COLUMVI

(Glofitamab)

Phase 3Monoclonal antibody

Glofitamab is used to treat certain types of blood cancers, specifically a form of lymphoma called diffuse large B-cell lymphoma. It works by helping the body's immune system recognize and destroy cancer cells.[1] COLUMVI is currently being investigated across 19 indications[3], with its most advanced program in Phase 3.[1]

COLUMVI is one of 241 biologic programs targeting Non-Hodgkins Lymphoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

240

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Non-Hodgkins LymphomaActive, not recruiting

Central Nervous System LymphomaActive, not recruiting

LymphomaRecruiting

Richter SyndromeActive, not recruiting

B-Cell Non-Hodgkins LymphomaActive, not recruiting

Mantle Cell LymphomaActive, not recruiting

Diffuse Large B-Cell LymphomaActive, not recruiting

Multiple MyelomaActive, not recruiting

Chronic Lymphocytic LeukemiaActive, not recruiting

Lymphoma, B-CellActive, not recruiting

Non-Hodgkins LymphomaPhase 1

Active, not recruiting

Central Nervous System LymphomaPhase 1

Active, not recruiting

LymphomaPhase 3

Recruiting

Richter SyndromePhase 2

Active, not recruiting

B-Cell Non-Hodgkins LymphomaPhase 2

Active, not recruiting

Mantle Cell LymphomaPhase 2

Active, not recruiting

Diffuse Large B-Cell LymphomaPhase 3

Active, not recruiting

Multiple MyelomaPhase 1

Active, not recruiting

Chronic Lymphocytic LeukemiaPhase 2

Active, not recruiting

Lymphoma, B-CellPhase 1

Active, not recruiting

Showing 10 of 19 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

COLUMVI

Roche

Phase 3

23 2

Blenoxane

SSequus Pharmaceuticals

Preclinical

25 3

Oncaspar

SServier

Preclinical

15 4

Tafasitamab

Incyte

Preclinical

7 5

Nuvigil

NNuvo Research GmbH

Preclinical

1 6

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—7

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—8

CAR-T

HHebei Senlang Biotechnology Inc., Ltd.

Preclinical

3 9

Rhg-CSF

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Preclinical

3 10

VP-16

FFundamenta Therapeutics, Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Recruiting

Study completion

NCT06994169

Phase 2Not yet recruiting

First-Line

NCT07012980

Phase 2Active, not recruiting

Diffuse Large B-Cell Lymphoma

NCT04980222

Q4 2026

Phase 2Recruiting

Mantle Cell Lymphoma

NCT06054776

PreclinicalActive, not recruiting

Non-Hodgkins Lymphoma

NCT03533283

Phase 2Recruiting

Lymphoma

NCT06534437

Clinical

Trials by Indication[1]

Lymphoma23 trials

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

Recruiting· Roche logo

Roche·Phase 1/2·NCT03075696·940 enrolled

MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)

Recruiting·RRyvu Therapeutics SA·Phase 2·NCT06534437·178 enrolled

Bispecific Antibody-Based Salvage Therapy Followed by CAR-T ± ASCT in R/R Aggressive B-Cell Lymphoma

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06996132·25 enrolled

Show 20 more trials

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

Active, not recruiting· Roche logo

Roche·Phase 3·NCT06047080·1,130 enrolled

A Multicentre, Parallel Arm, Open-label Trial of Frontline R-CHOP/Pola-RCHP and Glofitamab in Younger, Higher Risk Patients With Diffuse Large B Cell Lymphoma (DLBCL)

Active, not recruiting·PPeter MacCallum Cancer Centre, Australia·Phase 1/2·NCT04914741·80 enrolled

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)

Recruiting·AADC Therapeutics S.A.·Phase 1·NCT04970901·200 enrolled

A Study of Efficacy and Safety of Glofitamab in Combination With Salvage Therapy in a Real-world Setting in Chinese Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.

Recruiting·TThe First Affiliated Hospital of Soochow University··NCT06497452·50 enrolled

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

Completed· Roche logo

Roche·Phase 1·NCT03467373·111 enrolled

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.

Active, not recruiting· Pfizer logo

Pfizer·Phase 1/2·NCT05896163·24 enrolled

Glofitamab as a Bridge to and/or Consolidation Post Autologous Stem Cell Transplant in Patients With Relapsed B Cell Lymphomas

Not yet recruiting·—·Phase 2·NCT07387848·40 enrolled

A Phase 2 Trial of Glofitamab for Minimal Residual Disease in Patients With Large B-cell Lymphoma

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT06670105

A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma.

