glofitamab
Trade name: Columvi
mAbapprovedMulti-specificFast Track FDA
Approved
Jun 15, 2023
Clinical trial activity
55 trials · 44 clinical orgs · 2 marketing orgs
Phase 1
15
Phase 2
42
Phase 3
3
Phase 4
1
Earliest trial started Feb 21, 2017 (NCT03075696)
Timeline
Indications
Studied for
- Antibodies, Monoclonal · Phase 2
- Drugs, Investigational · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Lymphoma · Phase 3
- Lymphoma, B-Cell · Phase 4
- Lymphoma, B-Cell, Marginal Zone · Phase 2
- Lymphoma, Follicular · Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 3
- Lymphoma, Large-Cell, Immunoblastic · Phase 3
- Lymphoma, Mantle-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Medial Collateral Ligament, Knee · Phase 1
- Tumor Suppressor Protein p53 · Phase 2
Mechanism of action
CD3E activator
- B-lymphocyte antigen CD20BINDING AGENT
MS4A1 binding agent
- T cell surface glycoprotein CD3BINDING AGENT
T cell surface glycoprotein CD3 binding agent
Directs cytotoxic T-cells to tumours
Approval history
- approvedPriority reviewAcceleratedFast trackJun 15, 2023
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- Yes
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- ChEMBLCHEMBL4298092 ↗
Also known as
- ro7082859
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07257055 | Phase 2 | May 12, 2026 | University of Texas at Houston |
| NCT07231250 | Phase 2 | Jan 15, 2026 | Sun Yat-Sen University |
| NCT07003295 | Phase 2 | Oct 31, 2025 | Johns Hopkins University, National Cancer Institute (NCI) |
| NCT07184788 | Phase 2 | Oct 1, 2025 | Government of China |
| NCT07240194 | Phase 2 | Sep 1, 2025 | Nanjing Medical University |
| NCT06922604 | Phase 1 | Jul 30, 2025 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT07012980 | Phase 2 | Jun 1, 2025 | BeOne Medicines, Fudan University, Roche |
| NCT06956092 | Phase 4 | May 30, 2025 | Zhengzhou University |
| NCT06996132 | Phase 2 | May 9, 2025 | China Academy of Chinese Medical Sciences |
| NCT06867536 | Phase 2 | Apr 1, 2025 | Huazhong University of Science and Technology |
| NCT06806033 | Phase 2 | Mar 5, 2025 | Roche |
| NCT06665217 | Phase 2 | Jan 31, 2025 | Government of China |
| NCT06765317 | Phase 2 | Jan 16, 2025 | Genentech, Memorial Sloan-Kettering Cancer Center |
| NCT06670105 | Phase 2 | Jan 6, 2025 | Genentech, University of Texas at Houston |
| NCT06558604 | Phase 2 | Dec 31, 2024 | BeOne Medicines, Curie Institute, Roche, The Lymphoma Academic Research Organisation |
| NCT06656221 | Phase 2 | Dec 1, 2024 | Jiao Tong University |
| NCT06534437 | Phase 2 | Nov 30, 2024 | Menarini Group, Selvita S.A. |
| NCT06624085 | Phase 1 | Nov 15, 2024 | Roche |
| NCT06651853 | Phase 2 | Oct 21, 2024 | Xiamen University |
| NCT06567366 | Phase 2 | Sep 30, 2024 | Jiao Tong University |
Showing 20 of 55 trials
Page 1 / 3
Organizations
Research & Development (44)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Roche | For profit | 23 | 16 | 4 | 2017 |
| Genentech | For profit | 10 | 0 | 2 | 2021 |
| National Cancer Institute (NCI) | Government | 4 | 1 | 2 | 2023 |
| City of Hope National Medical Center | Academic/Hospital | 3 | 3 | 2 | 2023 |
| Harvard University | Academic/Hospital | 3 | 3 | 1 | 2023 |
| University of Texas at Houston | Academic/Hospital | 3 | 3 | 1 | 2024 |
| BeOne Medicines | For profit | 2 | 0 | 1 | 2024 |
| Government of China | Government | 2 | 2 | 1 | 2025 |
| Jiao Tong University | Academic/Hospital | 2 | 2 | 1 | 2024 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 2 | 2 | 2 | 2024 |
| The Lymphoma Academic Research Organisation | Academic/Hospital | 2 | 2 | 1 | 2021 |
| Adaptive Biotechnologies | For profit | 1 | 0 | 1 | 2024 |
| Arbeitsgemeinschaft medikamentoese Tumortherapie | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Australasian Leukaemia and Lymphoma Group | Academic/Hospital | 1 | 1 | 1 | 2023 |
| China Academy of Chinese Medical Sciences | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Curie Institute | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Eli Lilly | For profit | 1 | 0 | 1 | 2024 |
| French Innovative Leukemia Organisation | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Fudan University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Gilead Sciences | For profit | 1 | 0 | 1 | 2024 |
44 organizations
Page 1 / 3