Therapy Detail
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| Therapy Name | Linvoseltamab |
| Synonyms | |
| Therapy Description |
Linvoseltamab (REGN5458) is a bispecific antibody that binds to TNFRSF17 (BCMA) and CD3 with potential antitumor activity (Blood (2019) 134 (Supplement_1): 3176). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Linvoseltamab | REGN5458|REGN-5458|REGN 5458|Anti-BCMA/CD3 BiTE | CD3 Antibody 99 TNFRSF17 Antibody 20 | Linvoseltamab (REGN5458) is a bispecific antibody that binds to TNFRSF17 (BCMA) and CD3 with potential antitumor activity (Blood (2019) 134 (Supplement_1): 3176). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05730036 | Phase III | Linvoseltamab Dexamethasone + Elotuzumab + Pomalidomide | A Study to Learn How Linvoseltamab (REGN5458) Will Work Compared to the Elotuzumab, Pomalidomide and Dexamethasone (EPd) Combination, in Participants With Relapsed/Refractory Multiple Myeloma (LINKER-MM3) | Recruiting | USA | POL | NLD | ITA | ISR | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | 4 |
| NCT06140524 | Phase II | Linvoseltamab | A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma (LINKER-MGUS1) | Recruiting | USA | ESP | 0 |
| NCT06376526 | Phase II | Linvoseltamab | IMMUNOPLANT for Newly Diagnosed Multiple Myeloma (IMMUNOPLANT) | Recruiting | USA | 0 |
| NCT03761108 | Phase Ib/II | Linvoseltamab | First in Human (FIH) Study of REGN5458 in Patients With Relapsed or Refractory Multiple Myeloma | Recruiting | USA | GBR | ESP | DEU | BEL | 2 |
| NCT05955508 | Phase II | Linvoseltamab | A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma | Recruiting | ESP | 0 |
| NCT05828511 | Phase Ib/II | Linvoseltamab | A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment. (LINKER-MM4) | Recruiting | USA | FRA | ESP | 0 |
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