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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:
17h
CCTG LY18-A: Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma (clinicaltrials.gov)
P1, N=18, Recruiting, Canadian Cancer Trials Group | Trial completion date: Jul 2026 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date
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Venclexta (venetoclax) • cisplatin • gemcitabine • dexamethasone • Rituxan Hycela (rituximab/hyaluronidase) • Monjuvi (tafasitamab-cxix) • Columvi (glofitamab-gxbm)
2d
Enrollment open
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TP53 (Tumor protein P53) • CD20 (Membrane Spanning 4-Domains A1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CCND1 (Cyclin D1) • KMT2D (Lysine Methyltransferase 2D) • NOTCH2 (Notch 2) • PAX5 (Paired Box 5) • CD4 (CD4 Molecule) • CD5 (CD5 Molecule) • SOX11 (SRY-Box Transcription Factor 11) • NSD2 (Nuclear Receptor Binding SET Domain Protein 2)
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TP53 mutation • Chr del(17p) • Chr t(11;14) • CDKN2A deletion
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Imbruvica (ibrutinib) • Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm)
3d
New trial
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cisplatin • gemcitabine • dexamethasone • Columvi (glofitamab-gxbm)
3d
Immuno and targeted therapy for Richter transformation to diffuse large B-cell lymphoma (ChiCTR2500109894)
P2, N=34, Not yet recruiting, The FIrst Affiliated Hospital, College of Medicine, Zhejiang University; The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
New P2 trial
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CD20 (Membrane Spanning 4-Domains A1) • PD-1 (Programmed cell death 1)
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CD20 positive
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lenalidomide • Tevimbra (tislelizumab-jsgr) • Gazyva (obinutuzumab) • Brukinsa (zanubrutinib) • Columvi (glofitamab-gxbm)
18d
T-cell engaging antibodies for B-cell lymphomas. (PubMed, Semin Hematol)
This review focused on 4 CD20 × CD3 BsAbs, as well as surovatamig, a CD19 × CD3 BsAb currently under investigation that has demonstrated promising efficacy against relapsed/refractory B-cell lymphomas. All 4 CD20 × CD3 BsAbs are approved as third-line and beyond therapies: mosunetuzumab for follicular lymphoma (FL), glofitamab for diffuse large B-cell lymphoma (DLBCL), and epcoritamab and odronextamab for both FL and DLBCL (the latter in European Union only)...Multiple studies are currently evaluating these agents in both the relapsed/refractory and frontline settings, either as monotherapy or in combination with other agents. This review summarizes the efficacy and safety of each agent across B-cell lymphoma subtypes, along with their dosing schedules and CRS mitigation strategies.
Journal
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CD20 (Membrane Spanning 4-Domains A1)
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Epkinly (epcoritamab-bysp) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm) • Ordspono (odronextamab) • surovatamig (AZD0486)
20d
Glofitamab in Real Life (clinicaltrials.gov)
P=N/A, N=250, Recruiting, The Lymphoma Academic Research Organisation | Not yet recruiting --> Recruiting | Trial completion date: Nov 2026 --> Jul 2026 | Initiation date: Aug 2025 --> Dec 2025 | Trial primary completion date: Nov 2025 --> Mar 2026
Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
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Columvi (glofitamab-gxbm)
25d
New P2 trial
|
TP53 (Tumor protein P53)
|
TP53 mutation
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Gazyva (obinutuzumab) • Yescarta (axicabtagene ciloleucel) • Carteyva (relmacabtagene autoleucel) • Columvi (glofitamab-gxbm)
27d
Trial completion date • Trial primary completion date
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gemcitabine • Rituxan (rituximab) • Gazyva (obinutuzumab) • oxaliplatin • Actemra IV (tocilizumab) • Columvi (glofitamab-gxbm)
1m
Development and biomarkers of CD20/CD3 bispecific antibodies in diffuse large B-cell lymphoma. (PubMed, J Clin Exp Hematop)
BsAbs targeting CD20/CD3, such as epcoritamab, glofitamab, mosunetuzumab, and odronextamab, are rapidly progressing toward widespread clinical application. Although monotherapy remains the standard approach, clinical trials are exploring earlier-line use and combination strategies to further enhance outcomes. Particular attention is given to predictive biomarkers of response and mechanisms of resistance, including target antigen loss, tumor histology, prior therapies, intratumoral and peripheral T-cell status, and the emerging role of minimal residual disease monitoring.
Review • Journal
|
CD20 (Membrane Spanning 4-Domains A1)
|
Epkinly (epcoritamab-bysp) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm) • Ordspono (odronextamab)
2ms
Enrollment closed
|
CD20 (Membrane Spanning 4-Domains A1)
|
CD20 positive
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Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • prednisone • Polivy (polatuzumab vedotin-piiq) • Columvi (glofitamab-gxbm)
2ms
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)
2ms
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)
|
lenalidomide • Epkinly (epcoritamab-bysp) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm)