Tafasitamab
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Also known as MinjuviMOR-00208Mor-208Mor00208MOR208MonjuviMonjuvi (tafasitamab-cxix) for injectionTafasitamab cxixTafasitamab-cxixXmab-5574Xmab5574
Summary
Tafasitamab (CHEMBL4298047) is an approved antibody (ATC L01FX12) targeting CD19; indicated across 13 conditions including diffuse large b-cell lymphoma and neoplasm.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Antibody
- ATC class: L01FX12
- Targets: 1 (CD19)
- Indications: 13 conditions
- Clinical trials: 50
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4298047 |
| Name | Tafasitamab |
| Type | Antibody |
| Max phase | 4 |
| ATC | L01FX12 |
Also known as: Minjuvi, MOR-00208, Mor-208, Mor00208, MOR00208, MOR208, Monjuvi, Monjuvi (tafasitamab-cxix) for injection, Tafasitamab, Tafasitamab cxix, Tafasitamab-cxix, Xmab-5574
Targets
Targets
Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| CD19 | CD19 | Binding | 2.5% | P15391 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 1 target gene(s): CD19.
Top Reactome pathways
17 total, by targets touching each:
| Pathway | Targets | Genes |
|---|---|---|
| PIP3 activates AKT signaling | 1 | CD19 |
| Adaptive Immune System | 1 | CD19 |
| Signal Transduction | 1 | CD19 |
| Disease | 1 | CD19 |
| Complement cascade | 1 | CD19 |
| Innate Immune System | 1 | CD19 |
| Immune System | 1 | CD19 |
| Immunoregulatory interactions between a Lymphoid and a non-Lymphoid cell | 1 | CD19 |
| Negative regulation of the PI3K/AKT network | 1 | CD19 |
| PI3K/AKT Signaling in Cancer | 1 | CD19 |
| Constitutive Signaling by Aberrant PI3K in Cancer | 1 | CD19 |
| Diseases of signal transduction by growth factor receptors and second messengers | 1 | CD19 |
| PI5P, PP2A and IER3 Regulate PI3K/AKT Signaling | 1 | CD19 |
| Intracellular signaling by second messengers | 1 | CD19 |
| Regulation of Complement cascade | 1 | CD19 |
| Antigen activates B Cell Receptor (BCR) leading to generation of second messengers | 1 | CD19 |
| Signaling by the B Cell Receptor (BCR) | 1 | CD19 |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| B-1 B cell differentiation | 1 |
| B cell proliferation involved in immune response | 1 |
| immunoglobulin mediated immune response | 1 |
| B cell proliferation | 1 |
| antigen receptor-mediated signaling pathway | 1 |
| B cell receptor signaling pathway | 1 |
| regulation of B cell receptor signaling pathway | 1 |
| regulation of B cell activation | 1 |
| positive regulation of release of sequestered calcium ion into cytosol | 1 |
| positive regulation of phosphatidylinositol 3-kinase/protein kinase B signal transduction | 1 |
| adaptive immune response | 1 |
| immune system process | 1 |
| B cell mediated immunity | 1 |
Indications & clinical
Indications
13 indications (4 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| diffuse large B-cell lymphoma | 4 | MONDO:0018905 | EFO:0000403 |
| neoplasm | 4 | MONDO:0005070 | EFO:0000616 |
| lymphoma | 4 | MONDO:0005062 | EFO:0000574 |
| neoplasm of mature B-cells | 3 | MONDO:0004949 | EFO:0000096 |
| follicular lymphoma | 3 | MONDO:0018906 | MONDO:0018906 |
| B-cell chronic lymphocytic leukemia | 2 | MONDO:0004948 | EFO:0000095 |
| acute lymphoblastic leukemia | 2 | MONDO:0004967 | EFO:0000220 |
| non-Hodgkin lymphoma | 2 | MONDO:0018908 | EFO:0005952 |
| prolymphocytic leukemia | 2 | MONDO:0001023 | MONDO:0001023 |
| mantle cell lymphoma | 2 | MONDO:0018876 | EFO:1001469 |
| marginal zone lymphoma | 2 | MONDO:0017604 | EFO:1000630 |
| hematopoietic and lymphoid system neoplasm | 1 | MONDO:0002334 | MONDO:0002334 |
1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 50.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 24 |
| PHASE1/PHASE2 | 13 |
| PHASE1 | 5 |
| PHASE3 | 4 |
| Not specified | 2 |
| PHASE2/PHASE3 | 1 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT04680052 | PHASE3 | ACTIVE_NOT_RECRUITING | A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. |
| NCT04824092 | PHASE3 | ACTIVE_NOT_RECRUITING | Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients |
| NCT05429268 | PHASE3 | ACTIVE_NOT_RECRUITING | Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND) |
| NCT06521255 | PHASE3 | RECRUITING | Evaluate the Safety and Efficacy of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma |
