COLUMVI (glofitamab-gxbm)
COLUMVI is indicated for the treatment of Diffuse Large B-Cell Lymphoma; Follicular Lymphoma.
How COLUMVI Works
Glofitamab-gxbm is a bispecific antibody that binds to CD20 expressed on the surface of B cells and the CD3 receptor expressed on the surface of T cells. This dual binding causes T-cell activation and proliferation as well as the secretion of cytokines. These actions result in the lysis of CD20-expressing B cells. The drug has demonstrated anti-tumor activity in vivo in models of diffuse large B-cell lymphoma.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-06-15
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
COLUMVI Approval History
What COLUMVI Treats
2 indicationsCOLUMVI is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diffuse Large B-Cell Lymphoma
- Follicular Lymphoma
COLUMVI Boxed Warning
CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.2 , 2.3 , and 2.4) and Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME See full prescribing inform...
WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.2 , 2.3 , and 2.4) and Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.2 , 2.3 , 2.4 , 5.1 )
COLUMVI Target & Pathway
ProTarget
A protein found on the surface of B-cells but not stem cells or plasma cells. Anti-CD20 antibodies deplete B-cells, making them effective in B-cell cancers and autoimmune diseases where B-cells drive pathology.
COLUMVI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in COLUMVI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications COLUMVI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to COLUMVI
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
59 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07003295 | NCI-2025-03915 NCI-2025-03915, 10702 | Ph 2 | recruiting | 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 |
| NCT07444710 | NCI-2026-01137 NCI-2026-01137, PHI-158 | Ph 1 | not yet recruiting | Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma |
| NCT06634589 | BGB-16673-104 2024-516234-35-00, CTR20244676 | Ph 1, Ph 2 | recruiting | A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies |
| NCT05896163 MAPtivate-6 | C4971006 2022-502822-41-00 | Ph 1, Ph 2 | terminated | A Study to Learn About the Effects of Two Study Medicines (Maplirpacept [PF-07901801] And Glofitamab) When Given Together In People With Relapsed Or Refractory Diffuse Large B Cell Lymphoma. |
| NCT05533775 iMATRIX GLO | CO43810 | Ph 1, Ph 2 | recruiting | A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma |
| NCT06084936 GLOBRYTE | GO43878 | Ph 3 | recruiting | A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma |
| NCT06624085 | GO44900 | Ph 1 | recruiting | A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
| NCT03075696 | NP30179 2016-001185-28, 2023-505625-14-00 | Ph 1, Ph 2 | active not recruiting | A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma |
| NCT06765317 | 24-332 | Ph 2 | recruiting | A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma |
| NCT06806033 | GO45434 | Ph 2 | recruiting | A Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma |
| NCT06050694 GRAIL | OZM-121 | Ph 2 | recruiting | Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL (GRAIL) |
| NCT06252675 | 232516 NCI-2024-00054 | Ph 2 | recruiting | Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma |
| NCT07528352 REBEL | HCI198128 | Ph 1 | not yet recruiting | External Beam Radiotherapy Followed by Bispecific Antibody Therapy for Relapsed/Refractory DLBCL |
| NCT07453095 | FIL_GOLD | Ph 2 | not yet recruiting | Study With Glofitamab in Patients With MCL and Inadequate Response or Relapse Following CAR T-cell Therapy |
| NCT07257055 | 2025-0423 NCI-2025-08762 | Ph 2 | recruiting | Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WINDOW-4 Study |
| NCT05798156 R-Pola-Glo | R-Pola-Glo ML44400, 2022-003398-51 | Ph 2 | active not recruiting | Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP |
| NCT04408638 | GO41944 2020-001021-31 | Ph 3 | active not recruiting | A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma |
| NCT03533283 | NP39488 | Ph 1, Ph 2 | active not recruiting | An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma |
| NCT07502872 TPG | BrUOG-450 ML46671, I-000585-25-02 | Ph 2 | not yet recruiting | TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma |
| NCT06192888 | 23-319 | Ph 1 | active not recruiting | A Study of Glofitamab and Lenalidomide in People With Mantle Cell Lymphoma |
| NCT04889716 | UPCC 48420 | Ph 2 | recruiting | CAR-T Followed by Bispecific Antibodies |
| NCT07480850 | NCCH0050 | Ph 2 | active not recruiting | Efficacy and Safety of Glofitamab Combined With GemOxin the Treatment of Refractory Diffuse Large B-Cell Lymphoma |
| NCT06047080 | GO44145 | Ph 3 | active not recruiting | An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma |
| NCT05783596 | 22-632 | Ph 2 | active not recruiting | Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma |
| NCT04970901 | ADCT-402-105 2021-001071-16 | Ph 1 | recruiting | A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7) |
| NCT07460362 | ML45833 | Ph 2 | recruiting | Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma |
| NCT05800366 | 22-606 | Ph 2 | recruiting | A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma |
| NCT04231877 | RG1006477 NCI-2019-08983, 10423 | Ph 1 | recruiting | Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma |
| NCT04077723 | BP41072 2019-000416-28, 2022-502616-37-00 | Ph 1, Ph 2 | active not recruiting | A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma |
| NCT05861050 | 22685 NCI-2023-03181, 22685 | Ph 1, Ph 2 | recruiting | Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma |
| NCT04980222 | GO43075 2023-504994-19-00 | Ph 2 | active not recruiting | 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 |
| NCT06558604 GLOASIS | GLOASIS | Ph 2 | recruiting | Phase II Study of Glofitamab With Venetoclax +/- Zanubrutinib in High-risk Mantle-cell Lymphoma |
| NCT06393738 | ARV-393-101 2023-510136-36-00 | Ph 1 | recruiting | A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma. |
| NCT07387848 GLO-PACT | BIO-2025-0317 | Ph 2 | not yet recruiting | Glofitamab as a Bridge to and/or Consolidation Post Autologous Stem Cell Transplant in Patients With Relapsed B Cell Lymphomas |
| NCT06357676 | STUDY00025355 NCI-2024-01208, STUDY00025355 | Ph 1, Ph 2 | recruiting | Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial |
| NCT06213311 | 2023-0673 NCI-2024-00209 | Ph 2 | recruiting | A Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma |
| NCT07326371 | Glofit_peri_CART | Ph 2 | not yet recruiting | Glofitamab Combined With CAR-T Therapy in R/R DLBCL |
| NCT06043674 | 23-429 | Ph 2 | recruiting | Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation |
| NCT06054776 | 22402 NCI-2023-06838, 22402 | Ph 2 | recruiting | Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma |
| NCT05364424 | GO43693 | Ph 1 | completed | 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 |
| NCT07240194 | 2025-SR-499 | Ph 2 | recruiting | 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 |
| NCT06922604 | 24487 NCI-2025-02019, 24487 | Ph 1 | recruiting | Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma |
| NCT06534437 JASPIS-01 | JASPIS-01 | Ph 2 | recruiting | MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01) |
| NCT06670105 | 2024-1314 NCI-2024-09090, NCI-2025-06734 | Ph 2 | withdrawn | A Phase 2 Trial of Glofitamab for Minimal Residual Disease in Patients With Large B-cell Lymphoma |
| NCT06996132 | IIT2025054 | Ph 2 | recruiting | Bispecific Antibody-Based Salvage Therapy Followed by CAR-T ± ASCT in R/R Aggressive B-Cell Lymphoma |
| NCT07012980 | SHZS-DLBCL004 | Ph 2 | not yet recruiting | Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL |
| NCT06552572 Glory | MO44989 | Ph 2 | active not recruiting | Glofitamab in Relapsed or Refractory Diffuse Large B-cell Lymphoma After CD19 Chimeric Antigen Receptor T-cell Therapy |
| NCT06570447 | GTC-RR-DLBCL01 | Ph 2 | recruiting | Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL |
| NCT03467373 | NP40126 2017-003648-18 | Ph 1 | completed | A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL |
| NCT06071871 PORTAL | UCL/150862 2022-003727-17 | Ph 2 | recruiting | A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma |
Showing 50 of 59 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
COLUMVI FDA Label Details
Indications & Usage
FDA Label (PDF)COLUMVI is indicated for the treatment of Diffuse Large B-Cell Lymphoma; Follicular Lymphoma.
WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resol...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment