Phase I/II Dose-escalation Study of the Investigational Trifunctional Bispecific Anti-CD20 x Anti-CD3 Antibody FBTA05 in Combination With Donor Lymphocyte Infusion (DLI) in Patients With CD20 Positive Chronic Lymphocytic Leukemia (CLL), Low and High Grade Non-Hodgkin´s Lymphoma (NHL) After Allogeneic Stem Cell Transplantation

This study is an investigator driven, open-label, non-randomized, uncontrolled, dose escalating Phase I/II study evaluating the safety and preliminary efficacy of the trifunctional bispecific antibody FBTA05 in combination with donor lymphocyte infusions (DLI) for treatment of relapsed or refractory disease in CD20 positive either low- or high-grade non-Hodgkin´s lymphoma after allogeneic transplantation

开始日期2010-08-01

申办/合作机构

Technische Universität München

100 项与 FBTA-05 相关的临床结果

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100 项与 FBTA-05 相关的转化医学

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100 项与 FBTA-05 相关的专利（医药）

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项与 FBTA-05 相关的文献（医药）

2020-11-25·Journal of Drug Targeting3区 · 医学

Immunotargeting and therapy of cancer by advanced multivalence antibody scaffolds

3区 · 医学

Review

作者: Omidi, Yadollah ; Barar, Jaleh ; Saei, Amir Ata ; Kafil, Vala ; Tohidkia, Mohammad Reza

Monoclonal antibodies (mAbs) are a swiftly growing class of targeted therapeutics for malignancies. After their first advent, the antibody (Ab) engineering trail has shown an evolutionary trajectory - from the rodent-derived Abs to the chimeric, humanised and fully human Abs with higher efficacy and lower/no immunotoxicity. Despite possessing great clinical potentials, several reports have highlighted that monospecific mAbs, even with high-affinity, often fail to induce sufficient immunologic responses. The full activation of the immune system demands cooperative interactions of immunotherapies with target antigen (Ag) towards functional avidity. Although the monospecific mAbs show affinity to a target Ag, they often fail to render sufficient avidity necessary for the activation of intracellular signalling mechanisms and the provocation of the immune system. Thus, various Ab/non-Ab scaffolds with much greater therapeutic impacts have been engineered based on the adjustment of their affinity and avidity balance. Novel multivalent Ab scaffolds (e.g. MDX-447, MT110, CD20Bi, TF2 and FBTA05) and mimetic Abs (e.g. adnectin, DARPins and ecallantide) offer improved pharmacokinetic and pharmacodynamic properties. Here, we discuss the avidity and multivalency and provide comprehensive insights into advanced Ab scaffolds used for immunotargeting and therapy of cancer.

2017-08-03·Leukemia & Lymphoma

Immunotherapy with the trifunctional anti-CD20 × anti-CD3 antibody FBTA05 in a patient with relapsed t(8;14)-positive post-transplant lymphoproliferative disease

Letter

作者: Ruf, Peter ; Eggert, Angelika ; Buhmann, Raynold ; Lindhofer, Horst ; Kieslich, Anna ; Hundsdoerfer, Patrick

B-cell lymphomas are common malignancies during infancy and childhood with excellent long-term cure rates. However, relapse or refractory disease associated with very poor prognosis (especially for...

2017-05-01·Clinical and Translational Science3区 · 医学

Clinical Pharmacology and Translational Aspects of Bispecific Antibodies

3区 · 医学

ReviewOA

作者: Kasichayanula, S ; Stienen, S ; Gibbs, J ; Heath, T ; Trivedi, A ; Li, H ; Zhu, M ; Loberg, R ; Yuraszeck, T

Development of bispecific antibodies (BsAbs) as therapeutic agents has recently attracted significant attention, and investments in this modality have been steadily increasing. This review discusses challenges, and suggestions to overcome them, associated with the development of BsAbs, specifically those pertaining to clinical pharmacology, pharmacometrics, and bioanalysis. These challenges and possible solutions are discussed by presenting several case studies of BsAbs that have gained regulatory approval or that are currently in clinical development. BsAbs, also termed “dual‐targeting” or “dual‐specificity” antibodies, have the ability to bind two different targets on the same or different cell(s); the targets may be cell‐surface receptors or soluble ligands, as shown in Figure 1.1. These dual‐nature antibodies have key advantages that can potentially enhance therapeutic efficacy compared with monotherapy or traditional combination therapies by: i) simultaneously blocking two different targets or mediators that have a primary role in the disease pathogenesis; ii) inducing cell signaling pathways (e.g., proliferation or inflammation); iii) retargeting to mediate antibody‐dependent cell‐mediated cytotoxicity (ADCC); iv) avoiding the development of resistance and increasing antiproliferative effects, specifically in oncology; and v) temporarily engaging a patient's own cytotoxic T cells to target cancer cells, thus activating cytotoxic T cells to cause tumor lysis (e.g., bispecific T‐cell engagers (BiTE)). Open in a separate window Figure 1 Various designs for BsAb molecules (a) Dimers inhibition: BsAbs can bind to two receptors/targets (HER2/HER3, HER2/HER4) on the same cell (e.g., MM‐111); (b) Dual inhibition: BsAbs can inhibit two different cytokines simultaneously, for example, COVA322 that inhibits TNF‐α and IL17A; (c) Triomabs: The antigen binding site binds to target cell receptors (EpCAM, HER2, or CD20) and the T‐cell receptors (CD3). The heavy chain site binds to NK cells or dendritic cells or macrophages/phagosome (e.g., catumaxomab, ertumaxomab, FBTA05); (d) Two‐ligand inactivation: two arms bind to different ligands on different cells belonging to the same population, such as DLL4 x VEGF, TNF‐α x IL17A, IL4 x IL13 (e.g., OMP‐305B83, COVA322, SAR156597); (e) Transmembrane/transcytosis: The BsAbs are designed specifically to cross the barriers/membrane via receptor transport (transferrin receptor) and bind to enzymes/receptors (BACE1) on the other side; (f) BiTE antibody construct: These are designed to bridge T cells and target cells by binding to CD3/CD28 or CD19/CD20/CD22/CEA/EpCAM, respectively (e.g., blinatumomab, MEDI‐565, MT110). The examples mentioned above can be found in Table 2 for further information. BACE1, β‐secretase 1; BiTE, bispecific T‐cell engagers; BsAbs, bispecific antibodies; DDL4, delta‐like ligand 4; EpCAM, epithelial cell adhesion molecule; HER, human epidermal growth factor receptor; IL, interleukin; NK, Natural Killer; TNF‐α, tumor necrosis factor‐alpha; VEGF, vascular endothelial growth factor.

100 项与 FBTA-05 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
CD20阳性B细胞慢性淋巴细胞白血病	临床2期	德国	Technische Universität München	2010-08-01
B细胞淋巴瘤	临床2期	-	TRION Research GmbH	-
B细胞淋巴瘤	临床2期	德国	Trion Pharma GmbH	-
慢性淋巴细胞白血病	临床2期	德国	Trion Pharma GmbH	-
淋巴细胞白血病	临床2期	-	TRION Research GmbH	-