tafasitamab
Trade name: Monjuvi
mAbapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA
Approved
Jul 31, 2020
Clinical trial activity
47 trials · 41 clinical orgs · 1 marketing orgs
Phase 1
15
Phase 2
40
Phase 3
5
Phase 4
0
Earliest trial started Apr 1, 2013 (NCT01685021)
Timeline
2010s
Indications
Studied for
- Autoimmune Diseases · Phase 1/Phase 2
- Graft vs Host Disease · Phase 1
- Hematologic Neoplasms · Phase 2
- Hodgkin Disease · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia, Lymphoid · Phase 1/Phase 2
- Leukemia, Myeloid, Acute · Phase 1/Phase 2
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative · Phase 2
- Leukemia, Prolymphocytic · Phase 2
- Lupus Erythematosus, Systemic · Phase 1/Phase 2
- Lupus Nephritis · Phase 1/Phase 2
- 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 3
- Lymphoma, Large-Cell, Immunoblastic · Phase 3
- Lymphoma, Mantle-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 2
- Lymphoma, T-Cell · Phase 2
- Lymphoproliferative Disorders · Phase 2
- Medial Collateral Ligament, Knee · Phase 2
- Neoplasms · Phase 1/Phase 2
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Purpura, Thrombocytopenic, Idiopathic · Phase 2
- Scleroderma, Systemic · Phase 1/Phase 2
- Transplants · Phase 2
Mechanism of action
- B-lymphocyte antigen CD19BINDING AGENT
B-lymphocyte antigen CD19 binding agent
Antibody mediated B-cell lysis through apoptosis and immune effector mechanisms
CD19
Approval history
- approvedPriority reviewAcceleratedFast trackBreakthroughJul 31, 2020
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- ChEMBLCHEMBL4298047 ↗
Also known as
- mor00208
- mor208
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07225439 | Phase 1 | Dec 31, 2025 | Case Western Reserve University, Incyte |
| NCT07104565 | Phase 2 | Dec 10, 2025 | Incyte |
| NCT07030699 | Phase 2 | Aug 13, 2025 | Genmab, Incyte, Memorial Sloan-Kettering Cancer Center |
| NCT07126236 | Phase 2 | Aug 4, 2025 | AbbVie, Evidenze Health España (CRO), Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea, Hospital General Universitario Gregorio Marañon, Incyte, Universidad Autonoma de Barcelona |
| NCT06792825 | Phase 2 | Jul 1, 2025 | Incyte, University of Minnesota |
| NCT06760156 | Phase 2 | Dec 19, 2024 | Incyte, University of South Florida |
| NCT06434363 | Phase 1/Phase 2 (Phase 2) | Jul 31, 2024 | University of Texas at Houston |
| NCT06521255 | Phase 3 | May 7, 2024 | Beijing InnoCare Pharma Tech Co., Ltd. |
| NCT06029309 | Phase 1/Phase 2 (Phase 2) | Jan 31, 2024 | BeOne Medicines, Incyte, MorphoSys, University of Miami |
| NCT05993611 | Phase 1 | Jan 17, 2024 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT05910801 | Phase 2 | Dec 29, 2023 | Academic and Community Cancer Research United, National Cancer Institute (NCI) |
| NCT05943496 | Phase 1 | Oct 2, 2023 | Incyte, OHSU Knight Cancer Institute, Oregon Health and Science University |
| NCT05890352 | Phase 2 | Sep 26, 2023 | BeOne Medicines, Incyte, Ipsen, National Cancer Institute (NCI), SWOG Cancer Research Network |
| NCT05821088 | Phase 2 | Jun 29, 2023 | Ohio State University |
| NCT05718869 | Phase 2 | May 18, 2023 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT05615636 | Phase 2 | Apr 30, 2023 | University of Texas at Houston |
| NCT05786040 | Phase 2 | Mar 23, 2023 | Ohio State University |
| NCT05788289 | Phase 2 | Mar 14, 2023 | Incyte, Memorial Sloan-Kettering Cancer Center |
| NCT05583071 | Phase 2 | Jan 31, 2023 | Incyte, University of Cologne |
| NCT05455697 | Phase 1/Phase 2 (Phase 2) | Jan 7, 2023 | University of Washington |
Showing 20 of 47 trials
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Organizations
Research & Development (41)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Incyte | For profit | 19 | 6 | 3 | 2020 |
| MorphoSys | For profit | 12 | 9 | 4 | 2013 |
| Ohio State University | Academic/Hospital | 5 | 3 | 1 | 2013 |
| National Cancer Institute (NCI) | Government | 4 | 0 | 2 | 2023 |
| University of Texas at Houston | Academic/Hospital | 4 | 3 | 1 | 2013 |
| Beijing InnoCare Pharma Tech Co., Ltd. | For profit | 2 | 2 | 2 | 2021 |
| BeOne Medicines | For profit | 2 | 0 | 1 | 2023 |
| City of Hope National Medical Center | Academic/Hospital | 2 | 2 | 2 | 2023 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 2 | 2 | 1 | 2023 |
| University of Washington | Academic/Hospital | 2 | 2 | 1 | 2023 |
| AbbVie | For profit | 1 | 0 | 1 | 2025 |
| Academic and Community Cancer Research United | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Bristol-Myers Squibb | For profit | 1 | 0 | 1 | 2021 |
| Case Western Reserve University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Celgene | For profit | 1 | 1 | 1 | 2021 |
| Clinigene International Ltd | For profit | 1 | 0 | 1 | — |
| Epizyme, Inc. | For profit | 1 | 1 | 1 | 2021 |
| Evidenze Health España (CRO) | For profit | 1 | 0 | 1 | 2025 |
| Genmab | For profit | 1 | 0 | 1 | 2025 |
| Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea | Academic/Hospital | 1 | 1 | 1 | 2025 |
41 organizations
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