又は糸球体濾過率(GFR)計算値>40mL/分/1.73m2
10. 妊娠の可能性がある女性は、登録前30日以内及びHu5F9-G4の初回投与72時間以内の尿又は血清妊娠検査陰性。
11. 妊娠の可能性がある女性は、試験中及びリツキシマブ最終投与の12ヶ月後又はHu5F9-G4最終投与の4ヶ月後のいずれか遅い方まで、1種類の非常に効果的な避妊方法を使用する意思があること
12. パートナーが妊娠の可能性がある女性の場合、男性は、試験中及びリツキシマブ最終投与の12ヶ月後又はHu5F9-G4最終投与の4ヶ月後のいずれか遅い方まで、1種類の効果的な避妊方法を使用する意思があること
13. 対象はインフォームドコンセントを提示している
14. 試験プロトコルに説明されている通院及び手技に準拠する意思があり、準拠可能であること
15. 第2相のみ:治験責任医師によって実行不可能(理由としては、生検に利用可能な腫瘍組織の欠如及び患者安全性の懸念が挙げられるが、これらに限定されない)と定められない限り、1回の必須の治療前及び1回の治療中の腫瘍生検に同意する意思があること
1. 活動性脳転移を有する患者。(少なくとも3週間コルチコステロイド療法が行われず、安定的に治療されている中枢神経系[CNS]病変を有する患者は、活動性とは見なされない。)
2. Hu5F9-G4投与前2週間以内又は少なくとも4×半減期以内(最大4週間まで、いずれか長い方)の化学療法、ホルモン療法、又は治験薬などの事前抗癌療法。全ての状況において、必要な最大ウォッシュアウト期間は、Hu5F9-G4の最初の投与日前4週間を超えない。低用量ステロイド(経口プレドニゾン又は同等物、1日当たり≦20mg)、局所的非CNS放射線療法、前立腺癌に対するLHRHアゴニストを用いた既存の事前ホルモン療法、及びビスホスホネート及びRANKL阻害剤による治療は、除外基準ではない。
3. 既知の活性又は慢性B型若しくはC型肝炎感染、又はヒト免疫不全ウイルス(HIV)。
4. 赤血球(RBC)輸血依存、スクリーニング前4週間の2単位を超えるRBC輸血を要するものとして定義される。RBC輸血は、スクリーニング中、及びヘモグロビンの組み入れ基準を満たすため登録前に許可される。
5. 直近3ヶ月間の溶血性貧血又はエヴァンス症候群の病歴。
6. 直接抗グロブリン試験(DAT)陽性。
7. CD47又はシグナル調節タンパク質アルファ(SIRPα)標的化剤による前治療。
8. 治療された基底細胞若しくは限局性扁平上皮皮膚癌、限局性前立腺癌、又は、患者が除外基準2に定義されるような抗癌治療を実施されていない他の悪性腫瘍を除く、二次癌。
9. 活性物質、マウスタンパク質、又は以下に記載されるに対するリツキシマブの他の賦形剤のいずれかに対する過敏症:RITUXAN(登録商標)(リツキシマブ)処方情報
http://www.gene.com/download/pdf/rituxan_prescribing.pdf; MabThera(登録商標)(リツキシマブ)処方情報 http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000165/WC500025821.pdf。各リンクは、2017年4月27日現在である。
10. 治験責任医師及び治験依頼者によって評価されるとき、試験への参加においてリスク対ベネフィット比を実質的に増加させる顕著な医学的疾患又は状態。これには、直近6ヶ月以内の急性心筋梗塞、不安定狭心症、コントロール不良の糖尿病、顕著な活動性感染、重度の免疫不全状態、及びうっ血性心不全New York Heart Association(NYHA)クラスII~IVが挙げられるが、これらに限定されない。
11. 精神疾患又は物質乱用の病歴は、プロトコル要件への準拠又はインフォームドコンセントの提示能力を妨げる可能性が高い。
12. 妊娠中又は授乳中。
試験目的
エンドポイント
介入及び送達方法
介入期間と評価
患者数
Hスコア
奏効率に影響を与える変数の遡及的分析
改良した患者適格性基準を用いて計画された試験
患者奏効率
奏効率に影響を与える変数の遡及的分析
CD19+B細胞の存在
CD20+B細胞の存在
CD19+及びCD20+B細胞の両方の存在
直近の抗CD20治療の期間
対象におけるリツキシマブ濃度
実施例3:Q1W対Q2WのHu5F9-G4投与レジメンにおける抗体受容体占有率
特定の実施形態では、例えば以下の項目が提供される。
(項目1)
対象における血液癌の治療方法であって、(a)CD47とSIRPαとの間の結合を阻害する抗CD47剤を投与することと、(b)抗CD20抗体を前記対象に投与することと、を含み、工程(a)及び(b)を実施する前に、B細胞が前記対象に存在していることが決定されるか、又は決定されている、方法。
(項目2)
対象における血液癌の治療方法であって、
B細胞が前記対象に存在することを決定すること又は決定されていることと、
(i)CD47とSIRPαとの間の結合を阻害する抗CD47剤、及び(ii)抗CD20抗体を、前記対象に投与すること又は投与されていることと、を含む、方法。
(項目3)
B細胞が前記対象に存在することの前記決定が、フローサイトメトリー、B細胞耐性パネル、ELISA、免疫組織化学的顕微鏡検査、RNAプロファイリング、RNA配列決定、RNAアレイ系検出、RT-PCR、ノーザンブロット、免疫グロブリン配列決定、ウエスタンブロット、酵素結合免疫スポット、又は免疫蛍光顕微鏡検査から選択される少なくとも1つのアッセイを実施すること又は実施されていることを含む、項目1~2のいずれか一項に記載の方法。
(項目4)
前記抗CD47剤及び前記抗CD20抗体を前記対象に投与する前に、B細胞が前記対象に存在することの前記決定を前提として、前記対象を治療の候補者であると決定することを更に含む、項目1~3のいずれか一項に記載の方法。
(項目5)
B細胞が前記対象に存在することの前記決定は、前記対象がCD19+B細胞を有すると決定すること又は決定されていることを含む、項目1~4のいずれか一項に記載の方法。
(項目6)
前記対象がCD19+B細胞を有すると決定すること又は決定されていることは、前記対象がCD19+B細胞を閾値量を超えて有すると決定すること又は決定されていることを含む、項目5に記載の方法。
(項目7)
CD19+B細胞の前記閾値量が、CD19+B細胞の存在を決定するために使用されるアッセイの検出限界である、項目6に記載の方法。
(項目8)
CD19+B細胞の前記閾値量が、リンパ球の総集団のうち少なくとも5パーセントのCD19+B細胞である、項目6に記載の方法。
(項目9)
CD19+B細胞の前記閾値量が、マイクロリットル当たり少なくとも1個のCD19+B細胞である、項目6に記載の方法。
(項目10)
CD19+B細胞の前記閾値量が、マイクロリットル当たり少なくとも40個のCD19+B細胞である、項目6に記載の方法。
(項目11)
B細胞が前記対象に存在することの前記決定は、前記対象がCD20+B細胞を有すると決定すること又は決定されていることを含む、項目1~4のいずれか一項に記載の方法。
(項目12)
前記対象がCD20+B細胞を有すると決定すること又は決定されていることは、前記対象がCD20+B細胞を閾値量を超えて有すると決定すること又は決定されていることを含む、項目11に記載の方法。
(項目13)
CD20+B細胞の前記閾値量が、CD20+B細胞の存在を決定するために使用されるアッセイの検出限界である、項目11に記載の方法。
(項目14)
CD20+B細胞の前記閾値量が、リンパ球の総集団のうち少なくとも5パーセントのCD20+B細胞である、項目11に記載の方法。
(項目15)
CD20+B細胞の前記閾値量が、マイクロリットル当たり少なくとも1個のCD20+B細胞である、項目11に記載の方法。
(項目16)
CD20+B細胞の前記閾値量が、マイクロリットル当たり少なくとも40個のCD20+B細胞である、項目11に記載の方法。
(項目17)
B細胞が前記対象に存在することの前記決定は、前記対象がCD19+B細胞及びCD20+B細胞の両方を有すると決定すること又は決定されていることを含む、項目1~4のいずれか一項に記載の方法。
