DI-Leu16-IL2(DI-Leu16-IL2) - 药物靶点：CD20 x IL-2R_在研适应症：非霍奇金淋巴瘤，淋巴瘤_专利_临床

概要

基本信息

药物类型

抗体融合蛋白

别名

Anti-CD20 monoclonal antibody-interleukin-2 fusion protein、DI-Leu16-IL2 immunocytokine、de-immunized anti-CD20-IL-2 immunocytokine DI-Leu16-IL-2

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靶点

CD20 x IL-2R

作用机制

CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、IL-2R激动剂(白细胞介素-2受体复合体激动剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

City of Hope National Medical CenterEMD Lexigen Research Center Corp.Merck Serono SA

+ [1]

非在研机构

Alopexx Oncology, LLC

最高研发阶段临床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/序列

Sequence Code 16279555VH

Sequence Code 14671992VL

关联

3

项与 DI-Leu16-IL2 相关的临床试验

NCT02151903

/ Terminated临床1/2期

An Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Patients With B-cell Non-Hodgkin Lymphoma (NHL)

This is an open-label extension study enrolling participants experiencing clinical benefit following 6 cycles of DI-Leu16-IL2 while enrolled in the Alopexx Oncology Dose-Escalation AO-101 study (NCT01874288). Participants will be permitted to continue to receive DI-Leu16-IL2 at the same dose, schedule, and route of administration they received during Study AO-101 (Main Study). Prior pre-treatment (for example, Rituximab) will continue as before.

开始日期2014-11-04

申办/合作机构

Alopexx Oncology, LLC

NCT01874288

/ Terminated临床1/2期

A Phase I/II Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered Subcutaneously in Patients With B-cell Non-Hodgkin Lymphoma (NHL)

This dose-escalation study is designed for determining the safety, tolerability, pharmacokinetics (PK), biological, and clinical activity of DI-Leu16-IL2 administered to participants with cluster of differentiation 20 (CD20) positive NHL that have failed standard rituximab-containing therapy.

开始日期2013-11-25

申办/合作机构

Alopexx Oncology, LLC

NCT00720135

/ Completed临床1期IIT

A Phase I Study of De-Immunized DI-Leu16-IL2 Immunocytokine in Patients With B-Cell Non-Hodgkin Lymphoma

RATIONALE: Biological therapies, such as fusion protein cytokine therapy, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fusion protein cytokine therapy together with rituximab may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of fusion protein cytokine therapy when given after rituximab in treating patients with B-cell non-Hodgkin lymphoma.

开始日期2008-01-01

申办/合作机构

City of Hope National Medical Center

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100 项与 DI-Leu16-IL2 相关的临床结果

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100 项与 DI-Leu16-IL2 相关的转化医学

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100 项与 DI-Leu16-IL2 相关的专利（医药）

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4

项与 DI-Leu16-IL2 相关的文献（医药）

2015-07-01·Clinical Lymphoma Myeloma and Leukemia4区 · 医学

Three Newly Approved Drugs for Chronic Lymphocytic Leukemia: Incorporating Ibrutinib, Idelalisib, and Obinutuzumab into Clinical Practice

4区 · 医学

Review

作者: Burger, Jan A ; Wierda, William G ; Sanford, David S ; O'Brien, Susan M ; Keating, Michael J

Three agents have received Food and Drug Administration (FDA) approval for treatment of chronic lymphocytic leukemia (CLL) within the past year. Ibrutinib and idelalisib block B-cell receptor signaling through inhibition of Bruton tyrosine kinase and phosphatidylinositol 3-kinase δ molecules respectively, interfering with several pathways required for leukemia cell survival. Idelalisib has shown efficacy in the relapsed setting and is currently approved by the FDA for use in combination with rituximab. Ibrutinib has been studied in patients with relapsed CLL and as frontline therapy. In the relapsed setting, these agents produce durable remissions, and might be preferable to re-treatment with chemoimmunotherapy for many patients. Ibrutinib is also effective treatment for patients with deletion 17p and is approved by the FDA as frontline therapy in this patient group, although it does not appear to completely abrogate this adverse prognostic factor. These agents have a unique side effect profile and longer follow-up is required to further understand tolerability and rare adverse effects. Obinutuzumab is a type-2 monoclonal anti-CD20 antibody which results in direct and antibody-dependent cell-mediated cytotoxicity of leukemia cells. It is approved by the FDA for use in combination with chlorambucil, and has shown efficacy in the frontline setting in patients unfit for more intensive chemoimmunotherapy. It produces increased response rates and minimal residual disease negativity compared with chlorambucil/rituximab and is associated with an advantage in progression-free survival but not yet overall survival. These agents underscore our advancement in the understanding of the biology of CLL and will improve outcomes for many patients with CLL.

2010-02-01·Current opinion in molecular therapeutics

TRU-015, a fusion protein derived from an anti-CD20 antibody, for the treatment of rheumatoid arthritis.

