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Study Type : Interventional (Clinical Trial) Estimated Enrollment : 24 participants Intervention Model: Sequential Assignment Intervention Model Description: 3+3 sequential cohort design Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase I Open-label, Multiple Dose Study of CHO-H01 Administered Intravenously as a Single Agent to Subjects With Refractory or Relapsed Follicular Lymphoma
Anticipated Study Start Date : March 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019
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°Ñ¦Ò½×¤å A common glycan structure on immunoglobulin G for enhancement of effector functions http://www.pnas.org/content/112/34/10611.full
Binding Affinity and the B-Cell Depletion Activity of Various Afucosylated Rituximab Glycoforms
The ADCC of 2,6-NSCT-Rituximab Toward Resistant Cell Lines ¹³³\¦hÃÄ«~¡A¤@¨Ç±wªÌ¹ï§Q§´©õ³æ§Ü§Ü©Ê¥Ñ©ó°ª¾¯¶q©Mªø´Á¨Ï¥Î¡]37¡A38¡^¡C¬°¤F¤F¸Ñ2,6-NSCT-§Q§´©õ³æ§Ü¬O§_¹ï@ÃIJÓM¦³®Ä¡A§ÚÌ»s³Æ¤FRamos©MRaji Rituximab§Ü©Ê²ÓM¨t¡A¥Hµû¦ô¨ä¦b¤£¦P¿@«×ªº2,6-NSCT-§Q§´©õ³æ§Ü¤UªºPBMC¤¶¾ÉªºADCC¡]¹Ï1¡^¡C 2 C - E¡^¡C¦b»P§Q§´©õ³æ§Ü¦@°ö¾i«á¡ARamos©MRaji B²ÓM¦b²ÓMªí±¤Wºt¤Æ¦¨¬°¨ã¦³§CCD20ªí¹Fªº@¨ü§Q§´©õ³æ§Ü¡]¹Ï2C¡^¡Cµ²ªG¡A«D×¹¢ªº§Q§´©õ³æ§Ü¤j¤j³à¥¢¤F§Ü§Ü©Êµß®èªº¬¡©Ê¡]¹Ï2D©ME¡^¡A¦ý¬O2,6-NSCT§Q§´©õ³æ§ÜÅã¥Ü¥X¹ï§Ü©Ê©M§Ü©Ê²ÓMªºADCC¬¡©ÊÅãµÛ¡C(google½Ķ) http://www.pnas.org/content/112/34/10611/F2.large.jpg
Fc£^RIIIa Binding Affinity of Various Afucosylated Herceptin Glycoforms
The ADCC Effect of the 2,6-NSCT Glycan Modification on Antiviral Antibodies
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MOR208¬O¤@´Ú³B¦b¬ã¨s¶¥¬qªºFc¬q×¹¢³æ§J¶©§ÜÅéÃĪ«¡A¹v¦VCD19¡A¥Ø«e¦b¶i¦æªºÁ{§É¬ã¨s¬O¥Î©ó¦å²G¸~½FªºªvÀø¤è¦V¡C
FDA¬ð¯}©ÊÀøªkªº»{©w¬O°ò©ó¥Ø«e¶i¦æ¤¤ªºÁ{§É2´Á¬ã¨sL-MIND¡]µn°O¸¹¬°NCT02399085¡^ªºªì¨B¬ã¨s¼Æ¾Ú¡A¸Ó¬ã¨s¹ïMOR208Áp¦X¨Ó¨º«×ÓiªvÀø¤£¾A©y±µ¨ü°ª¾¯¶q¤ÆÀø¤Î¦ÛÅé·F²ÓM²¾´Óªº½Æµo/Ãøªv©ÊDLBCL±wªÌ¶i¦æ¤F¦w¥þ©Ê©M¦³®Ä©Êµû¦ô¡Cªì¨B¬ã¨s¼Æ¾Ú¨Ó¦Û©ó34¨Ò¦X®æ±wªÌ¡A¼Æ¾Ú¤w¦b2017¦~ªºASCO¤W¶i¦æ¤F¤½§G¡Aµ²ªGÅã¥Ü¡A«ÈÆ[À³µª²v¡]ORR¡^¹F¨ì56%¡A§¹¥þ½w¸Ñ²v¬°32%¡C |
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¤º®eºK¦Û Evolution of anti-CD20 monoclonal antibody therapeutics in oncology https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2828574/
Second generation antibodies can be tailored to be humanized or fully human with unmodified Fc domain, with the aim of reducing immunogenicity. Likewise, third generation antibodies can be modified to include engineered Fc domains with the aim of improving the therapeutic activity in all patients, particularly in genetically defined subpopulations that express a low affinity version of the Fc receptor on their immune effector cells.
Second generation antibodies include ofatumumab, ocrelizumab and veltuzumab.
Third generation anti-CD20 mAbs in early phases of clinical development include AME133v, Pro13192 (v114), GA101 and R603/EMAB-6.
AME-133v, an Fc protein engineered antibody, is currently being evaluated in a Phase 1/2 dose escalation study using weekly intravenous doses for four consecutive weeks in patients with relapsed/refractory follicular B cell NHL. In vitro models have shown that the Fc domain of AME-133v binds to the low-affinity variant of Fc gamma RIIIa (FF or FV) with a higher affinity (mean EC50 <10 ng/ml) thereby improving killing of B cells ∼10 fold over rituximab
Pro131921 (v114), is another Fc protein engineered antibody and displays 30-fold greater binding to the low-affinity variant of Fc gamma RIIIa (FF or FV) than rituximab.65 In vitro, this binding affinity exhibits improved ADCC activity up to 10 fold more than rituximab.
GA101 is a third-generation anti-CD20 mAb with a glyco-engineered Fc portion which exhibits improved binding affinity to FcgammaRIII by 50-fold, that results in a 10- to 100-fold increase in ADCC against CD20 positive NHL cell lines.
Obinutuzumab (GA101) https://en.wikipedia.org/wiki/Obinutuzumab
Obinutuzumab is used in combination with chlorambucil as a first-line treatment for chronic lymphocytic leukemia.[2] Its progression-free survival is better than rituximab in the same combination (26.7 months vs. 15.2 months) but its overall survival rate is not better (8% vs. 12%). Obinutuzumab has two black box warnings: hepatitis B reactivation and progressive multifocal leukoencephalopathy.[2] In the pivotal clinical trial of obinutuzumab in combination with chlorambucil, clinical trial subjects experienced infusion reactions (69%; 21% grade 3/4), neutropenia (40%; 34% grade 3/4), thrombocytopenia (15%; 11% grade 3/4), anemia (12%), and pyrexia and cough (10% each). More than 20% of subjects had abnormal lab tests including low calcium and sodium, high potassium, increases in serum creatinine and liver function tests, and low albumin levels.[2] There is a risk of thrombocytopenia and hemorrhage with obinutuzumab, consideration should be given to withholding medications that may increase the risk of bleeding
LFB-R603/EMAB-6 is a chimeric third generation IgG1 and is produced in rat cell line YB2/0 using EMABLING technology thus resulting in naturally low fucose content in its Fc region.Compared to rituximab, LFB-R603/EMAB-6 has similar CDC and PCD activities whereas Fc£^RIIIA binding and Fc£^RIIIA-dependent effector functions are higher and results in producing an ADCC plateau around 35% at 50 ng/ml, while rituximab induced less than 5% ADCC at the same concentration.76 Furthermore, LFB-R603/EMAB-6 induces higher ADCC activity against CLL cells than rituximab even when target cells express fewer CD20 molecules.
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