(項目18)
前記対象がCD19+B細胞及びCD20+B細胞の両方を有すると決定すること又は決定されていることは、前記対象がCD19+B細胞及びCD20+B細胞を閾値量を超えて有すると決定すること又は決定されていることを含む、項目17に記載の方法。
(項目19)
CD19+B細胞の前記閾値量が、CD19+B細胞の存在を決定するために使用されるアッセイの検出限界、リンパ球の総集団のうち少なくとも5パーセントのCD19+B細胞、マイクロリットル当たり少なくとも1個のCD19+B細胞、又はマイクロリットル当たり少なくとも40個のCD19+B細胞のうち、いずれか1つである、項目18に記載の方法。
(項目20)
CD20+B細胞の前記閾値量が、CD20+B細胞の存在を決定するために使用されるアッセイの検出限界、リンパ球の総集団のうち少なくとも5パーセントのCD20+B細胞、マイクロリットル当たり少なくとも1個のCD20+B細胞、又はマイクロリットル当たり少なくとも40個のCD20+B細胞のうち、いずれか1つである、項目18又は19に記載の方法。
(項目21)
B細胞が前記対象に存在することの前記決定は、前記対象が閾値期間を超えて以前に抗CD20療法剤を投与されたことを決定すること又は決定されていることを含む、項目1~20のいずれか一項に記載の方法。
(項目22)
前記閾値期間が、少なくとも4週間である、項目21に記載の方法。
(項目23)
前記閾値期間が、少なくとも5、6、7、8、9、10、11、12、13、14、15、16、17、18、19、20、21、22、23、24、25、26、27、又は28週間である、項目21に記載の方法。
(項目24)
B細胞が前記対象に存在することの前記決定は、前記対象において抗CD20療法剤が存在していないことを決定すること又は決定されていることを含む、項目1~23のいずれか一項に記載の方法。
(項目25)
前記対象において前記抗CD20療法剤が存在していないことを決定すること又は決定されていることは、前記対象が抗CD20療法剤の閾値濃度を下回って有していることを決定すること又は決定されていることを含む、項目24に記載の方法。
(項目26)
前記抗CD20療法剤の前記閾値濃度が、抗CD20療法剤の存在を検出するために使用される検出アッセイの定量限界である、項目25に記載の方法。
(項目27)
前記抗CD20療法剤の存在を検出するために使用される前記検出アッセイが、イムノアッセイ、ELIspot、フルオロスポット、フローサイトメトリー系アッセイ、ウエスタンブロット、LC質量分析、又は表面プラズモン共鳴のうちの1つである、項目26に記載の方法。
(項目28)
以前に投与された抗CD20療法剤がリツキシマブを含む、項目21~27のいずれか一項に記載の方法。
(項目29)
B細胞が、前記対象から得られたサンプルを使用して、前記対象に存在すると決定されるか又は決定されている、項目1~28のいずれか一項に記載の方法。
(項目30)
前記対象から得られた前記サンプルが、末梢血サンプルである、項目29に記載の方法。
(項目31)
前記抗CD47剤が、CD47とSIRPαとの間の結合を阻害する単離された抗体を含む、項目1~30のいずれか一項に記載の方法。
(項目32)
前記抗CD47剤が、SIRPα試薬を含む、項目1~31のいずれか一項に記載の方法。
(項目33)
前記SIRPα試薬が、CD47に結合するSIRPαの一部を含む、項目32に記載の方法。
(項目34)
前記SIRPα試薬が、高親和性SIRPα試薬である、項目32又は33に記載の方法。
(項目35)
前記抗CD47剤が、抗CD47抗体又は抗SIRPα抗体を含む、項目1~34のいずれか一項に記載の方法。
(項目36)
前記抗CD47剤が、マグロリマブ(Hu5F9-G4)を含む、項目1~35のいずれか一項に記載の方法。
(項目37)
前記抗CD47剤が、Hu1H9-G1、Hu1H9-G4、Hu3C2-G1、Hu3C2-G4、9B11-G1、9B11-G4、7E11-G1、及び7E11-G4のうちの少なくとも1つを含む、項目1~36のいずれか一項に記載の方法。
(項目38)
前記血液癌が、びまん性大細胞型B細胞リンパ腫(DLBCL)である、項目1~37のいずれか一項に記載の方法。
(項目39)
前記対象が、再発性又は難治性DLBCLを有する、項目1~38のいずれか一項に記載の方法。
(項目40)
前記対象が、以前に少なくとも2種類の治療法で治療されている、項目39に記載の方法。
(項目41)
前記血液癌が、濾胞性リンパ腫(FL)である、項目1~37のいずれか一項に記載の方法。
(項目42)
前記血液癌が、非ホジキンリンパ腫、辺縁帯リンパ腫、マントル細胞リンパ腫、慢性リンパ性白血病/小リンパ性白血病、ワルデンストレームマクログロブリン血症/リンパ形質細胞性リンパ腫、縦隔原発B細胞リンパ腫、バーキットリンパ腫、B細胞リンパ腫未分類型、B細胞急性リンパ芽球性白血病、又は移植後リンパ増殖性疾患(PTLD)のうちの1つである、項目1~37のいずれか一項に記載の方法。
(項目43)
前記抗CD47剤が、体重1kg当たり少なくとも10~30、20~30、10、15、20、又は30mgの用量で投与される、項目1~42のいずれか一項に記載の方法。
(項目44)
前記抗CD47剤が静脈内投与される、項目1~43のいずれか一項に記載の方法。
(項目45)
前記抗CD20抗体が静脈内投与される、項目1~44のいずれか一項に記載の方法。
(項目46)
CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、抗CD47抗体であり、前記抗CD47抗体は、体重1kg当たり少なくとも1mg抗体の1日目のプライミング用量と、体重1kg当たり少なくとも30mgの8日目に開始する4週間の週間用量と、を含む、初回サイクルで前記対象に投与される、項目1~45のいずれか一項に記載の方法。
(項目47)
CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、体重1kg当たり少なくとも30mgの4週間の週間用量を含む、2回目のサイクルで前記対象に更に投与される、項目46に記載の方法。
(項目48)
CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、体重1kg当たり少なくとも30mgの隔週用量を含む、3回目のサイクルで前記対象に更に投与される、項目47に記載の方法。
(項目49)
CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、体重1kg当たり少なくとも30mgの隔週用量を含む、後続サイクルで前記対象に更に投与される、項目48に記載の方法。
(項目50)
前記後続サイクルが、限定することなく、又は臨床的利益が低減若しくは消滅するか、又は観察されなくなるまで、1回以上の追加のサイクルとして繰り返される、項目49に記載の方法。
(項目51)
前記初回サイクルが、体表面積1m 2 当たり375mgの週間用量の抗CD20抗体を更に含む、項目46~50のいずれか一項に記載の方法。
(項目52)
前記2回目のサイクルが、体表面積1m 2 当たり375mgの月間用量の抗CD20抗体を更に含む、項目47~51のいずれか一項に記載の方法。
(項目53)
前記3回目のサイクルが、体表面積1m 2 当たり375mgの月間用量の抗CD20抗体を更に含む、項目48~52のいずれか一項に記載の方法。
(項目54)
前記後続サイクルが、体表面積1m 2 当たり375mgの隔月用量の抗CD20抗体を更に含む、項目49~53のいずれか一項に記載の方法。
(項目55)
前記抗CD20抗体が、100、125、150、175、200、225、250、275、300、325、350、375、400、425、450、475、又は500mg/m 2 のいずれか1つの用量で前記対象に投与される、項目1~50のいずれか一項に記載の方法。
(項目56)
