Mosunetuzumab
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Also known as BTCT-4465ABTCT4465ALunsumioMosunetuzumab axgbMosunetuzumab-axgbRG-7828RG-7828 (ANTI-CD20 & CD3)RG7828RO-7030816RO7030816
Summary
Mosunetuzumab (CHEMBL4297788) is an approved antibody (ATC L01FX25) targeting MS4A1 and CD3E; indicated across 11 conditions including neoplasm of mature b-cells and follicular lymphoma.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Antibody
- ATC class: L01FX25
- Targets: 2 (MS4A1, CD3E)
- Indications: 11 conditions
- Clinical trials: 48
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4297788 |
| Name | Mosunetuzumab |
| Type | Antibody |
| Max phase | 4 |
| ATC | L01FX25 |
Also known as: BTCT-4465A, BTCT4465A, Lunsumio, Mosunetuzumab, Mosunetuzumab axgb, Mosunetuzumab-axgb, RG-7828, RG-7828 (ANTI-CD20 & CD3), RG7828, RO-7030816, RO7030816, MOSUNETUZUMAB
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 |
|---|---|---|---|---|---|
| MS4A1 | CD20 (membrane-spanning 4-domains, subfamily A, member 1) | Binding | 0% | P11836 | |
| CD3E | CD3e | Agonist | 0% | P07766 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 2 target gene(s): MS4A1, CD3E.
Top Reactome pathways
10 total, by targets touching each:
| Pathway | Targets | Genes |
|---|---|---|
| Adaptive Immune System | 1 | CD3E |
| Immune System | 1 | CD3E |
| Immunoregulatory interactions between a Lymphoid and a non-Lymphoid cell | 1 | CD3E |
| TCR signaling | 1 | CD3E |
| Downstream TCR signaling | 1 | CD3E |
| Phosphorylation of CD3 and TCR zeta chains | 1 | CD3E |
| Translocation of ZAP-70 to Immunological synapse | 1 | CD3E |
| Generation of second messenger molecules | 1 | CD3E |
| Regulation of T cell activation by CD28 family | 1 | CD3E |
| Co-inhibition by PD-1 | 1 | CD3E |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| cell surface receptor signaling pathway | 2 |
| store-operated calcium entry | 1 |
| humoral immune response | 1 |
| response to bacterium | 1 |
| B cell differentiation | 1 |
| B cell proliferation | 1 |
| B cell activation | 1 |
| B cell receptor signaling pathway | 1 |
| protein tetramerization | 1 |
| calcium ion import into cytosol | 1 |
| positive regulation of calcium ion import across plasma membrane | 1 |
| positive regulation of cell-matrix adhesion | 1 |
| adaptive immune response | 1 |
| positive regulation of T cell anergy | 1 |
| T cell anergy | 1 |
Indications & clinical
Indications
11 indications (3 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 |
|---|---|---|---|
| neoplasm of mature B-cells | 4 | MONDO:0004949 | EFO:0000096 |
| follicular lymphoma | 4 | MONDO:0018906 | MONDO:0018906 |
| neoplasm | 4 | MONDO:0005070 | EFO:0000616 |
| non-Hodgkin lymphoma | 3 | MONDO:0018908 | EFO:0005952 |
| diffuse large B-cell lymphoma | 2 | MONDO:0018905 | EFO:0000403 |
| MALT lymphoma | 2 | MONDO:0007650 | EFO:0000191 |
| marginal zone lymphoma | 2 | MONDO:0017604 | EFO:1000630 |
| B-cell chronic lymphocytic leukemia | 1 | MONDO:0004948 | EFO:0000095 |
| hematopoietic and lymphoid system neoplasm | 1 | MONDO:0002334 | MONDO:0002334 |
| B-cell acute lymphoblastic leukemia | 1 | MONDO:0004947 | EFO:0000094 |
| B-cell non-Hodgkin lymphoma | 1 | MONDO:0015759 | EFO:1001938 |
Clinical trials
Total trials: 48.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 25 |
| PHASE1/PHASE2 | 9 |
| PHASE1 | 8 |
| PHASE3 | 5 |
| Not specified | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT04712097 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma |
| NCT05171647 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin’s Lymphoma |
| NCT06006117 | PHASE3 | RECRUITING | Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma |
| NCT06284122 | PHASE3 | RECRUITING | Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5 |
| NCT06337318 | PHASE3 | RECRUITING | Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma |
| NCT03671018 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma |
| NCT04246086 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma |
| NCT04792502 | PHASE2 | RECRUITING | Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma |
| NCT04889716 | PHASE2 | RECRUITING | CAR-T Followed by Bispecific Antibodies |
| NCT05260957 | PHASE2 | RECRUITING | CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin’s Lymphoma (NHL). |
| NCT05389293 | PHASE2 | RECRUITING | A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma |
| NCT05410418 | PHASE2 | ACTIVE_NOT_RECRUITING | Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma |
| NCT05615636 | PHASE2 | RECRUITING | A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL |
| NCT05633615 | PHASE2 | RECRUITING | Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma |
| NCT05672251 | PHASE2 | RECRUITING | Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
| NCT05849857 | PHASE2 | RECRUITING | Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries |
| NCT05886036 | PHASE2 | RECRUITING | Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial |
| NCT05994235 | PHASE2 | ACTIVE_NOT_RECRUITING | Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma |
| NCT06090539 | PHASE1/PHASE2 | RECRUITING | A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas |
| NCT06249191 | PHASE1/PHASE2 | RECRUITING | Mosunetuzumab With Chemotherapy for the Treatment of Patients With Untreated C-Myc Rearrangement Positive High Grade B Cell Lymphoma or Diffuse Large B Cell Lymphoma |
| NCT06442475 | PHASE2 | RECRUITING | Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma |
| NCT06453044 | PHASE2 | RECRUITING | Mosunetuzumab and Polatuzumab Vedotin for the Treatment of Patients With Relapsed or Refractory Grade 1-3a Follicular Lymphoma |
| NCT06563505 | PHASE2 | RECRUITING | A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma |
| NCT06569680 | PHASE2 | RECRUITING | Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma |
| NCT06594939 | PHASE2 | NOT_YET_RECRUITING | Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma |
| NCT06634589 | PHASE1/PHASE2 | RECRUITING | A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies |
| NCT06828991 | PHASE2 | RECRUITING | A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHP |
| NCT06926205 | PHASE2 | RECRUITING | CHOP Plus Mosunetuzumab as First Line in Patients With Richter´s Syndrome: a Phase II Study of the Spanish Group of CLL |
| NCT06948786 | PHASE2 | RECRUITING | Pirtobrutinib and Mosunetuzumab for the Treatment of Relapsed/Refractory Grades 1-3A Follicular Lymphoma, PROMOTE-FL Trial |
| NCT07031700 | PHASE2 | NOT_YET_RECRUITING | A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for r/r FL |
| NCT07052695 | PHASE1/PHASE2 | RECRUITING | Mosunetuzumab for CLL MRD Clearance |
| NCT07548450 | PHASE2 | NOT_YET_RECRUITING | Mosunetuzumab in Combination With Pirtobrutinib in Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia (MPOWER) |
| NCT07555470 | PHASE2 | NOT_YET_RECRUITING | Mosunetuzumab and Zeprumetostat in Treating Patients With Follicular Lymphoma |
| NCT07566364 | PHASE2 | NOT_YET_RECRUITING | Phase 2 Study Of Mosunetuzumab In Patients With Chronic Lymphocytic Leukemia With Positive MRD |
| NCT07598396 | PHASE2 | RECRUITING | A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis |
| NCT03677141 | PHASE1/PHASE2 | COMPLETED | A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma |
| NCT03677154 | PHASE1/PHASE2 | COMPLETED | Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Participants With Previously Untreated Diffuse Large B-Cell Lymphoma |
| NCT05169658 | PHASE2 | COMPLETED | Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma |
| NCT05205252 | PHASE1/PHASE2 | WITHDRAWN | A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer. |
| NCT04970901 | PHASE1 | RECRUITING | A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7) |
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: MS4A1, CD3E
- Diseases: neoplasm of mature B-cells, follicular lymphoma, neoplasm, non-Hodgkin lymphoma