Linvoseltamab
drug drugOn this page
Also known as REGN-5458REGN5458
Summary
Linvoseltamab (CHEMBL5095373) is a phase-3 clinical-stage antibody targeting TNFRSF17 and CD3E; indicated across 6 conditions including plasma cell myeloma and neoplasm.
At a glance
- Status: Max clinical phase 3 (not approved)
- Modality: Antibody
- Targets: 2 (TNFRSF17, CD3E)
- Indications: 6 conditions
- Clinical trials: 20
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL5095373 |
| Name | Linvoseltamab |
| Type | Antibody |
| Max phase | 3 |
Also known as: Linvoseltamab, REGN-5458, REGN5458, LINVOSELTAMAB
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 |
|---|---|---|---|---|---|
| TNFRSF17 | B cell maturation antigen | Binding | 7.64 | 0.1% | Q02223 |
| CD3E | CD3e | Binding | 6.92 | 0% | P07766 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 2 target gene(s): TNFRSF17, CD3E.
Top Reactome pathways
11 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 |
| TNFs bind their physiological receptors | 1 | TNFRSF17 |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| adaptive immune response | 2 |
| immune system process | 2 |
| lymphocyte homeostasis | 1 |
| signal transduction | 1 |
| tumor necrosis factor-mediated signaling pathway | 1 |
| positive regulation of cell-matrix adhesion | 1 |
| positive regulation of T cell anergy | 1 |
| T cell anergy | 1 |
| cell surface receptor signaling pathway | 1 |
| cell surface receptor protein tyrosine kinase signaling pathway | 1 |
| signal complex assembly | 1 |
| G protein-coupled receptor signaling pathway | 1 |
| smoothened signaling pathway | 1 |
| positive regulation of gene expression | 1 |
| negative regulation of gene expression | 1 |
Indications & clinical
Indications
6 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.
| Disease (in trials) | Phase | MONDO | EFO |
|---|---|---|---|
| plasma cell myeloma | 3 | MONDO:0009693 | EFO:0001378 |
| neoplasm | 2 | MONDO:0005070 | EFO:0000616 |
| chronic kidney disease | 1 | MONDO:0005300 | EFO:0003884 |
| plasma cell neoplasm | 1 | MONDO:0004959 | EFO:0000200 |
| food allergy | 1 | MONDO:0700226 | EFO:1001890 |
| hereditary amyloidosis | 1 | MONDO:0018634 | MONDO:0019438 |
Clinical trials
Total trials: 20.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE1/PHASE2 | 6 |
| PHASE2 | 5 |
| PHASE3 | 4 |
| PHASE1 | 2 |
| PHASE4 | 1 |
| PHASE2/PHASE3 | 1 |
| Not specified | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT07609940 | PHASE4 | NOT_YET_RECRUITING | Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS) |
| NCT05730036 | PHASE3 | RECRUITING | A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma |
| NCT06932562 | PHASE3 | RECRUITING | A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant |
| NCT07222761 | PHASE3 | RECRUITING | A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM) |
| NCT07393282 | PHASE3 | NOT_YET_RECRUITING | A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM) |
| NCT07428369 | PHASE2/PHASE3 | NOT_YET_RECRUITING | A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) |
| NCT03761108 | PHASE1/PHASE2 | RECRUITING | Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma |
| NCT05828511 | PHASE1/PHASE2 | RECRUITING | A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment |
| NCT05955508 | PHASE2 | ACTIVE_NOT_RECRUITING | A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Adult Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma |
| NCT06140524 | PHASE2 | RECRUITING | 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 |
| NCT06292780 | PHASE1/PHASE2 | RECRUITING | A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis) |
| NCT06376526 | PHASE2 | RECRUITING | IMMUNOPLANT for Newly Diagnosed Multiple Myeloma |
| NCT06669247 | PHASE1/PHASE2 | RECRUITING | A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma |
| NCT06910124 | PHASE2 | RECRUITING | Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse |
| NCT07009899 | PHASE2 | NOT_YET_RECRUITING | BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM) |
| NCT07181941 | PHASE1/PHASE2 | RECRUITING | Response-Based Dose Reduction of Linvoseltamab in the Treatment of Relapsed, Refractory, or Triple-Class Relapsed/Refractory Multiple Myeloma |
| NCT07455851 | PHASE1/PHASE2 | RECRUITING | A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma |
| NCT05137054 | PHASE1 | RECRUITING | A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments |
| NCT06369467 | PHASE1 | RECRUITING | Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy |
| NCT05164250 | Not specified | APPROVED_FOR_MARKETING | Compassionate Use (CU) of REGN5458 for Patients With Relapsed or Refractory Multiple Myeloma (MM) |
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: TNFRSF17, CD3E
- In clinical trials for: plasma cell myeloma, neoplasm