前記抗CD47剤及び前記抗CD20抗体が両方とも前記対象に投与される日に、前記抗CD47剤が、前記抗CD20抗体の前に前記対象に投与される、項目1~55のいずれか一項に記載の方法。
(項目57)
前記抗CD47剤及び前記抗CD20抗体が両方とも前記対象に投与される日に、前記抗CD20抗体が、前記抗CD47剤の前に対象に投与される、項目1~55のいずれか一項に記載の方法。
(項目58)
化学療法剤を前記対象に投与することを更に含む、項目1~57のいずれか一項に記載の方法。
(項目59)
前記化学療法剤が、ゲムシタビン、オキサリプラチン、又はゲムシタビンとオキサリプラチンの組み合わせ(GEMOX)である、項目58に記載の方法。
(項目60)
前記抗CD20抗体がリツキシマブを含む、項目1~59のいずれか一項に記載の方法。
(項目61)
前記抗CD20抗体が、配列番号131~136の配列を含む1つ、2つ、3つ、4つ、5つ、又は6つの相補性決定領域(CDR)を含む、項目1~60のいずれか一項に記載の方法。
(項目62)
前記抗CD20抗体が、配列番号137の可変重鎖配列を含む、項目1~61のいずれか一項に記載の方法。
(項目63)
前記抗CD20抗体が、配列番号142の可変軽鎖配列を含む、項目1~62のいずれか一項に記載の方法。
(項目64)
前記抗CD20抗体がFc領域を含み、前記Fc領域は、配列番号140のC H2 配列及び配列番号141のC H3 配列を含む、項目1~63のいずれか一項に記載の方法。
(項目65)
前記抗CD20抗体がFab又はscFvを含み、前記Fab又はscFvは、配列番号137の可変重鎖配列及び配列番号142の可変軽鎖配列を含む、項目1~64のいずれか一項に記載の方法。
(項目66)
前記抗CD20抗体がFab又はscFvを含み、前記Fab又はscFvは、配列番号131~136の配列を含む、項目1~65のいずれか一項に記載の方法。
(項目67)
対象における血液癌の治療方法であって、前記方法は、
B細胞が前記対象に存在することを決定すること又は決定されていることであって、前記決定は、前記対象が、リンパ球の総量のうち少なくとも5パーセントのCD19+B細胞を有すると決定すること又は決定されていることを含む、ことと、
マグロリマブを投与すること;と、
前記対象にリツキシマブを投与することと、を含み、
前記対象は、以前に少なくとも2種類の治療法で治療されているヒト対象であり、
前記血液癌は、再発性又は難治性DLBCLであり、
マグロリマブを投与することは、(1)1日目に、体重1kg当たり1mg~10mg(例えば、1mg~5mg、例えば、1mg、2mg、3mg、4mg、5mg)の抗体の範囲のプライミング用量のマグロリマブを投与することと、(2)体重1kg当たり30mgで週間用量のマグロリマブを8週間投与することと、(3)以降体重1kg当たり30mgで隔週用量のマグロリマブを投与することと、を含み、
リツキシマブを投与することは、(1)体表面積1m 2 当たり375mgで週間用量のリツキシマブを4週間投与することと、その後、(2)体表面積1m 2 当たり375mgで毎月リツキシマブを投与することと、を含む、方法。
(項目68)
方法であって、
対象が直近に閾値期間を超えて以前に抗CD20療法剤を投与されたかどうかに基づいて、B細胞が血液癌を有する前記対象に存在するかどうかを決定することであって、前記対象が直近に閾値期間を超えて以前に抗CD20療法剤を投与されていることは、B細胞が前記対象に存在することを示す、ことを含み、
前記対象におけるB細胞の存在は、前記対象が、1)CD47とSIRPαとの間の結合を阻害する抗CD47剤と、2)リツキシマブと、を含む、治療に応答する可能性が高いことを示し、
前記対象におけるB細胞の非存在は、前記対象が、1)CD47とSIRPαとの間の結合を阻害する抗CD47剤と、2)リツキシマブと、を含む、治療に応答する可能性が低いことを示す、方法。
(項目69)
方法であって、
血液癌を有する対象からサンプルを得ることと、
前記対象から得られたサンプルでアッセイを実施することによってB細胞が存在するかどうかを決定することと、を含み、
前記対象におけるB細胞の存在は、前記対象が、1)CD47とSIRPαとの間の結合を阻害する抗CD47剤と、2)リツキシマブと、を含む、治療に応答する可能性が高いことを示し、
前記対象におけるB細胞の非存在は、前記対象が、1)CD47とSIRPαとの間の結合を阻害する抗CD47剤と、2)リツキシマブと、を含む、治療に応答する可能性が低いことを示す、方法。
(項目70)
前記対象から得られた前記サンプルが、末梢血サンプルである、項目69に記載の方法。
(項目71)
方法であって、
血液癌を有する対象におけるB細胞の存在を示す情報を含むデータセットを取得すること又は取得されていることであって、前記血液癌を有する対象におけるB細胞の存在を示す前記情報は、
前記対象におけるB細胞の量、
前記対象における全リンパ球中のB細胞の割合、
前記対象が直近に抗CD20療法剤を投与された日数、
前記対象における抗CD20療法剤の存在又は非存在、のうちの1つを含む、ことと、
前記データセットを使用して、B細胞が前記血液癌を有する対象に存在することを決定することと、
前記血液癌を有する対象に治療を施すことと、を含む、方法。
(項目72)
前記データセットを取得すること又は取得されていることは、フローサイトメトリー、B細胞耐性パネル、ELISA、免疫組織化学的顕微鏡検査、RNAプロファイリング、RNA配列決定、RNAアレイ系検出、RT-PCR、ノーザンブロット、免疫グロブリン配列決定、ウエスタンブロット、ELIspot、又は免疫蛍光顕微鏡検査から選択される少なくとも1つのアッセイを実施すること又は実施されていることを含む、項目71に記載の方法。
(項目73)
前記データセット内の前記情報は、前記対象から得られたサンプル中のB細胞の量、又は前記対象から得られたサンプル中のB細胞の割合のうちのいずれか1つを含み、B細胞が前記対象に存在することを決定することは、前記情報を、B細胞の閾値量と比較することを含む、項目71又は72に記載の方法。
(項目74)
B細胞の前記閾値量が、リンパ球の総集団のうち少なくとも5パーセントのB細胞である、項目73に記載の方法。
(項目75)
B細胞の前記閾値量が、少なくとも、B細胞の存在を決定するために使用されるアッセイの検出限界である、項目73に記載の方法。
(項目76)
B細胞の前記閾値量が、マイクロリットル当たり少なくとも1個のB細胞である、項目73に記載の方法。
(項目77)
B細胞の前記閾値量が、マイクロリットル当たり少なくとも40個のB細胞である、項目73に記載の方法。
(項目78)
前記B細胞が、CD19+B細胞又はCD20+B細胞のうちの1つである、項目71~77のいずれか一項に記載の方法。
(項目79)
前記B細胞が、CD19+B細胞及びCD20+B細胞の両方である、項目71~77のいずれか一項に記載の方法。
(項目80)
前記データセット内の前記情報は、前記対象が以前に抗CD20療法剤を投与された期間を含み、B細胞が前記対象に存在することを決定することは、前記対象が以前に抗CD20療法剤を投与された前記期間が閾値期間を超えるかどうかを決定することを含む、項目71~79のいずれか一項に記載の方法。
(項目81)
前記閾値期間が、少なくとも4週間である、項目80に記載の方法。
(項目82)
前記閾値期間が、少なくとも5、6、7、8、9、10、11、12、13、14、15、16、17、18、19、20、21、22、23、24、25、26、27、又は28週間である、項目80に記載の方法。
(項目83)
前記データセット内の前記情報は、前記対象における抗CD20療法剤の存在又は非存在を含み、B細胞が前記対象に存在することを決定することは、前記対象において抗CD20療法剤が存在していないことを決定することを含む、項目71~82のいずれか一項に記載の方法。
(項目84)
前記対象における抗CD20療法剤が存在していないことを決定することは、前記対象が前記抗CD20療法剤の閾値濃度を下回って有することを決定すること又は決定されていることを含む、項目83に記載の方法。
(項目85)