Review

作者: Rubbert-Roth, Andrea

TRU-015, being developed by Trubion Pharmaceuticals Inc and Pfizer Inc, is an intravenously administered anti-CD20 IgG fusion protein for the treatment of rheumatoid arthritis. TRU-015 depletes B-cells from the peripheral blood in vitro, and can mediate complement-and antibody-dependent cellular cytotoxicity. TRU-015 was well tolerated in patients with rheumatoid arthritis in phase I and II clinical trials, and demonstrated an efficacy profile similar to other biological agents approved for rheumatoid arthritis. At the time of publication, phase II trials were ongoing in patients with rheumatoid arthritis. TRU-015 could represent a novel therapy for the treatment of rheumatoid arthritis, although the efficacy, safety profile and advantages of this compound compared with existing therapeutic options would need to be established in phase III trials. In addition, this agent also may be useful to the treatment of B-cell neoplasms and autoimmune diseases.

2007-03-15·Cancer Research1区 · 医学

Combining Adoptive Cellular and Immunocytokine Therapies to Improve Treatment of B-Lineage Malignancy

1区 · 医学

Article

作者: Forman, Stephen J. ; Serrano, Lisa Marie ; Singh, Harjeet ; Colcher, David ; Gillies, Stephen D. ; McNamara, George ; Olivares, Simon ; Jensen, Michael C. ; Raubitschek, Andrew ; Pfeiffer, Timothy ; Al-Kadhimi, Zaid ; Cooper, Laurence J.N. ; Smith, David D.

AbstractCurrently, the lineage-specific cell-surface molecules CD19 and CD20 present on many B-cell malignancies are targets for both antibody- and cell-based therapies. Coupling these two treatment modalities is predicted to improve the antitumor effect, particularly for tumors resistant to single-agent biotherapies. This can be shown using an immunocytokine, composed of a CD20-specific monoclonal antibody fused to biologically active interleukin 2 (IL-2), combined with ex vivo expanded human umbilical cord blood–derived CD8+ T cells, that have been genetically modified to be CD19 specific, for adoptive transfer after allogeneic hematopoietic stem-cell transplantation. We show that a benefit of targeted delivery of recombinant IL-2 by the immunocytokine to the CD19+CD20+ tumor microenvironment is improved in vivo persistence of the CD19-specific T cells, and this results in an augmented cell-mediated antitumor effect. Phase I trials are under way using anti-CD20-IL-2 immunocytokine and CD19-specific T cells as monotherapies, and our results warrant clinical trials using combination of these two immunotherapies. [Cancer Res 2007;67(6):2872–80]

100 项与 DI-Leu16-IL2 相关的药物交易

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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
B细胞淋巴瘤	临床2期	美国	Alopexx Oncology, LLC	2013-11-25
非霍奇金淋巴瘤	临床2期	-	Provenance Biopharmaceuticals Corp.	-
非霍奇金淋巴瘤	临床2期	-	Merck Serono SA	-
淋巴瘤	临床前	美国	EMD Lexigen Research Center Corp.	2004-11-16
淋巴瘤	临床前	美国	City of Hope National Medical Center	2004-11-16

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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


NCT02151903 (CTgov)	临床1/2期	B细胞淋巴瘤	5	DI-Leu16-IL2 (DI-Leu16-IL2 1.0 mg/m^2)	(觸鬱鏇獵積廠積構憲鬱) = 齋築蓋醖膚窪鹽壓鹽鏇簾積齋選襯蓋鬱艱襯鏇 (窪壓憲蓋築齋鹽選顧齋, 範鹽簾積醖夢壓憲鹽簾 ~ 憲夢繭壓壓繭選淵餘鹽) 更多	-	2020-11-27
				DI-Leu16-IL2 (DI-Leu16-IL2 2.0 mg/m^2)	(觸鬱鏇獵積廠積構憲鬱) = 廠蓋廠獵獵製夢壓淵鏇簾積齋選襯蓋鬱艱襯鏇 (窪壓憲蓋築齋鹽選顧齋, 襯鬱淵顧構選艱網襯淵 ~ 繭網遞獵憲壓壓襯觸鏇) 更多
NCT01874288 (DI-Leu16-IL2, CTgov)	临床1/2期	B细胞淋巴瘤	24	DI-Leu16-IL2 (DI-Leu16-IL2 0.5 mg/m^2)	淵淵夢積範襯選齋膚構(齋憲夢壓齋製願襯鬱襯) = 鏇觸壓衊醖網觸鬱襯衊獵艱壓觸顧鹽襯鬱醖遞 (繭艱觸齋製網鬱鑰鹽築, 選壓餘網蓋艱網繭繭鹽 ~ 鑰廠壓鏇鑰構窪構餘齋) 更多	-	2020-11-24
				DI-Leu16-IL2 (DI-Leu16-IL2 1.0 mg/m^2)	淵淵夢積範襯選齋膚構(齋憲夢壓齋製願襯鬱襯) = 顧構鑰齋鏇艱醖糧觸糧獵艱壓觸顧鹽襯鬱醖遞 (繭艱觸齋製網鬱鑰鹽築, 齋廠餘襯鑰餘鏇積鹹窪 ~ 齋窪繭憲齋衊廠淵鏇夢) 更多
NCT01874288 (ASCO2016)	临床1/2期	复发性B细胞淋巴瘤	18	DI-Leu16-IL2	鹹鬱顧範鹽範網鏇鏇襯(簾窪簾願襯構衊築窪醖) = DLT occurred in 2 pts at 6 mg/m2 with delayed (8-10 days) grade 3 cytokine release syndrome, suggesting effector cell expansion as the cause. 積廠窪鏇鹹築衊網蓋襯 (繭遞築夢憲獵蓋壓鬱襯 ) 更多	积极	2016-05-20