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    Obinutuzumab

    Other names: RG7159; RO5072759

    Modality: Humanized, Type II anti-CD20 monoclonal antibody

    Disease State: Pediatric Nephrotic Syndrome (PNS), Systemic Lupus Erythematosus (SLE), Membranous Nephropathy

    Summary

    Gazyva (obinutuzumab, RG7159, GA101) is a Type II, humanized anti-cluster of differentiation (CD) 20 monoclonal antibody (mAb) with a modified Fc region. It has a distinct mode of action compared with Type I anti-CD20 mAbs, such as rituximab and was specifically designed to selectively target the CD20 protein on B cells and to bind with high affinity to the cell surface in a type II configuration.1-3

    Clinical Trials

    Obinutuzumab
    NCT ID Study Phase Enrollment Status Study Title
    NCT05039619 Phase II Recruiting A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants View details
    NCT05627557 Phase III Active, not recruiting A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome View details
    NCT04963296 Phase III Active, not recruiting A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus View details
    NCT04629248 Phase III Active, not recruiting A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy View details
    NCT04221477 Phase III Active, not recruiting A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis View details

    Proposed Mechanism of Action

    Obinutuzumab is a humanized, Type II monoclonal antibody designed to target the CD20 antigen expressed on the surface of pre-B and mature B lymphocytes.1-3 Upon binding to CD20, obinutuzumab mediates B-cell lysis through:

    1. engagement of immune effector cells,
    2. by directly activating intracellular death signaling pathways (direct cell death), and/or 
    3. activation of the complement cascade.

    The immune effector cell mechanisms include antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis.1-3

    As an antibody with reduced fucose content, obinutuzumab induces greater ADCC activity than rituximab in vitro using human cancer cell lines.1-4 Obinutuzumab also demonstrated an increased ability to induce direct cell death when compared to rituximab, with less reliance on complement-dependent cytotoxicity.1-5 Obinutuzumab binds to FcRIII using purified proteins with a higher affinity than rituximab.1-4 Obinutuzumab and rituximab bind with similar affinity to overlapping epitopes on CD20.1,2,4

    Obinutuzumab has been shown to deplete B cells in peripheral blood, lymphoid tissue, and renal tissue.5,6

    1. Mössner E, Brünker P, Moser S, et al. Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell-mediated B-cell cytotoxicity. Blood. 2010;115(22):4393​-4402. doi:10.1182/​blood-2009-06-225979 
    2. Herter S, Herting F, Mundigl O, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013;12(10):2031-2042. doi:10.1158/​1535-7163.MCT-12-1182
    3. Tobinai K, Klein C, Oya N, et al. A review of obinutuzumab (GA101), a novel type II anti-CD20 monoclonal antibody, for the treatment of patients with B-cell malignancies. Adv Ther. 2017;34(2):324-356. doi:10.1007/​s12325-016-0451-1
    4. Klein C, Lammens A, Schäfer W, et al. Epitope interactions of monoclonal antibodies targeting CD20 and their relationship to functional properties. mAbs. 2013;5(1):22-33. doi:10.4161/​mabs.22771
    5. Looney CM, Schroeder A, Taveres E, et al. Obinutuzumab effectively depletes key B-cell subsets in blood and tissue in end-stage renal disease patients. Transplant Direct. 2023;9(2):e1436. doi:10.1097/​TXD.0000000000001436
    6. Rovin BH, Martins E, Austin CD, et al. Obinutuzumab leads to deep B-cell depletion in the kidney parenchyma of patients with lupus nephritis: an exploratory analysis of the REGENCY trial. Poster presented at: American College of Rheumatology Convergence; October 24-29, 2025; Chicago, IL. Presentation LB13.

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    TOP

    • ADCC
      Antibody-dependent cellular cytotoxicity

    • CD
      Cluster of differentiation

    • mAb
      Monoclonal antibody

    • PNS
      Pediatric nephrotic syndrome

    • SLE
      Systemic lupus erythematosus

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