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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:
    2d
    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
    |
    Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm)
    2d
    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
    |
    Rituxan (rituximab) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • Columvi (glofitamab-gxbm)
    3d
    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
    |
    TNFA (Tumor Necrosis Factor-Alpha)
    |
    carboplatin • Rituxan (rituximab) • Gazyva (obinutuzumab) • ifosfamide • etoposide IV • Actemra IV (tocilizumab) • Columvi (glofitamab-gxbm)
    14d
    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
    |
    lenalidomide • Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm)
    16d
    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
    |
    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)
    |
    CD20 positive
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Actemra IV (tocilizumab) • Columvi (glofitamab-gxbm)
    1m
    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
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb) • iberdomide (CC-220) • Columvi (glofitamab-gxbm) • golcadomide (CC-99282)
    1m
    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
    |
    Jaypirca (pirtobrutinib) • Columvi (glofitamab-gxbm)
    1m
    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
    |
    TP53INP1 (Tumor Protein P53 Inducible Nuclear Protein 1)
    |
    Columvi (glofitamab-gxbm)
    1m
    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
    |
    CD4 (CD4 Molecule)
    |
    cisplatin • cytarabine • oxaliplatin • Columvi (glofitamab-gxbm)
    1m
    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
    |
    Columvi (glofitamab-gxbm)
    1m
    Current progress and latest therapeutic options in immuno-oncology (PubMed, Dtsch Med Wochenschr)
    For solid cancers, these comprise the antibody-drug-conjugate Mirvetuximab Soravtansine for platinum-resistant ovarian cancer, the monoclonal antibody Zolbetuximab for Claudin-18.2 positive gastric adenocarcinoma and the checkpoint inhibitor Tislelizumab for esophageal squamous cell carcinoma. For the treatment of relapsed or refractory hematologic B cell malignancies, the use of bispecific T cell engaging antibodies like the BCMA-CD3 targeting Teclistamab and CD20-CD3 targeting Glofitamab were approved by the EMA recently.Combinatorial approaches of conventional chemotherapy and checkpoint inhibitors for the treatment of cholangiocarcinoma, urothelial carcinoma and endometrial carcinoma received recent approval.A CD38 antibody-based bridging therapy for the treatment of newly diagnosed multiple myeloma and the Glofitamab-based approach in combination with Gemcitabine and Oxaliplatin for relapsed DLBCL are the latest additions for hematologic malignancies after promising clinical trials.The first T cell products for the treatment of solid cancers using either tumor-infiltrating lymphocytes or TCR-engineered peripheral blood T cells were approved by the FDA in 2024, for the treatment of advanced melanoma (Lifileucel) and synovial sarcoma (Afamitresgene autoleucel). To further expand the success of T cell products to solid tumors, promising preclinical studies suggest solutions to main obstacles, such as modular CAR T cells, targeting of two antigens simultaneously or generation of cytokine-secreting 4th generation CAR T cells.
    Review • Journal
    |
    CLDN18 (Claudin 18)
    |
    gemcitabine • Tevimbra (tislelizumab-jsgr) • oxaliplatin • Elahere (mirvetuximab soravtansine-gynx) • Vyloy (zolbetuximab-clzb) • Tecelra (afamitresgene autoleucel) • Tecvayli (teclistamab-cqyv) • Amtagvi (lifileucel) • Columvi (glofitamab-gxbm)
    1m
    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 | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Columvi (glofitamab-gxbm)