Epratuzumab Y-90(Epratuzumab Y-90) - 药物靶点：CD22_专利_临床

概要

基本信息

药物类型

抗体偶联核素、治疗用放射药物

别名

90Y-Epratuzumab、Anti-CD22 monoclonal antibody LL2-Y-90、Monoclonal antibody LL2-Y-90

+ [9]

靶点

CD22

作用机制

CD22抑制剂(CD22抑制剂)

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [1]

在研适应症-

非在研适应症

侵袭性 B 细胞非霍奇金淋巴瘤B细胞淋巴瘤CD22阳性B细胞急性淋巴细胞白血病+ [5]

原研机构

Immunomedics, Inc.

在研机构-

非在研机构

Gilead Sciences, Inc.

Nantes University Hospital

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

使用我们的ADC技术数据为新药研发加速。

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序列信息

Sequence Code 146718

Sequence Code 9620786

关联

8

项与 Epratuzumab Y-90 相关的临床试验

NCT01354457 / Unknown status临床1/2期IIT

Evaluation of the Efficacy and Tolerance of Fractionated Radio-immunotherapy With 90Y-Epratuzumab (90Y-hLL2) for Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukaemia Patients

The purpose of this study is to determine whether fractionated RIT with Epratuzumab and radiolabeled Epratuzumab are effective in the treatment of relapsing or refractory ALL.

开始日期2010-11-01

申办/合作机构

Nantes University Hospital

NCT01147393 / Terminated临床1/2期IIT

Phase I/II Study of Combination Veltuzumab (Anti-CD20) and Fractionated 90Y- Epratuzumab (Anti-CD22) Radioimmunotherapy in Patients With Follicular Lymphoma

A Phase I/II clinical trial using a fractionated dosing regimen of 90Y-epratuzumab (anti-CD22) has showed encouraging responses in follicular and aggressive NHL with an ability to administer safely 2 injections of 20 mCi/m2 spaced 1 week apart. The investigators propose to combine this active 90Y-epratuzumab treatment with a regimen of veltuzumab that was also found active in Phase I/II trials.
The goal of this study is to determine the safety and efficacy of 90Y-epratuzumab when used in combination with veltuzumab. The primary objective is to determine the response rate of this combination treatment. Secondary objectives are to assess safety, pharmacokinetics and targeting of 90Y-epratuzumab . Veltuzumab blood levels and anti-antibody responses will also be monitored at various times.

开始日期2010-10-01

申办/合作机构

Weill Medical College of Cornell University

[+1]

NCT01101581 / Withdrawn临床1/2期

Phase I/II Study of Veltuzumab Combined With 90Y-Epratuzumab Tetraxetan in Patients With Relapsed/Refractory, Aggressive Non- Hodgkin's Lymphoma

The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab attack different areas on lymphoma cells. Because of this, treatment with the combination may provide more effective treatment in NHL than either veltuzumab or 90Y-epratuzumab given alone.

开始日期2010-05-01

申办/合作机构

Gilead Sciences, Inc.

100 项与 Epratuzumab Y-90 相关的临床结果

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100 项与 Epratuzumab Y-90 相关的转化医学

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100 项与 Epratuzumab Y-90 相关的专利（医药）

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20

项与 Epratuzumab Y-90 相关的文献（医药）

2017-01-01·The Lancet Haematology1区 · 医学

Consolidation anti-CD22 fractionated radioimmunotherapy with 90 Y-epratuzumab tetraxetan following R-CHOP in elderly patients with diffuse large B-cell lymphoma: a prospective, single group, phase 2 trial

1区 · 医学

Article

作者: Sadot, Sophie ; Bodet-Milin, Caroline ; Gressin, Remy ; Wegener, William A ; Deau, Bénédicte ; Goldenberg, David M ; Vuillez, Jean-Philippe ; Pallardy, Amandine ; Jardel, Henry ; Berthou, Christian ; Soubeyran, Pierre ; Bouabdallah, Krimo ; Moreau, Anne ; Gouilleux-Gruart, Valérie ; Barbet, Jacques ; Kraeber-Bodere, Françoise ; Le Gouill, Steven ; Tournilhac, Olivier ; Moles, Marie-Pierre ; Cazeau, Anne-Laure ; Campion, Loïc ; Gyan, Emmanuel ; Maisonneuve, Hervé ; Morineau, Nadine ; Lamy, Thierry ; Salaun, Pierre-Yves ; Soubeyran, Isabelle ; Moreau, Philippe ; Daguindau, Etienne ; Garin, Etienne

