Glofitamab clinical trials
Glofitamab is named as an intervention in 48 current clinical trials in our China, USA, France, Spain, Australia, Italy, Canada, UK, Poland, Denmark, South Korea, Germany, Belgium, Israel, Taiwan, Brazil, Czechia, Switzerland, Sweden, Turkey, Mexico, Japan, Netherlands and Austria registers. 22 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Hoffmann-La Roche (11). The most-studied condition is Lymphoma.
Where Glofitamab is approved
All regulators →Of the three regulators tracked here, the first to approve Glofitamab was Canada, on 24 Mar 2023. It is approved in 3 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for treatment of mantle cell lymphoma (13 Apr 2022, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Glofitamab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Glofitamab works
All drug targets →- B-lymphocyte antigen CD20 binding agent Binding agentTarget: MS4A1 membrane spanning 4-domains A1✓ In ChEMBL and the Guide to Pharmacology
- T cell surface glycoprotein CD3 binding agent Binding agentTarget: T cell surface glycoprotein CD3ChEMBL only
- Mantle cell lymphomaPhase 3
- B-cell chronic lymphocytic leukemiaPhase 2
- B-cell non-Hodgkin lymphomaPhase 2
- Richter transformationPhase 2
- Follicular lymphomaPhase 2
- High grade B-cell lymphomaPhase 2
- Marginal zone lymphomaPhase 2
- Non-Hodgkin lymphomaPhase 2
- Burkitt lymphomaPhase 1
- Primary central nervous system lymphomaPhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4298092, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 12758, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Glofitamab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Glofitamab. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Glofitamab with gemcitabine and oxaliplatin for treating relapsed or refractory diffuse large B-cell lymphoma NICE TA1113 | Optimised | 3 Dec 2025 | Current |
| Glofitamab for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic treatments NICE TA927 | Recommended | 17 Oct 2023 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Glofitamab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: ColumviEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Glofitamab
48 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Glofitamab across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
2 single-substance products containing Glofitamab on the HPRA medicines list.
- Columvi 10 mg concentrate for solution for infusionRoche Registration GmbH · EU/1/23/1742/002
- Columvi 2.5 mg concentrate for solution for infusionRoche Registration GmbH · EU/1/23/1742/001
Supply shortages
No entry for Glofitamab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Glofitamab
53 conditionsAll 53 conditions
| Condition (as registered) | Trials |
|---|---|
| Lymphoma | 6 |
| Large B-cell Lymphoma | 5 |
| Large B-Cell Lymphoma (LBCL) | 3 |
| Diffuse Large B Cell Lymphoma (DLBCL) | 3 |
| Diffuse Large B-Cell Lymphoma | 2 |
| DLBCL - Diffuse Large B Cell Lymphoma | 2 |
| Lymphoma, Large B-Cell, Diffuse | 2 |
| Mantle Cell Lymphoma | 2 |
| Non-Hodgkin Lymphoma, B-cell | 1 |
| Diffuse Large B-cell Lymphoma | 1 |
| B-Cell Non-Hodgkin Lymphoma | 1 |
| Relapsed B-Cell Non-Hodgkin Lymphoma | 1 |
| Refractory B-Cell Non-Hodgkin Lymphoma | 1 |
| Non-Hodgkin Lymphoma | 1 |
| Lymphoma, Non-Hodgkin | 1 |
| Large B-Cell Lymphoma | 1 |
| B-cell Malignancy | 1 |
| Relapsed Cancer | 1 |
| Refractory Cancer | 1 |
| B-cell Lymphoma | 1 |
| Relapsed/Refractory (R/R) Mature B Cell Non Hodgkin Lymphoma (NHL) | 1 |
| Relapsed/Refractory (R/R) Angioimmunoblastic T-cell Lymphoma (AITL) | 1 |
| Non-Hodgkin's Lymphoma | 1 |
| Mature B-Cell Non-Hodgkin Lymphoma | 1 |
| Relapsed or Refractory Aggressive B-Cell Non-Hodgkins Lymphoma | 1 |
| Relapsed/Refractory Large B-cell Lymphoma (LBCL) | 1 |
| Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | 1 |
| Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma | 1 |
| MCL | 1 |
| Relapsed or Refractory Mantle Cell Lymphoma (MCL) | 1 |
| Relapsed or Refractory Aggressive B-cell Lymphoma | 1 |
| Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | 1 |
| Diffuse Large B-Cell Lymphoma-Recurrent | 1 |
| Diffuse Large B-Cell Lymphoma-Refractory | 1 |
| PCNSL (Primary CNS Lymphoma) | 1 |
| Central Nervous System Lymphoma | 1 |
| Secondary Central Nervous System Lymphoma (SCNSL) | 1 |
| Chemo-free Therapy | 1 |
| Bispecific Antibody | 1 |
| TP53 | 1 |
| Diffuse Large B-Cell Lymphoma (DLBCL) | 1 |
| High-grade B-cell Lymphoma | 1 |
| Richter Syndrome | 1 |
| Lymphoma, Mantle-Cell | 1 |
| Lymphoma, B-Cell | 1 |
| Diffuse Large B Cell Lymphoma | 1 |
| Relapsed /Refractory DLBCL | 1 |
| Mantle Cell Lymphoma Refractory | 1 |
| Follicular Lymphoma | 1 |
| Marginal Zone Lymphoma | 1 |
| Indolent Non-hodgkin Lymphoma | 1 |
| B-cell Lymphomas | 1 |
| Relapsed/Refractory Large B-cell Lymphoma | 1 |
Sponsors
lead sponsor per trial+ 15 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Glofitamab trials
How many clinical trials are testing Glofitamab?
48 current trials in our China, USA, France, Spain, Australia, Italy, Canada, UK, Poland, Denmark, South Korea, Germany, Belgium, Israel, Taiwan, Brazil, Czechia, Switzerland, Sweden, Turkey, Mexico, Japan, Netherlands and Austria registers name Glofitamab (also registered as RO7082859) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Glofitamab trials recruiting patients?
Yes. 22 of the 48 trials are recruiting: 11 with sites in China, 5 with sites in USA, 7 with sites in France, 4 with sites in Spain, 6 with sites in Australia, 5 with sites in Italy, 4 with sites in Canada, 2 with sites in UK, 3 with sites in Poland, 2 with sites in Denmark, 3 with sites in South Korea, 3 with sites in Germany, 1 with sites in Belgium, 2 with sites in Israel, 1 with sites in Taiwan, 3 with sites in Brazil, 1 with sites in Czechia and 1 with sites in Sweden. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Glofitamab clinical trials?
Hoffmann-La Roche (11), Ruijin Hospital (6), The First Affiliated Hospital of Soochow University (2) and The First Affiliated Hospital with Nanjing Medical University (2), among 30 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Glofitamab licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Glofitamab, for example Columvi 10 mg concentrate for solution for infusion (Roche Registration GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Glofitamab shortage?
Not in the lists we track: Glofitamab has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Glofitamab works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Glofitamab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Glofitamab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.