前記抗CD20療法剤の前記閾値濃度が、抗CD20療法剤の存在を検出するために使用される検出アッセイの定量限界である、項目84に記載の方法。
(項目86)
前記抗CD20療法剤の存在を検出するために使用される前記検出アッセイが、イムノアッセイ、酵素結合免疫スポット、フルオロスポット、フローサイトメトリー系アッセイ、ウエスタンブロット、LC質量分析、又は表面プラズモン共鳴のうちの1つである、項目85に記載の方法。
(項目87)
以前に投与された抗CD20療法剤がリツキシマブを含む、項目80~86のいずれか一項に記載の方法。
(項目88)
前記血液癌が、びまん性大細胞型B細胞リンパ腫(DLBCL)である、項目68~87のいずれか一項に記載の方法。
(項目89)
前記血液癌が、再発性又は難治性DLBCLである、項目68~87のいずれか一項に記載の方法。
(項目90)
前記対象が、以前に少なくとも2種類の治療法で治療されている、項目68~89のいずれか一項に記載の方法。
(項目91)
前記血液癌が、濾胞性リンパ腫(FL)である、項目68~87のいずれか一項に記載の方法。
(項目92)
前記血液癌が、非ホジキンリンパ腫、辺縁帯リンパ腫、マントル細胞リンパ腫、慢性リンパ性白血病/小リンパ性白血病、ワルデンストレームマクログロブリン血症/リンパ形質細胞性リンパ腫、縦隔原発B細胞リンパ腫、バーキットリンパ腫、B細胞リンパ腫未分類型、B細胞急性リンパ芽球性白血病、又は移植後リンパ増殖性疾患(PTLD)のうちの1つである、項目68~87のいずれか一項に記載の方法。
(項目93)
前記治療を施すことが、CD47とSIRPα,との間の結合を阻害する抗CD47剤を投与することと、前記対象に抗CD20抗体を投与することと、を含む、項目71~92のいずれか一項に記載の方法。
(項目94)
前記抗CD47剤が、CD47とSIRPαとの間の結合を阻害する単離された抗体を含む、項目93に記載の方法。
(項目95)
前記抗CD47剤が、SIRPα試薬を含む、項目93に記載の方法。
(項目96)
前記SIRPα試薬が、CD47に結合するSIRPαの一部を含む、項目95に記載の方法。
(項目97)
前記SIRPα試薬が、高親和性SIRPα試薬である、項目95又は96に記載の方法。
(項目98)
前記抗CD47剤が、CD47とSIRPαとの間の結合を阻害する単離された抗体を含む、項目93に記載の方法。
(項目99)
前記抗CD47剤が、抗CD47抗体又は抗SIRPα抗体を含む、項目98に記載の方法。
(項目100)
前記抗CD47剤が、マグロリマブ(Hu5F9-G4)を含む、項目98又は99のいずれか一項に記載の方法。
(項目101)
前記抗CD47剤が、Hu1H9-G1、Hu1H9-G4、Hu3C2-G1、Hu3C2-G4、9B11-G1、9B11-G4、7E11-G1、及び7E11-G4のうちの少なくとも1つを含む、項目98~100のいずれか一項に記載の方法。
(項目102)
前記対象が、以前に抗CD20療法剤で治療されており、前記対象への、CD47とSIRPαとの間の結合を阻害する抗CD47剤の投与及び抗CD20抗体の投与は、前記対象が以前に抗CD20療法剤で治療されてから28日後以降にそれぞれ実施される、項目93~101のいずれか一項に記載の方法。
(項目103)
前記抗CD47剤が、体重1kg当たり少なくとも10~30、20~30、10、15、20、又は30mgの用量で投与される、項目93~102のいずれか一項に記載の方法。
(項目104)
前記抗CD47剤が静脈内投与される、項目93~103のいずれか一項に記載の方法。
(項目105)
前記抗CD20抗体が静脈内投与される、項目93~104のいずれか一項に記載の方法。
(項目106)
CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、抗CD47抗体であり、前記抗CD47抗体は、体重1kg当たり少なくとも1mgの1日目のプライミング用量と、体重1kg当たり少なくとも30mgの8日目に開始する4週間の週間用量と、を含む、初回サイクルで前記対象に投与される、項目93~105のいずれか一項に記載の方法。
(項目107)
CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、体重1kg当たり少なくとも30mgの4週間の週間用量を含む、2回目のサイクルで前記対象に更に投与される、項目106に記載の方法。
(項目108)
CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、体重1kg当たり少なくとも30mgの隔週用量を含む、3回目のサイクルで前記対象に更に投与される、項目107に記載の方法。
(項目109)
CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、体重1kg当たり少なくとも30mgの隔週用量を含む、後続サイクルで前記対象に更に投与される、項目108に記載の方法。
(項目110)
前記後続サイクルが、限定することなく、又は臨床的利益が低減若しくは消滅するか、又は観察されなくなるまで、1回以上の追加のサイクルとして繰り返される、項目109に記載の方法。
(項目111)
前記初回サイクルが、体表面積1m 2 当たり375mgの週間用量の抗CD20抗体を更に含む、項目106~110のいずれか一項に記載の方法。
(項目112)
前記2回目のサイクルが、体表面積1m 2 当たり375mgの月間用量の抗CD20抗体を更に含む、項目107~111のいずれか一項に記載の方法。
(項目113)
前記3回目のサイクルが、体表面積1m 2 当たり375mgの月間用量の抗CD20抗体を更に含む、項目108~112のいずれか一項に記載の方法。
(項目114)
前記後続サイクルが、体表面積1m 2 当たり375mgの隔月用量の抗CD20抗体を更に含む、項目109~113のいずれか一項に記載の方法。
(項目115)
前記抗CD20抗体が、100、125、150、175、200、225、250、275、300、325、350、375、400、425、450、475、又は500mg/m 2 のいずれか1つの用量で前記対象に投与される、項目93~110のいずれか一項に記載の方法。
(項目116)
前記抗CD47剤及び前記抗CD20抗体が両方とも前記対象に投与される日に、前記抗CD47剤が、前記抗CD20抗体の前に前記対象に投与される、項目93~115のいずれか一項に記載の方法。
(項目117)
前記抗CD47剤及び前記抗CD20抗体が両方とも前記対象に投与される日に、前記抗CD20抗体が、抗CD47剤の前に前記対象に投与される、項目93~115のいずれか一項に記載の方法。
(項目118)
化学療法剤を前記対象に投与することを更に含む、項目68~117のいずれか一項に記載の方法。
(項目119)
前記化学療法剤が、ゲムシタビン、オキサリプラチン、又はゲムシタビンとオキサリプラチンの組み合わせ(GEMOX)である、項目118に記載の方法。
(項目120)
前記抗CD20抗体がリツキシマブを含む、項目93~119のいずれか一項に記載の方法。
(項目121)
前記抗CD20抗体が、配列番号131~136の配列を含む1つ、2つ、3つ、4つ、5つ、又は6つの相補性決定領域(CDR)を含む、項目93~120のいずれか一項に記載の方法。
(項目122)
前記抗CD20抗体が、配列番号137の可変重鎖配列を含む、項目93~121のいずれか一項に記載の方法。
(項目123)
前記抗CD20抗体が、配列番号142の可変軽鎖配列を含む、項目93~122のいずれか一項に記載の方法。
(項目124)
前記抗CD20抗体がFc領域を含み、前記Fc領域は、配列番号140のC H2 配列及び配列番号141のC H3 配列を含む、項目93~123のいずれか一項に記載の方法。
(項目125)
前記抗CD20抗体がFab又はscFvを含み、前記Fab又はscFvは、配列番号137の可変重鎖配列及び配列番号142の可変軽鎖配列を含む、項目93~124のいずれか一項に記載の方法。
(項目126)
