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    DRUG:

    Columvi (glofitamab-gxbm)

    i
    Other names: RG6026, RO7082859, CD20 TCB, RG 6026, RO-7082859, RO 7082859, anti-CD20 CD3 TCB, RG-6026
    Company:
    Biogen, Roche
    Drug class:
    CD20 inhibitor, CD3 agonist
    Related drugs:
    4d
    Immune Effector Cell-Associated HLH-Like Syndrome (IEC-HS) in CAR-T and TCE-Treated Myeloma and B-Cell Malignancies: Insights from a Pharmacovigilance Study. (PubMed, Transplant Cell Ther)
    IEC-HS is a rare but potentially fatal complication. Our disproportionality analysis identifies significant reporting signals for tisa-cel and cilta-cel. The high absolute number of cases observed for products like axi-cel appears to reflect high utilization rather than a disproportionate risk, underscoring the necessity of using statistical signal detection methods when interpreting spontaneous reports.
    Journal • Adverse events
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    ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
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    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • Epkinly (epcoritamab-bysp) • Elrexfio (elranatamab-bcmm) • Tecartus (brexucabtagene autoleucel) • Abecma (idecabtagene vicleucel) • Carvykti (ciltacabtagene autoleucel) • Lunsumio (mosunetuzumab-axgb) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv) • Columvi (glofitamab-gxbm)
    7d
    Bispecific antibody combination regimens for B-cell non-Hodgkin's lymphomas. (PubMed, Expert Opin Biol Ther)
    BsAbs such as epcoritamab, glofitamab, and mosunetuzumab have demonstrated substantial efficacy across both aggressive and indolent B-cell non-Hodgkin lymphomas (B-NHL), with largely manageable safety profiles...Approaches incorporating BsAbs into cytotoxic backbones and antibody-drug conjugates, as well as chemotherapy-free regimens such as BsAbs combined with lenalidomide, are discussed...BsAbs represent a major advance in B-NHL, offering high rates of deep remission with predictable safety and outpatient feasibility. As trial data continues to mature, BsAb-based regimens are poised to become foundational across multiple lines of therapy, reshaping expectations for patients with both aggressive and indolent lymphomas.
    Review • Journal
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    CD20 (Membrane Spanning 4-Domains A1)
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    lenalidomide • Epkinly (epcoritamab-bysp) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm)
    16d
    Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy (clinicaltrials.gov)
    P2, N=20, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Oct 2025 --> Aug 2026
    Enrollment open • Trial initiation date
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    Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm)
    16d
    Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WINDOW-4 Study (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
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    Rituxan (rituximab) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • Columvi (glofitamab-gxbm)
    17d
    GO43693: A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma (clinicaltrials.gov)
    P1, N=43, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Oct 2025 | Trial primary completion date: Dec 2026 --> Oct 2025
    Trial completion • Trial completion date • Trial primary completion date
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    TNFA (Tumor Necrosis Factor-Alpha)
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    carboplatin • Rituxan (rituximab) • Gazyva (obinutuzumab) • ifosfamide • etoposide IV • Actemra IV (tocilizumab) • Columvi (glofitamab-gxbm)
    28d
    The Efficacy and Safety of Glofitamab in Combination With PD-1 Antibody and Lenalidomide in Patients With Relapsed/Refractory Large B-cell Lymphoma (LBCL) With TP53 Aberrations: A Prospective, Multicenter, Phase II Clinical Study (clinicaltrials.gov)
    P2, N=24, Recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial • IO biomarker
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    lenalidomide • Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm)
    1m
    GO43075: A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
    P2, N=46, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Oct 2024 --> Sep 2026
    Trial primary completion date • Circulating tumor DNA
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    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • BCL6 (B-cell CLL/lymphoma 6)
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    CD20 positive
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    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Actemra IV (tocilizumab) • Columvi (glofitamab-gxbm)
    2ms
    CO43805: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=121, Recruiting, Hoffmann-La Roche | Trial completion date: Mar 2029 --> Sep 2029 | Trial primary completion date: Mar 2027 --> Sep 2029
    Trial completion date • Trial primary completion date
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    CD20 (Membrane Spanning 4-Domains A1)
    |
    Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb) • iberdomide (CC-220) • Columvi (glofitamab-gxbm) • golcadomide (CC-99282)
    2ms
    GOlDiLOX: NHL37 - A phase I/II study to assess safety of combining Glofitamab and Pirtobrutinib (LOXo-305) for treatment in patients with Mantle Cell Lymphoma (MCL) and prior therapy with a BTK inhibitor. (ACTRN12622001275752)
    P1/2, N=48, Recruiting, Australasian Leukaemia and Lymphoma Group (ALLG) | Not yet recruiting --> Recruiting
    Enrollment open
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    Jaypirca (pirtobrutinib) • Columvi (glofitamab-gxbm)
    2ms
    EZH2 suppresses the chemosensitivity of diffuse large B cell lymphoma via regulating TP53INP1. (PubMed, Clin Exp Med)
    EZH2 deficiency effectively enhances the chemosensitivity of DLBCL cells to Glofitamab, manifested by promoting Glofitamab-mediated inhibition in the proliferation, migration, and invasion of DLBCL cells...In summary, EZH2 inhibits the progression of DLBCL via driving H3K27me3 methylation of TP53INP1. Targeting EZH2 may be a promising strategy for DLBCL.
    Journal
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    TP53INP1 (Tumor Protein P53 Inducible Nuclear Protein 1)
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    Columvi (glofitamab-gxbm)
    2ms
    Glofitamab combined with DHAP/X as salvage therapy for relapsed/refractory autologous transplant-eligible HIV-associated diffuse large B-cell lymphoma (ChiCTR2500107379)
    P=N/A, N=20, Not yet recruiting, Chongqing University Cancer Hospital,China; Chongqing University Cancer Hospital
    New trial
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    CD4 (CD4 Molecule)
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    cisplatin • cytarabine • oxaliplatin • dexamethasone • Columvi (glofitamab-gxbm)
    2ms
    GlofitReal: An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
    P=N/A, N=300, Recruiting, Hoffmann-La Roche | Trial completion date: Jul 2030 --> Sep 2029
    Trial completion date
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    Columvi (glofitamab-gxbm)