| NCT02763319 | PHASE2/PHASE3 | COMPLETED | A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) |
| NCT03930953 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL) |
| NCT04646395 | PHASE2 | ACTIVE_NOT_RECRUITING | Study of Acalabrutinib and Tafasitamab in MZL Patients |
| NCT04661007 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL) |
| NCT04974216 | PHASE2 | ACTIVE_NOT_RECRUITING | Study of Tafasitamab and Lenalinomide Associated to Rituximab in Frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or Older |
| NCT04978584 | PHASE2 | ACTIVE_NOT_RECRUITING | Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Alone and With Combination Chemotherapy for the Treatment of Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma, Smart Stop Study |
| NCT05222555 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients |
| NCT05351593 | PHASE1/PHASE2 | RECRUITING | Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma |
| NCT05366218 | PHASE1/PHASE2 | RECRUITING | Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia |
| NCT05453500 | PHASE2 | ACTIVE_NOT_RECRUITING | Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia |
| NCT05455697 | PHASE1/PHASE2 | RECRUITING | Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma |
| NCT05552937 | PHASE2 | RECRUITING | Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory DLBCL |
| NCT05583071 | PHASE2 | RECRUITING | Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL |
| NCT05615636 | PHASE2 | RECRUITING | A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL |
| NCT05718869 | PHASE2 | ACTIVE_NOT_RECRUITING | Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study |
| NCT05786040 | PHASE2 | RECRUITING | Tafasitamab and Rituximab for Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder |
| NCT05821088 | PHASE2 | RECRUITING | Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE as Salvage Therapy for Transplant Eligible Patients With Relapsed/ Refractory Large B-Cell Lymphoma |
| NCT05890352 | PHASE2 | RECRUITING | Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment |
| NCT05910801 | PHASE2 | RECRUITING | Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma |
| NCT06029309 | PHASE1/PHASE2 | RECRUITING | Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma |
| NCT06434363 | PHASE1/PHASE2 | RECRUITING | Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders |
| NCT06465433 | PHASE2 | RECRUITING | Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab |
| NCT06760156 | PHASE2 | RECRUITING | Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym |
| NCT06792825 | PHASE2 | RECRUITING | HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL |
| NCT07502872 | PHASE2 | NOT_YET_RECRUITING | TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma |
| NCT07582159 | PHASE2 | NOT_YET_RECRUITING | Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
| NCT07585747 | PHASE2 | NOT_YET_RECRUITING | A Exploratory Study on Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide |
| NCT02005289 | PHASE2 | COMPLETED | Phase II MOR00208 in Combination With Lenalidomide for Patients With Relapsed or Refractory CLL, SLL or PLL or Older Patients With Untreated CLL, SLL or PLL |
| NCT02399085 | PHASE2 | COMPLETED | Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL |
| NCT02639910 | PHASE2 | COMPLETED | Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi |
| NCT04607772 | PHASE1/PHASE2 | WITHDRAWN | Study of Selinexor in Combination With Backbone Treatments or Novel Therapies In Participants With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL) |
| NCT04809467 | PHASE1/PHASE2 | TERMINATED | A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL) |
| NCT04882163 | PHASE1/PHASE2 | WITHDRAWN | Study to Evaluate Tolerability of Iberdomide (CC-220) in Combination With Polatuzumab Vedotin Plus Rituximab or Tafasitamab or Rituximab Plus Chemotherapy in B-cell Lymphoma |
| NCT05205252 | PHASE1/PHASE2 | WITHDRAWN | A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer. |
| NCT05328102 | PHASE2 | TERMINATED | Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Relapsed or Refractory (R/R) Diffuse Large-cell B-cell Lymphoma (DLBCL) |
| NCT05626322 | PHASE1/PHASE2 | TERMINATED | Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Genes: CD19
- Diseases: diffuse large B-cell lymphoma, neoplasm, lymphoma, neoplasm of mature B-cells, follicular lymphoma