前記抗CD20抗体がFab又はscFvを含み、前記Fab又はscFvは、配列番号131~136の配列を含む、項目93~125のいずれか一項に記載の方法。
(項目127)
前記血液癌が、B細胞血液悪性腫瘍である、項目1~126のいずれか一項に記載の方法。
(項目128)
前記血液癌が、CD20+癌である、項目127に記載の方法。
(項目129)
びまん性大細胞型B細胞リンパ腫(DLBCL)を有する対象を治療する方法であって、抗CD47抗体を静脈内に及び抗CD20抗体を、少なくとも3回の異なるサイクルで前記対象に投与することを含み、
前記初回サイクルは、(1)1日目に、体重1kg当たり1mg~10mgの抗体の範囲のプライミング用量の前記抗CD47抗体を投与することと、(2)8日目に開始して4週間、体重1kg当たり少なくとも30mgの週間用量の前記抗CD47抗体を投与することと、(2)体表面積1m 2 当たり375mgの週間用量の前記抗CD20抗体を投与することと、を含み、
前記2回目のサイクルは、(1)4週間、体重1kg当たり少なくとも30mgの週間用量の前記抗CD47抗体を投与することと、(2)体表面積1m 2 当たり375mgの月間用量の前記抗CD20抗体を投与することと、を含み、
前記3回目のサイクルは、(1)体重1kg当たり少なくとも30mgの隔週用量の前記抗CD47抗体を投与することと、(2)体表面積1m 2 当たり375mgの月間用量の前記抗CD20抗体を投与することと、を含む、方法。
(項目130)
びまん性大細胞型B細胞リンパ腫(DLBCL)を有する対象を治療する方法であって、抗CD47抗体を静脈内に及び抗CD20抗体を、少なくとも3回の異なるサイクルで前記対象に投与することを含み、
前記初回サイクルは、(1)1日目に、80mg~800mgの範囲のプライミング用量の前記抗CD47抗体を投与することと、(2)8日目に開始して4週間、少なくとも2400mgの週間用量の前記抗CD47抗体を投与することと、(2)体表面積1m 2 当たり375mgの週間用量の前記抗CD20抗体を投与することと、を含み、
前記2回目のサイクルは、(1)4週間、少なくとも2400mgの週間用量の前記抗CD47抗体を投与することと、(2)体表面積1m 2 当たり375mgの月間用量の前記抗CD20抗体を投与することと、を含み、
前記3回目のサイクルは、(1)少なくとも2400mgの隔週用量の前記抗CD47抗体を投与することと、(2)体表面積1m 2 当たり375mgの月間用量の前記抗CD20抗体を投与することと、を含む、方法。
(項目131)
前記抗CD47抗体がマグロリマブを含む、項目129又は130に記載の方法。
(項目132)
前記抗CD20抗体がリツキシマブを含む、項目129~131のいずれか一項に記載の方法。
(項目133)
前記抗CD20抗体が静脈内投与される、項目129~132のいずれか一項に記載の方法。
Claims (133)
- 対象における血液癌の治療方法であって、(a)CD47とSIRPαとの間の結合を阻害する抗CD47剤を投与することと、(b)抗CD20抗体を前記対象に投与することと、を含み、工程(a)及び(b)を実施する前に、B細胞が前記対象に存在していることが決定されるか、又は決定されている、方法。
- 対象における血液癌の治療方法であって、
B細胞が前記対象に存在することを決定すること又は決定されていることと、
(i)CD47とSIRPαとの間の結合を阻害する抗CD47剤、及び(ii)抗CD20抗体を、前記対象に投与すること又は投与されていることと、を含む、方法。 - B細胞が前記対象に存在することの前記決定が、フローサイトメトリー、B細胞耐性パネル、ELISA、免疫組織化学的顕微鏡検査、RNAプロファイリング、RNA配列決定、RNAアレイ系検出、RT-PCR、ノーザンブロット、免疫グロブリン配列決定、ウエスタンブロット、酵素結合免疫スポット、又は免疫蛍光顕微鏡検査から選択される少なくとも1つのアッセイを実施すること又は実施されていることを含む、請求項1~2のいずれか一項に記載の方法。
- 前記抗CD47剤及び前記抗CD20抗体を前記対象に投与する前に、B細胞が前記対象に存在することの前記決定を前提として、前記対象を治療の候補者であると決定することを更に含む、請求項1~3のいずれか一項に記載の方法。
- B細胞が前記対象に存在することの前記決定は、前記対象がCD19+B細胞を有すると決定すること又は決定されていることを含む、請求項1~4のいずれか一項に記載の方法。
- 前記対象がCD19+B細胞を有すると決定すること又は決定されていることは、前記対象がCD19+B細胞を閾値量を超えて有すると決定すること又は決定されていることを含む、請求項5に記載の方法。
- CD19+B細胞の前記閾値量が、CD19+B細胞の存在を決定するために使用されるアッセイの検出限界である、請求項6に記載の方法。
- CD19+B細胞の前記閾値量が、リンパ球の総集団のうち少なくとも5パーセントのCD19+B細胞である、請求項6に記載の方法。
- CD19+B細胞の前記閾値量が、マイクロリットル当たり少なくとも1個のCD19+B細胞である、請求項6に記載の方法。
- CD19+B細胞の前記閾値量が、マイクロリットル当たり少なくとも40個のCD19+B細胞である、請求項6に記載の方法。
- B細胞が前記対象に存在することの前記決定は、前記対象がCD20+B細胞を有すると決定すること又は決定されていることを含む、請求項1~4のいずれか一項に記載の方法。
- 前記対象がCD20+B細胞を有すると決定すること又は決定されていることは、前記対象がCD20+B細胞を閾値量を超えて有すると決定すること又は決定されていることを含む、請求項11に記載の方法。
- CD20+B細胞の前記閾値量が、CD20+B細胞の存在を決定するために使用されるアッセイの検出限界である、請求項11に記載の方法。
- CD20+B細胞の前記閾値量が、リンパ球の総集団のうち少なくとも5パーセントのCD20+B細胞である、請求項11に記載の方法。
- CD20+B細胞の前記閾値量が、マイクロリットル当たり少なくとも1個のCD20+B細胞である、請求項11に記載の方法。
- CD20+B細胞の前記閾値量が、マイクロリットル当たり少なくとも40個のCD20+B細胞である、請求項11に記載の方法。
- B細胞が前記対象に存在することの前記決定は、前記対象がCD19+B細胞及びCD20+B細胞の両方を有すると決定すること又は決定されていることを含む、請求項1~4のいずれか一項に記載の方法。
- 前記対象がCD19+B細胞及びCD20+B細胞の両方を有すると決定すること又は決定されていることは、前記対象がCD19+B細胞及びCD20+B細胞を閾値量を超えて有すると決定すること又は決定されていることを含む、請求項17に記載の方法。
- CD19+B細胞の前記閾値量が、CD19+B細胞の存在を決定するために使用されるアッセイの検出限界、リンパ球の総集団のうち少なくとも5パーセントのCD19+B細胞、マイクロリットル当たり少なくとも1個のCD19+B細胞、又はマイクロリットル当たり少なくとも40個のCD19+B細胞のうち、いずれか1つである、請求項18に記載の方法。
- CD20+B細胞の前記閾値量が、CD20+B細胞の存在を決定するために使用されるアッセイの検出限界、リンパ球の総集団のうち少なくとも5パーセントのCD20+B細胞、マイクロリットル当たり少なくとも1個のCD20+B細胞、又はマイクロリットル当たり少なくとも40個のCD20+B細胞のうち、いずれか1つである、請求項18又は19に記載の方法。
- B細胞が前記対象に存在することの前記決定は、前記対象が閾値期間を超えて以前に抗CD20療法剤を投与されたことを決定すること又は決定されていることを含む、請求項1~20のいずれか一項に記載の方法。
- 前記閾値期間が、少なくとも4週間である、請求項21に記載の方法。
- 前記閾値期間が、少なくとも5、6、7、8、9、10、11、12、13、14、15、16、17、18、19、20、21、22、23、24、25、26、27、又は28週間である、請求項21に記載の方法。