Recruiting·AArvinas Inc.·Phase 1·NCT06393738·255 enrolled

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

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT07240194·24 enrolled

A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma

Recruiting·UUniversity College, London·Phase 2·NCT06071871·99 enrolled

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Terminated· Roche logo

Roche·Phase 1·NCT05219513·53 enrolled

CAR T-cell Therapy in Combination With Glofitamab for Relapsed/Refractory Large B-Cell Lymphoma With High-Risk Prognostic Factors

Not yet recruiting·RRuijin Hospital·Phase 2·NCT06567366·45 enrolled

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

Completed· Roche logo

Roche·Phase 1·NCT05364424·43 enrolled

Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma

Recruiting·UUniversity of Washington·Phase 1·NCT04231877·56 enrolled

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

Active, not recruiting· Roche logo

Roche·Phase 1/2·NCT04077723·498 enrolled

A Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06213311·40 enrolled

Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP

Active, not recruiting·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT05798156·125 enrolled

A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed/Refractory Mantle Cell Lymphoma

Recruiting· Roche logo

Roche·Phase 3·NCT06084936·182 enrolled

A Phase Ib Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Recruiting· Roche logo

Roche·Phase 1·NCT06624085·50 enrolled

Diffuse Large B-Cell Lymphoma10 trials

A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma

Recruiting·JJennifer Crombie, MD·Phase 2·NCT05800366·41 enrolled

A Study to Evaluate Glofitamab as Single Agent Administered After Pretreatment With Obinutuzumab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Completed· Roche logo

Roche·Phase 1·NCT04657302·30 enrolled

The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study

Not yet recruiting·RRuijin Hospital··NCT06656234·200 enrolled

Show 7 more trials

A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06765317·42 enrolled

Glofitamab in Relapsed or Refractory Diffuse Large B-cell Lymphoma After CD19 Chimeric Antigen Receptor T-cell Therapy

Active, not recruiting·SSamsung Medical Center·Phase 2·NCT06552572·30 enrolled

Efficacy and Safety of Glofitamab Combined With GemOxin the Treatment of Refractory Diffuse Large B-Cell Lymphoma

Active, not recruiting·—·Phase 2·NCT07480850·40 enrolled

A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma

Completed· Roche logo

Roche·Phase 1·NCT04313608·23 enrolled

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

Active, not recruiting· Roche logo

Roche·Phase 2·NCT04980222·46 enrolled

A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04408638·270 enrolled

Evaluating Effectiveness and Safety of Glofitamab Based Second-Line Therapy in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter, Cohort Study

Recruiting· Roche logo

Roche··NCT07200375·300 enrolled

Mantle Cell Lymphoma9 trials

Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma

Recruiting·PPeking University Third Hospital·Phase 2·NCT07460362·43 enrolled

A Prospective, Single-Center Study Evaluating the Efficacy and Safety of Glofitamab Combined With Orelabrutinib and Bortezomib in Patients With High-Risk Mantle Cell Lymphoma

Not yet recruiting·RRuijin Hospital·Phase 2·NCT06656221·29 enrolled

Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Recruiting·UUniversity of California, San Francisco·Phase 2·NCT06252675·30 enrolled

Show 6 more trials

A Phase 2 Trial of GlOfitamab anD pIrtobrutinib in Mantle Cell Lymphoma Patients With Prior BTK Inhibitor Exposure.

Recruiting·AAustralasian Leukaemia and Lymphoma Group·Phase 2·NCT05833763·42 enrolled

Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma

Recruiting·—·Phase 1/2·NCT05861050·50 enrolled

Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial

Recruiting·OOHSU Knight Cancer Institute·Phase 1/2·NCT06357676·27 enrolled

Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Recruiting·—·Phase 2·NCT06054776·40 enrolled

A Study of Glofitamab and Lenalidomide in People With Mantle Cell Lymphoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT06192888·39 enrolled

A Phase II, Multicenter Study of GlOfitamab in Patients With Mantle Cell Lymphoma and inaDequate Response or Relapse Following CAR T-cell Therapy (GOLD)

Recruiting·FFondazione Italiana Linfomi - ETS·Phase 2·NCT07453095·41 enrolled

DLBCL3 trials

Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL (GRAIL)

