mosunetuzumab
Trade name: Lunsumio
mAbapprovedMulti-specificOrphan Drug FDABreakthrough Therapy FDA
Approved
Dec 22, 2022
Clinical trial activity
47 trials · 34 clinical orgs · 2 marketing orgs
Phase 1
17
Phase 2
36
Phase 3
5
Phase 4
0
Earliest trial started Sep 30, 2015 (NCT02500407)
Timeline
Indications
Approved for
Studied for
- Hodgkin Disease · Phase 2
- Leukemia · Phase 1/Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Lupus Erythematosus, Systemic · Phase 1
- Lymphoma · Phase 2
- Lymphoma, B-Cell · Phase 2
- Lymphoma, B-Cell, Marginal Zone · Phase 3
- Lymphoma, Follicular · Phase 3
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Lymphoma, Non-Hodgkin · Phase 3
- Neoplasms · Phase 1/Phase 2
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 1
Mechanism of action
CD3E agonist
- T cell surface glycoprotein CD3BINDING AGENT
T cell surface glycoprotein CD3 binding agent
Directs cytotoxic T-cells to tumours
- B-lymphocyte antigen CD20BINDING AGENT
B-lymphocyte antigen CD20 binding agent
Directs cytotoxic T-cells to tumours
- B-lymphocyte antigen CD20Immunity, passive
MS4A1 immunity, passive
Approval history
- approvedPriority reviewAcceleratedBreakthroughDec 22, 2022
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 warningFirst in class
Sources
- ChEMBLCHEMBL4297788 ↗
Also known as
- btct4465a
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07052695 | Phase 1/Phase 2 (Phase 2) | Nov 30, 2025 | Genentech, Harvard University |
| NCT06948786 | Phase 2 | Nov 17, 2025 | Eli Lilly, University of Washington |
| NCT07191249 | Phase 2 | Oct 10, 2025 | Roche, Tel Aviv University |
| NCT07031700 | Phase 2 | Jul 1, 2025 | Tianjin Medical University |
| NCT06828991 | Phase 2 | Apr 1, 2025 | Adaptive Biotechnologies, Genentech, Lymphoma Research Foundation, University of Rochester |
| NCT06563505 | Phase 2 | Dec 31, 2024 | University of Texas at Houston |
| NCT06594939 | Phase 2 | Dec 31, 2024 | Medical College of Wisconsin |
| NCT06569680 | Phase 2 | Dec 1, 2024 | Genentech, University of Miami |
| NCT06337318 | Phase 3 | Oct 23, 2024 | National Cancer Institute (NCI), SWOG Cancer Research Network |
| NCT06492837 | Phase 2 | Sep 15, 2024 | Gruppo Italiano Studio Linfomi |
| NCT06453044 | Phase 2 | Sep 9, 2024 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT06015880 | Phase 1 | Sep 3, 2024 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT06442475 | Phase 2 | Aug 29, 2024 | University of Washington |
| NCT05886036 | Phase 2 | Jul 27, 2024 | National Cancer Institute (NCI), University of Texas at Houston |
| NCT06249191 | Phase 1/Phase 2 (Phase 2) | Jun 13, 2024 | Genentech, OHSU Knight Cancer Institute, Oregon Health and Science University |
| NCT06284122 | Phase 3 | Jun 7, 2024 | Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea, Swiss Cancer Institute, Swiss Group for Clinical Cancer Research, The Lymphoma Academic Research Organisation, The Lymphoma Study Association |
| NCT06926205 | Phase 2 | May 15, 2024 | Evidenze Health España (CRO), Grupo Español de Leucemia Linfocítica Crónica (GELLC) |
| NCT06521996 | Phase 2 | Apr 26, 2024 | Grupo Español de Leucemia Linfocítica Crónica (GELLC) |
| NCT05672251 | Phase 2 | Dec 28, 2023 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT05994235 | Phase 2 | Nov 1, 2023 | Cornell University, Epizyme, Inc., Genentech |
Showing 20 of 47 trials
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Organizations
Research & Development (34)
34 organizations
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