- B細胞が前記対象に存在することの前記決定は、前記対象において抗CD20療法剤が存在していないことを決定すること又は決定されていることを含む、請求項1~23のいずれか一項に記載の方法。
- 前記対象において前記抗CD20療法剤が存在していないことを決定すること又は決定されていることは、前記対象が抗CD20療法剤の閾値濃度を下回って有していることを決定すること又は決定されていることを含む、請求項24に記載の方法。
- 前記抗CD20療法剤の前記閾値濃度が、抗CD20療法剤の存在を検出するために使用される検出アッセイの定量限界である、請求項25に記載の方法。
- 前記抗CD20療法剤の存在を検出するために使用される前記検出アッセイが、イムノアッセイ、ELIspot、フルオロスポット、フローサイトメトリー系アッセイ、ウエスタンブロット、LC質量分析、又は表面プラズモン共鳴のうちの1つである、請求項26に記載の方法。
- 以前に投与された抗CD20療法剤がリツキシマブを含む、請求項21~27のいずれか一項に記載の方法。
- B細胞が、前記対象から得られたサンプルを使用して、前記対象に存在すると決定されるか又は決定されている、請求項1~28のいずれか一項に記載の方法。
- 前記対象から得られた前記サンプルが、末梢血サンプルである、請求項29に記載の方法。
- 前記抗CD47剤が、CD47とSIRPαとの間の結合を阻害する単離された抗体を含む、請求項1~30のいずれか一項に記載の方法。
- 前記抗CD47剤が、SIRPα試薬を含む、請求項1~31のいずれか一項に記載の方法。
- 前記SIRPα試薬が、CD47に結合するSIRPαの一部を含む、請求項32に記載の方法。
- 前記SIRPα試薬が、高親和性SIRPα試薬である、請求項32又は33に記載の方法。
- 前記抗CD47剤が、抗CD47抗体又は抗SIRPα抗体を含む、請求項1~34のいずれか一項に記載の方法。
- 前記抗CD47剤が、マグロリマブ(Hu5F9-G4)を含む、請求項1~35のいずれか一項に記載の方法。
- 前記抗CD47剤が、Hu1H9-G1、Hu1H9-G4、Hu3C2-G1、Hu3C2-G4、9B11-G1、9B11-G4、7E11-G1、及び7E11-G4のうちの少なくとも1つを含む、請求項1~36のいずれか一項に記載の方法。
- 前記血液癌が、びまん性大細胞型B細胞リンパ腫(DLBCL)である、請求項1~37のいずれか一項に記載の方法。
- 前記対象が、再発性又は難治性DLBCLを有する、請求項1~38のいずれか一項に記載の方法。
- 前記対象が、以前に少なくとも2種類の治療法で治療されている、請求項39に記載の方法。
- 前記血液癌が、濾胞性リンパ腫(FL)である、請求項1~37のいずれか一項に記載の方法。
- 前記血液癌が、非ホジキンリンパ腫、辺縁帯リンパ腫、マントル細胞リンパ腫、慢性リンパ性白血病/小リンパ性白血病、ワルデンストレームマクログロブリン血症/リンパ形質細胞性リンパ腫、縦隔原発B細胞リンパ腫、バーキットリンパ腫、B細胞リンパ腫未分類型、B細胞急性リンパ芽球性白血病、又は移植後リンパ増殖性疾患(PTLD)のうちの1つである、請求項1~37のいずれか一項に記載の方法。
- 前記抗CD47剤が、体重1kg当たり少なくとも10~30、20~30、10、15、20、又は30mgの用量で投与される、請求項1~42のいずれか一項に記載の方法。
- 前記抗CD47剤が静脈内投与される、請求項1~43のいずれか一項に記載の方法。
- 前記抗CD20抗体が静脈内投与される、請求項1~44のいずれか一項に記載の方法。
- CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、抗CD47抗体であり、前記抗CD47抗体は、体重1kg当たり少なくとも1mg抗体の1日目のプライミング用量と、体重1kg当たり少なくとも30mgの8日目に開始する4週間の週間用量と、を含む、初回サイクルで前記対象に投与される、請求項1~45のいずれか一項に記載の方法。
- CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、体重1kg当たり少なくとも30mgの4週間の週間用量を含む、2回目のサイクルで前記対象に更に投与される、請求項46に記載の方法。
- CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、体重1kg当たり少なくとも30mgの隔週用量を含む、3回目のサイクルで前記対象に更に投与される、請求項47に記載の方法。
- CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、体重1kg当たり少なくとも30mgの隔週用量を含む、後続サイクルで前記対象に更に投与される、請求項48に記載の方法。
- 前記後続サイクルが、限定することなく、又は臨床的利益が低減若しくは消滅するか、又は観察されなくなるまで、1回以上の追加のサイクルとして繰り返される、請求項49に記載の方法。
- 前記初回サイクルが、体表面積1m2当たり375mgの週間用量の抗CD20抗体を更に含む、請求項46~50のいずれか一項に記載の方法。
- 前記2回目のサイクルが、体表面積1m2当たり375mgの月間用量の抗CD20抗体を更に含む、請求項47~51のいずれか一項に記載の方法。
- 前記3回目のサイクルが、体表面積1m2当たり375mgの月間用量の抗CD20抗体を更に含む、請求項48~52のいずれか一項に記載の方法。
- 前記後続サイクルが、体表面積1m2当たり375mgの隔月用量の抗CD20抗体を更に含む、請求項49~53のいずれか一項に記載の方法。
- 前記抗CD20抗体が、100、125、150、175、200、225、250、275、300、325、350、375、400、425、450、475、又は500mg/m2のいずれか1つの用量で前記対象に投与される、請求項1~50のいずれか一項に記載の方法。
- 前記抗CD47剤及び前記抗CD20抗体が両方とも前記対象に投与される日に、前記抗CD47剤が、前記抗CD20抗体の前に前記対象に投与される、請求項1~55のいずれか一項に記載の方法。
- 前記抗CD47剤及び前記抗CD20抗体が両方とも前記対象に投与される日に、前記抗CD20抗体が、前記抗CD47剤の前に対象に投与される、請求項1~55のいずれか一項に記載の方法。
- 化学療法剤を前記対象に投与することを更に含む、請求項1~57のいずれか一項に記載の方法。
- 前記化学療法剤が、ゲムシタビン、オキサリプラチン、又はゲムシタビンとオキサリプラチンの組み合わせ(GEMOX)である、請求項58に記載の方法。
- 前記抗CD20抗体がリツキシマブを含む、請求項1~59のいずれか一項に記載の方法。
- 前記抗CD20抗体が、配列番号131~136の配列を含む1つ、2つ、3つ、4つ、5つ、又は6つの相補性決定領域(CDR)を含む、請求項1~60のいずれか一項に記載の方法。
- 前記抗CD20抗体が、配列番号137の可変重鎖配列を含む、請求項1~61のいずれか一項に記載の方法。
- 前記抗CD20抗体が、配列番号142の可変軽鎖配列を含む、請求項1~62のいずれか一項に記載の方法。
- 前記抗CD20抗体がFc領域を含み、前記Fc領域は、配列番号140のCH2配列及び配列番号141のCH3配列を含む、請求項1~63のいずれか一項に記載の方法。
- 前記抗CD20抗体がFab又はscFvを含み、前記Fab又はscFvは、配列番号137の可変重鎖配列及び配列番号142の可変軽鎖配列を含む、請求項1~64のいずれか一項に記載の方法。
- 前記抗CD20抗体がFab又はscFvを含み、前記Fab又はscFvは、配列番号131~136の配列を含む、請求項1~65のいずれか一項に記載の方法。
- 対象における血液癌の治療方法であって、前記方法は、
B細胞が前記対象に存在することを決定すること又は決定されていることであって、前記決定は、前記対象が、リンパ球の総量のうち少なくとも5パーセントのCD19+B細胞を有すると決定すること又は決定されていることを含む、ことと、
マグロリマブを投与すること;と、