BACKGROUNDRadioimmunotherapy represents a potential option as consolidation after chemoimmunotherapy in patients with diffuse large B-cell lymphoma who are not candidates for transplantation. We aimed to assess activity and toxicity of fractionated radioimmunotherapy using anti-CD22 ⁹⁰Y-epratuzumab tetraxetan as consolidation after front-line induction chemoimmunotherapy in untreated elderly patients with diffuse large B-cell lymphoma.METHODSWe did a prospective, single-group, phase 2 trial at 28 hospitals in France, with patients recruited from 17 hospitals. Eligible patients were aged 60-80 years with bulky stage 2-3 or stage 3-4 CD20-positive diffuse large B-cell lymphoma, previously untreated, and not eligible for transplantation. Patients received six cycles of R-CHOP (rituximab [375 mg/m²], cyclophosphamide [750 mg/m²], doxorubicin [50 mg/m²], and vincristine [1·4 mg/m², up to 2 mg] all on day 1, and prednisone [40 mg/m²] daily for 5 days), administered every 14 days. 6-8 weeks after R-CHOP, responders received two doses of 15 mCi/m² (555 MBq/m²) ⁹⁰Y-epratuzumab tetraxetan administered 1 week apart. The primary endpoint was 2 year event-free survival in all registered eligible patients who received at least 1 day of study treatment; the safety analysis was done in the same population. This trial is registered with ClinicalTrials.gov, number NCT00906841.FINDINGSBetween Oct 22, 2008, and Dec 16, 2010, we recruited 75 patients, of whom four (5%) were excluded after central pathology review; hence, 71 (95%) patients were included in the analysis. All patients started induction treatment; 57 (80%) received radioimmunotherapy. With a median follow-up of 37 months (IQR 30-44), the estimated 2 year event-free survival was 75% (95% CI 63-84). Radioimmunotherapy toxicity consisted of grade 3-4 thrombocytopenia in 48 (84%) of 57 patients and neutropenia in 45 (79%) of 57 patients. One patient developed myelodysplastic syndrome 28 months after receiving radioimmunotherapy and one patient developed acute myeloid leukaemia 5 months after receiving radioimmunotherapy.INTERPRETATIONFractionated radioimmunotherapy with ⁹⁰Y-epratuzumab tetraxetan might be appropriate for response consolidation after induction chemotherapy in older patients with advanced diffuse large B-cell lymphoma, but further comparative studies are needed.FUNDINGImmunomedics, Amgen, Canceropôle Grand Ouest, the GOELAMS/LYSA group and the French National Agency for Research (Investissements d'Avenir).

2015-03-01·The Lancet Haematology1区 · 医学

90 Y-labelled anti-CD22 epratuzumab tetraxetan in adults with refractory or relapsed CD22-positive B-cell acute lymphoblastic leukaemia: a phase 1 dose-escalation study

1区 · 医学

Article

作者: Alain Faivre-Chauvet ; Jacques Delaunay ; Claire Le Houerou ; Pierre Peterlin ; Simona Lapusan ; Françoise Huguet ; Mathilde Hunault ; Antoine Marcais ; William A Wegener ; Marion Eveillard ; Françoise Kraeber-Bodéré ; Marie C Bene ; Thierry Guillaume ; Michel Cherel ; Patrice Chevallier ; Norbert Ifrah ; Nelly Robillard ; Xavier Thomas ; Caroline Bodet-Milin ; Franck Nicolini ; Ludovic Ferrer ; Jacques Barbet ; Martine Escoffre-Barbe ; Joelle Gaschet ; David M Goldenberg ; Thomas Eugene ; Françoise Isnard

BACKGROUNDPrognosis of patients with relapsed or refractory acute lymphoblastic leukaemia is poor and new treatments are needed. We aimed to assess the feasibility, tolerability, dosimetry, and efficacy of yttrium-90-labelled anti-CD22 epratuzumab tetraxetan ((90)Y-DOTA-epratuzumab) radioimmunotherapy in refractory or relapsed CD22-positive B-cell acute lymphoblastic leukaemia in a standard 3 + 3 phase 1 study.METHODSAdults (≥18 years) with relapsed or refractory B-cell acute lymphoblastic leukaemia (with CD22 expression on at least 70% of blast cells) were enrolled at six centres in France. Patients received one cycle of (90)Y-DOTA-epratuzumab on days 1 and 8 (give or take 2 days) successively at one of four dose levels: 2·5 mCi/m(2) (92·5 MBq/m(2); level 1), 5·0 mCi/m(2) (185 MBq/m(2); level 2), 7·5 mCi/m(2) (277·5 MBq/m(2); level 3), and 10·0 mCi/m(2) (370 MBq/m(2); level 4). The primary objective was to identify the maximum tolerated dose of (90)Y-DOTA-epratuzumab. We assessed safety during infusions and regularly after radioimmunotherapy over a 6-month period. Analyses included only patients who received radioimmunotherapy. The trial is closed to inclusion and is registered at ClinicalTrials.gov, NCT01354457.FINDINGSBetween Aug 25, 2011, and June 11, 2014, 17 patients (median age 62 years; range 27-77) were treated (five at level 1, three at level 2, three at level 3, and six at level 4). Radioimmunotherapy infusion was overall well tolerated. One dose-limiting toxic effect (aplasia lasting 8 weeks) occurred at level 4, but the maximum tolerated dose was not reached. The most common grade 3-4 adverse events were pancytopenia (one patient at level 2, one at level 3, and six at level 4) and infections (three at level 1, one at level 2, and five at level 4).INTERPRETATION(90)Y-DOTA-epratuzumab radioimmunotherapy is well tolerated. We recommend the dose of 2 × 10·0 mCi/m(2) 1 week apart per cycle for phase 2 studies.FUNDINGImmunomedics and Direction de la Recherche Clinique of Nantes.