Recruiting·UUniversity Health Network, Toronto·Phase 2·NCT06050694·40 enrolled

Glofitamab in Chinese Patients With R/R DLBCL

Recruiting·PPeking Union Medical College Hospital··NCT06481826·20 enrolled

Glofitamab Combined With CAR-T Therapy in R/R DLBCL

Not yet recruiting·RRuijin Hospital·Phase 2·NCT07326371·24 enrolled

Richter's Transformation1 trial

Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation

Recruiting·CChristine Ryan·Phase 2·NCT06043674·70 enrolled

18 more indications

High Risk1 trial

Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WINDOW-4 Study

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07257055·30 enrolled

First-line1 trial

Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL

Not yet recruiting·SShanghai Zhongshan Hospital·Phase 2·NCT07012980·38 enrolled

CAR-T1 trial

CAR-T Followed by Bispecific Antibodies

Recruiting·—·Phase 2·NCT04889716·42 enrolled

Follicular Lymphoma1 trial

Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma

Active, not recruiting·—·Phase 2·NCT05783596·47 enrolled

Refractory1 trial

Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL

Recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT06570447·22 enrolled

Diffuse Large B-cell Lymphoma(DLBCL)1 trial

An Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Standard of Care in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Not yet recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT07599423·96 enrolled

Recurrent Mantle Cell Lymphoma1 trial

A Phase II Study of Glofitamab for Relapsed/Refractory Mantle Cell Lymphoma in Patients Previously Treated With CD19-Directed CAR T-Cell Therapy

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07003295·20 enrolled

B-cell Malignancy1 trial

A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies

Recruiting·BBeOne Medicines·Preclinical·NCT06634589·80 enrolled

Refractory B-Cell Non-Hodgkin Lymphoma1 trial

A Real-World Study on the Efficacy and Safety of Bispecific Antibody in the Treatment of Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Not yet recruiting·YYanyan Liu··NCT07695896·200 enrolled

Lymphoma, Mantle-Cell1 trial

A Phase II, Multicenter, Open-label Study Evaluating Glofitamab in Combination With Venetoclax Plus Zanubrutinib or Venetoclax Alone in Subjects With Untreated or Relapsed/Refractory High-risk Mantle-cell Lymphoma

Recruiting·TThe Lymphoma Academic Research Organisation·Phase 2·NCT06558604·100 enrolled

Ann Arbor Stage II Mantle Cell Lymphoma1 trial

A Phase I Study of Glofitamab With Alternating R-CHOP/R-DHAP in Previously Untreated Mantle Cell Lymphoma

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT07444710·16 enrolled

AIDS-Related Diffuse Large B-cell Lymphoma1 trial

A Feasibility Study of Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT07649304·15 enrolled

Primary Central Nervous System Lymphoma1 trial

A Phase 1b Study of Glofitamab in CNS Lymphoma

Suspended·CCity of Hope Medical Center·Phase 1·NCT06922604·20 enrolled

Non-Hodgkins Lymphoma1 trial

An Open-Label, Multi-Center, Phase IB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin (Plus a Single Pre-Treatment Dose of Obinutuzumab) in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Active, not recruiting· Roche logo

Roche·Preclinical·NCT03533283·211 enrolled

Mature B-Cell Non-Hodgkin Lymphoma1 trial

A Phase I/II, Open-Label, Single-Arm, Two-Part Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Glofitamab in Monotherapy and in Combination With Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma

Recruiting· Roche logo

Roche·Preclinical·NCT05533775·65 enrolled

Lymphoma, B-Cell1 trial

A Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma

Active, not recruiting·CCanadian Cancer Trials Group·Phase 1·NCT04161248·40 enrolled

B-cell non-Hodgkins lymphoma1 trial

A Phase II, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Recruiting· Roche logo

Roche·Phase 2·NCT06806033·100 enrolled

Unspecified1 trial

Glofitamab in Real Life

Recruiting·TThe Lymphoma Academic Research Organisation··NCT06994169·250 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 15, 2023

COLUMVI

BLA BLA761309

Sources

References

[1]
ClinicalTrials.gov — 64 trial records for Glofitamab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Glofitamab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Glofitamab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761309). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: B-Lymphocyte Antigen CD20 Binding Agent; T Cell Surface Glycoprotein CD3 Binding Agent[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Roche

COLUMVI

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Lymphoma23 trials

Diffuse Large B-Cell Lymphoma10 trials

Mantle Cell Lymphoma9 trials

DLBCL3 trials

Richter's Transformation1 trial

High Risk1 trial

First-line1 trial

CAR-T1 trial

Follicular Lymphoma1 trial

Refractory1 trial

Diffuse Large B-cell Lymphoma(DLBCL)1 trial

Recurrent Mantle Cell Lymphoma1 trial

B-cell Malignancy1 trial

Refractory B-Cell Non-Hodgkin Lymphoma1 trial

Lymphoma, Mantle-Cell1 trial

Ann Arbor Stage II Mantle Cell Lymphoma1 trial

AIDS-Related Diffuse Large B-cell Lymphoma1 trial

Primary Central Nervous System Lymphoma1 trial

Non-Hodgkins Lymphoma1 trial

Mature B-Cell Non-Hodgkin Lymphoma1 trial

Lymphoma, B-Cell1 trial

B-cell non-Hodgkins lymphoma1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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