前記対象にリツキシマブを投与することと、を含み、
前記対象は、以前に少なくとも2種類の治療法で治療されているヒト対象であり、
前記血液癌は、再発性又は難治性DLBCLであり、
マグロリマブを投与することは、(1)1日目に、体重1kg当たり1mg~10mg(例えば、1mg~5mg、例えば、1mg、2mg、3mg、4mg、5mg)の抗体の範囲のプライミング用量のマグロリマブを投与することと、(2)体重1kg当たり30mgで週間用量のマグロリマブを8週間投与することと、(3)以降体重1kg当たり30mgで隔週用量のマグロリマブを投与することと、を含み、
リツキシマブを投与することは、(1)体表面積1m2当たり375mgで週間用量のリツキシマブを4週間投与することと、その後、(2)体表面積1m2当たり375mgで毎月リツキシマブを投与することと、を含む、方法。 - 方法であって、
対象が直近に閾値期間を超えて以前に抗CD20療法剤を投与されたかどうかに基づいて、B細胞が血液癌を有する前記対象に存在するかどうかを決定することであって、前記対象が直近に閾値期間を超えて以前に抗CD20療法剤を投与されていることは、B細胞が前記対象に存在することを示す、ことを含み、
前記対象におけるB細胞の存在は、前記対象が、1)CD47とSIRPαとの間の結合を阻害する抗CD47剤と、2)リツキシマブと、を含む、治療に応答する可能性が高いことを示し、
前記対象におけるB細胞の非存在は、前記対象が、1)CD47とSIRPαとの間の結合を阻害する抗CD47剤と、2)リツキシマブと、を含む、治療に応答する可能性が低いことを示す、方法。 - 方法であって、
血液癌を有する対象からサンプルを得ることと、
前記対象から得られたサンプルでアッセイを実施することによってB細胞が存在するかどうかを決定することと、を含み、
前記対象におけるB細胞の存在は、前記対象が、1)CD47とSIRPαとの間の結合を阻害する抗CD47剤と、2)リツキシマブと、を含む、治療に応答する可能性が高いことを示し、
前記対象におけるB細胞の非存在は、前記対象が、1)CD47とSIRPαとの間の結合を阻害する抗CD47剤と、2)リツキシマブと、を含む、治療に応答する可能性が低いことを示す、方法。 - 前記対象から得られた前記サンプルが、末梢血サンプルである、請求項69に記載の方法。
- 方法であって、
血液癌を有する対象におけるB細胞の存在を示す情報を含むデータセットを取得すること又は取得されていることであって、前記血液癌を有する対象におけるB細胞の存在を示す前記情報は、
前記対象におけるB細胞の量、
前記対象における全リンパ球中のB細胞の割合、
前記対象が直近に抗CD20療法剤を投与された日数、
前記対象における抗CD20療法剤の存在又は非存在、のうちの1つを含む、ことと、
前記データセットを使用して、B細胞が前記血液癌を有する対象に存在することを決定することと、
前記血液癌を有する対象に治療を施すことと、を含む、方法。 - 前記データセットを取得すること又は取得されていることは、フローサイトメトリー、B細胞耐性パネル、ELISA、免疫組織化学的顕微鏡検査、RNAプロファイリング、RNA配列決定、RNAアレイ系検出、RT-PCR、ノーザンブロット、免疫グロブリン配列決定、ウエスタンブロット、ELIspot、又は免疫蛍光顕微鏡検査から選択される少なくとも1つのアッセイを実施すること又は実施されていることを含む、請求項71に記載の方法。
- 前記データセット内の前記情報は、前記対象から得られたサンプル中のB細胞の量、又は前記対象から得られたサンプル中のB細胞の割合のうちのいずれか1つを含み、B細胞が前記対象に存在することを決定することは、前記情報を、B細胞の閾値量と比較することを含む、請求項71又は72に記載の方法。
- B細胞の前記閾値量が、リンパ球の総集団のうち少なくとも5パーセントのB細胞である、請求項73に記載の方法。
- B細胞の前記閾値量が、少なくとも、B細胞の存在を決定するために使用されるアッセイの検出限界である、請求項73に記載の方法。
- B細胞の前記閾値量が、マイクロリットル当たり少なくとも1個のB細胞である、請求項73に記載の方法。
- B細胞の前記閾値量が、マイクロリットル当たり少なくとも40個のB細胞である、請求項73に記載の方法。
- 前記B細胞が、CD19+B細胞又はCD20+B細胞のうちの1つである、請求項71~77のいずれか一項に記載の方法。
- 前記B細胞が、CD19+B細胞及びCD20+B細胞の両方である、請求項71~77のいずれか一項に記載の方法。
- 前記データセット内の前記情報は、前記対象が以前に抗CD20療法剤を投与された期間を含み、B細胞が前記対象に存在することを決定することは、前記対象が以前に抗CD20療法剤を投与された前記期間が閾値期間を超えるかどうかを決定することを含む、請求項71~79のいずれか一項に記載の方法。
- 前記閾値期間が、少なくとも4週間である、請求項80に記載の方法。
- 前記閾値期間が、少なくとも5、6、7、8、9、10、11、12、13、14、15、16、17、18、19、20、21、22、23、24、25、26、27、又は28週間である、請求項80に記載の方法。
- 前記データセット内の前記情報は、前記対象における抗CD20療法剤の存在又は非存在を含み、B細胞が前記対象に存在することを決定することは、前記対象において抗CD20療法剤が存在していないことを決定することを含む、請求項71~82のいずれか一項に記載の方法。
- 前記対象における抗CD20療法剤が存在していないことを決定することは、前記対象が前記抗CD20療法剤の閾値濃度を下回って有することを決定すること又は決定されていることを含む、請求項83に記載の方法。
- 前記抗CD20療法剤の前記閾値濃度が、抗CD20療法剤の存在を検出するために使用される検出アッセイの定量限界である、請求項84に記載の方法。
- 前記抗CD20療法剤の存在を検出するために使用される前記検出アッセイが、イムノアッセイ、酵素結合免疫スポット、フルオロスポット、フローサイトメトリー系アッセイ、ウエスタンブロット、LC質量分析、又は表面プラズモン共鳴のうちの1つである、請求項85に記載の方法。
- 以前に投与された抗CD20療法剤がリツキシマブを含む、請求項80~86のいずれか一項に記載の方法。
- 前記血液癌が、びまん性大細胞型B細胞リンパ腫(DLBCL)である、請求項68~87のいずれか一項に記載の方法。
- 前記血液癌が、再発性又は難治性DLBCLである、請求項68~87のいずれか一項に記載の方法。
- 前記対象が、以前に少なくとも2種類の治療法で治療されている、請求項68~89のいずれか一項に記載の方法。
- 前記血液癌が、濾胞性リンパ腫(FL)である、請求項68~87のいずれか一項に記載の方法。
- 前記血液癌が、非ホジキンリンパ腫、辺縁帯リンパ腫、マントル細胞リンパ腫、慢性リンパ性白血病/小リンパ性白血病、ワルデンストレームマクログロブリン血症/リンパ形質細胞性リンパ腫、縦隔原発B細胞リンパ腫、バーキットリンパ腫、B細胞リンパ腫未分類型、B細胞急性リンパ芽球性白血病、又は移植後リンパ増殖性疾患(PTLD)のうちの1つである、請求項68~87のいずれか一項に記載の方法。
- 前記治療を施すことが、CD47とSIRPα,との間の結合を阻害する抗CD47剤を投与することと、前記対象に抗CD20抗体を投与することと、を含む、請求項71~92のいずれか一項に記載の方法。
- 前記抗CD47剤が、CD47とSIRPαとの間の結合を阻害する単離された抗体を含む、請求項93に記載の方法。
- 前記抗CD47剤が、SIRPα試薬を含む、請求項93に記載の方法。
- 前記SIRPα試薬が、CD47に結合するSIRPαの一部を含む、請求項95に記載の方法。
- 前記SIRPα試薬が、高親和性SIRPα試薬である、請求項95又は96に記載の方法。
- 前記抗CD47剤が、CD47とSIRPαとの間の結合を阻害する単離された抗体を含む、請求項93に記載の方法。
- 前記抗CD47剤が、抗CD47抗体又は抗SIRPα抗体を含む、請求項98に記載の方法。