2014-11-01·Haematologica1区 · 医学

Anti-CD22 90Y-epratuzumab tetraxetan combined with anti-CD20 veltuzumab: a phase I study in patients with relapsed/refractory, aggressive non-Hodgkin lymphoma

1区 · 医学

Article

作者: Tomblyn, Michael B ; Sharkey, Robert M ; Wegener, William A ; Kio, Ebenezer A ; Goldenberg, David M ; Misleh, Jamal G ; Witzig, Thomas E

A lingering criticism of radioimmunotherapy in non-Hodgkin lymphoma is the use of cold anti-CD20 antibody along with the radiolabeled anti-CD20 antibody. We instead combined radioimmunotherapy with immunotherapy targeting different B-cell antigens. We evaluated the anti-CD22 (90)Y-epratuzumab tetraxetan with the anti-CD20 veltuzumab in patients with aggressive lymphoma in whom at least one prior standard treatment had failed, but who had not undergone stem cell transplantation. Eighteen patients (median age 73 years, median of 3 prior treatments) received 200 mg/m(2) veltuzumab once-weekly for 4 weeks, with (90)Y-epratuzumab tetraxetan at planned doses in weeks 3 and 4, and (111)In-epratuzumab tetraxetan in week 2 for imaging and dosimetry. Veltuzumab effectively lowered levels of B cells in the blood prior to the radioimmunotherapy doses. No significant immunogenicity or change in pharmacokinetics of either agent occurred in combination. (111)In imaging showed tumor targeting with acceptable radiation dosimetry to normal organs. For (90)Y-epratuzumab tetraxetan, transient myelosuppression was dose-limiting with 6 mCi/m(2) (222 MBq/m(2)) × 2 being the maximal tolerated dose. Of 17 assessable patients, nine (53%) had objective responses according to the 2007 revised treatment response criteria, including three (18%) complete responses (2 relapsing after 11 and 13 months, 1 continuing to be clinically disease-free at 19 months), and six (35%) partial responses (1 relapsing after 14 months, 5 at 3 - 7 months). Responses occurred in patients with different lymphoma histologies, treated at different (90)Y dose levels, and with a predicted risk of poor outcome, most importantly including five of the six patients treated with the maximal tolerated dose (2 of whom achieved durable complete responses). In conclusion, the combination of (90)Y-epratuzumab tetraxetan and veltuzumab was well-tolerated with encouraging therapeutic activity in this difficult-to-treat population.

100 项与 Epratuzumab Y-90 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
前体B细胞急性淋巴细胞白血病	申请上市	法国	Nantes University Hospital	2016-07-26
淋巴细胞白血病	申请上市	-	Nantes University Hospital	2015-10-16
B细胞淋巴瘤	临床3期	法国	Gilead Sciences, Inc.	2002-08-01
CD22阳性B细胞急性淋巴细胞白血病	临床2期	法国	Nantes University Hospital	2016-07-26
淋巴细胞白血病	临床2期	-	Gilead Sciences, Inc.	2015-10-16
难治性 B 细胞急性淋巴细胞白血病	临床2期	法国	Nantes University Hospital	2010-11-01
滤泡性淋巴瘤	临床2期	美国	Gilead Sciences, Inc.	2010-10-01
侵袭性 B 细胞非霍奇金淋巴瘤	临床2期	美国	Gilead Sciences, Inc.	2010-05-01
弥漫性大B细胞淋巴瘤	临床2期	美国	Gilead Sciences, Inc.	2010-05-01
B细胞淋巴瘤	临床2期	德国	Gilead Sciences, Inc.	2002-08-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00906841 (Pubmed \| Lancet Haematol) 人工标引	临床2期	弥漫性大B细胞淋巴瘤	71	R-CHOP+90 Y-epratuzumab tetraxetan	(積範積艱廠積積窪築襯) = 製廠遞膚網繭簾繭鏇壓憲鏇積醖構膚蓋齋獵廠 (餘鑰觸壓簾壓鹹廠顧鹹, 63 ~ 84)	积极	2017-01-01
NCT01354457 (Pubmed \| Lancet Haematol) 人工标引	临床1期	CD22阳性B细胞急性淋巴细胞白血病 CD22 Positive	17	Y-DOTA-epratuzumab	(構鹹窪獵窪齋鏇壓顧糧) = 鬱糧製齋簾艱鹹憲糧糧繭醖醖製蓋構鬱鹽艱夢 (簾廠憲淵網繭餘齋鏇範 ) 更多	积极	2015-03-01