- 前記抗CD47剤が、マグロリマブ(Hu5F9-G4)を含む、請求項98又は99のいずれか一項に記載の方法。
- 前記抗CD47剤が、Hu1H9-G1、Hu1H9-G4、Hu3C2-G1、Hu3C2-G4、9B11-G1、9B11-G4、7E11-G1、及び7E11-G4のうちの少なくとも1つを含む、請求項98~100のいずれか一項に記載の方法。
- 前記対象が、以前に抗CD20療法剤で治療されており、前記対象への、CD47とSIRPαとの間の結合を阻害する抗CD47剤の投与及び抗CD20抗体の投与は、前記対象が以前に抗CD20療法剤で治療されてから28日後以降にそれぞれ実施される、請求項93~101のいずれか一項に記載の方法。
- 前記抗CD47剤が、体重1kg当たり少なくとも10~30、20~30、10、15、20、又は30mgの用量で投与される、請求項93~102のいずれか一項に記載の方法。
- 前記抗CD47剤が静脈内投与される、請求項93~103のいずれか一項に記載の方法。
- 前記抗CD20抗体が静脈内投与される、請求項93~104のいずれか一項に記載の方法。
- CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、抗CD47抗体であり、前記抗CD47抗体は、体重1kg当たり少なくとも1mgの1日目のプライミング用量と、体重1kg当たり少なくとも30mgの8日目に開始する4週間の週間用量と、を含む、初回サイクルで前記対象に投与される、請求項93~105のいずれか一項に記載の方法。
- CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、体重1kg当たり少なくとも30mgの4週間の週間用量を含む、2回目のサイクルで前記対象に更に投与される、請求項106に記載の方法。
- CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、体重1kg当たり少なくとも30mgの隔週用量を含む、3回目のサイクルで前記対象に更に投与される、請求項107に記載の方法。
- CD47とSIRPαとの間の結合を阻害する前記抗CD47剤は、体重1kg当たり少なくとも30mgの隔週用量を含む、後続サイクルで前記対象に更に投与される、請求項108に記載の方法。
- 前記後続サイクルが、限定することなく、又は臨床的利益が低減若しくは消滅するか、又は観察されなくなるまで、1回以上の追加のサイクルとして繰り返される、請求項109に記載の方法。
- 前記初回サイクルが、体表面積1m2当たり375mgの週間用量の抗CD20抗体を更に含む、請求項106~110のいずれか一項に記載の方法。
- 前記2回目のサイクルが、体表面積1m2当たり375mgの月間用量の抗CD20抗体を更に含む、請求項107~111のいずれか一項に記載の方法。
- 前記3回目のサイクルが、体表面積1m2当たり375mgの月間用量の抗CD20抗体を更に含む、請求項108~112のいずれか一項に記載の方法。
- 前記後続サイクルが、体表面積1m2当たり375mgの隔月用量の抗CD20抗体を更に含む、請求項109~113のいずれか一項に記載の方法。
- 前記抗CD20抗体が、100、125、150、175、200、225、250、275、300、325、350、375、400、425、450、475、又は500mg/m2のいずれか1つの用量で前記対象に投与される、請求項93~110のいずれか一項に記載の方法。
- 前記抗CD47剤及び前記抗CD20抗体が両方とも前記対象に投与される日に、前記抗CD47剤が、前記抗CD20抗体の前に前記対象に投与される、請求項93~115のいずれか一項に記載の方法。
- 前記抗CD47剤及び前記抗CD20抗体が両方とも前記対象に投与される日に、前記抗CD20抗体が、抗CD47剤の前に前記対象に投与される、請求項93~115のいずれか一項に記載の方法。
- 化学療法剤を前記対象に投与することを更に含む、請求項68~117のいずれか一項に記載の方法。
- 前記化学療法剤が、ゲムシタビン、オキサリプラチン、又はゲムシタビンとオキサリプラチンの組み合わせ(GEMOX)である、請求項118に記載の方法。
- 前記抗CD20抗体がリツキシマブを含む、請求項93~119のいずれか一項に記載の方法。
- 前記抗CD20抗体が、配列番号131~136の配列を含む1つ、2つ、3つ、4つ、5つ、又は6つの相補性決定領域(CDR)を含む、請求項93~120のいずれか一項に記載の方法。
- 前記抗CD20抗体が、配列番号137の可変重鎖配列を含む、請求項93~121のいずれか一項に記載の方法。
- 前記抗CD20抗体が、配列番号142の可変軽鎖配列を含む、請求項93~122のいずれか一項に記載の方法。
- 前記抗CD20抗体がFc領域を含み、前記Fc領域は、配列番号140のCH2配列及び配列番号141のCH3配列を含む、請求項93~123のいずれか一項に記載の方法。
- 前記抗CD20抗体がFab又はscFvを含み、前記Fab又はscFvは、配列番号137の可変重鎖配列及び配列番号142の可変軽鎖配列を含む、請求項93~124のいずれか一項に記載の方法。
- 前記抗CD20抗体がFab又はscFvを含み、前記Fab又はscFvは、配列番号131~136の配列を含む、請求項93~125のいずれか一項に記載の方法。
- 前記血液癌が、B細胞血液悪性腫瘍である、請求項1~126のいずれか一項に記載の方法。
- 前記血液癌が、CD20+癌である、請求項127に記載の方法。
- びまん性大細胞型B細胞リンパ腫(DLBCL)を有する対象を治療する方法であって、抗CD47抗体を静脈内に及び抗CD20抗体を、少なくとも3回の異なるサイクルで前記対象に投与することを含み、
前記初回サイクルは、(1)1日目に、体重1kg当たり1mg~10mgの抗体の範囲のプライミング用量の前記抗CD47抗体を投与することと、(2)8日目に開始して4週間、体重1kg当たり少なくとも30mgの週間用量の前記抗CD47抗体を投与することと、(2)体表面積1m2当たり375mgの週間用量の前記抗CD20抗体を投与することと、を含み、
前記2回目のサイクルは、(1)4週間、体重1kg当たり少なくとも30mgの週間用量の前記抗CD47抗体を投与することと、(2)体表面積1m2当たり375mgの月間用量の前記抗CD20抗体を投与することと、を含み、
前記3回目のサイクルは、(1)体重1kg当たり少なくとも30mgの隔週用量の前記抗CD47抗体を投与することと、(2)体表面積1m2当たり375mgの月間用量の前記抗CD20抗体を投与することと、を含む、方法。 - びまん性大細胞型B細胞リンパ腫(DLBCL)を有する対象を治療する方法であって、抗CD47抗体を静脈内に及び抗CD20抗体を、少なくとも3回の異なるサイクルで前記対象に投与することを含み、
前記初回サイクルは、(1)1日目に、80mg~800mgの範囲のプライミング用量の前記抗CD47抗体を投与することと、(2)8日目に開始して4週間、少なくとも2400mgの週間用量の前記抗CD47抗体を投与することと、(2)体表面積1m2当たり375mgの週間用量の前記抗CD20抗体を投与することと、を含み、
前記2回目のサイクルは、(1)4週間、少なくとも2400mgの週間用量の前記抗CD47抗体を投与することと、(2)体表面積1m2当たり375mgの月間用量の前記抗CD20抗体を投与することと、を含み、
前記3回目のサイクルは、(1)少なくとも2400mgの隔週用量の前記抗CD47抗体を投与することと、(2)体表面積1m2当たり375mgの月間用量の前記抗CD20抗体を投与することと、を含む、方法。 - 前記抗CD47抗体がマグロリマブを含む、請求項129又は130に記載の方法。
- 前記抗CD20抗体がリツキシマブを含む、請求項129~131のいずれか一項に記載の方法。
- 前記抗CD20抗体が静脈内投与される、請求項129~132のいずれか一項に記載の方法。
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