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DRUG:

Lynozyfic (linvoseltamab-gcpt)

i
Other names: REGN5458, REGN 5458, BCMAxCD3 antibody, BCMAxCD3 bispecific antibody
Associations
Trials
Company:
Regeneron, Sanofi
Drug class:
CD3 agonist, BCMA inhibitor
Related drugs:
Associations
Trials
4d
BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM) (clinicaltrials.gov)
P2, N=34, Not yet recruiting, Medical College of Wisconsin | Initiation date: Dec 2025 --> Mar 2026
Trial initiation date
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Lynozyfic (linvoseltamab-gcpt)
13d
Enrollment open
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bortezomib • carfilzomib • dexamethasone • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Lynozyfic (linvoseltamab-gcpt)
18d
BCMA biology and therapeutic targeting in multiple myeloma: From ligand signaling to antigen escape. (PubMed, Semin Hematol)
We then summarize the clinical development and distinguishing features of currently approved BCMA-targeted modalities-CAR T-cell therapies (ide-cel, cilta-cel), bispecific T-cell engagers (teclistamab, elranatamab, linvoseltamab), and the antibody-drug conjugate (belantamab mafodotin)-highlighting their efficacy, toxicity profiles, and practical positioning in relapsed/refractory MM. Finally, we review emerging resistance mechanisms, including γ-secretase-driven sBCMA elevation, ligand-rich APRIL/BAFF niches, and therapy-induced TNFRSF17 lesions, ranging from biallelic deletions to epitope-altering missense mutations and in-frame deletions within the BCMA extracellular domain. These insights inform rational strategies such as γ-secretase inhibition, dual-target CAR T-cells and bispecific T-cell engagers.
Journal • IO biomarker
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TNFRSF17 (TNF Receptor Superfamily Member 17)
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Elrexfio (elranatamab-bcmm) • Blenrep (belantamab mafodotin-blmf) • Abecma (idecabtagene vicleucel) • Carvykti (ciltacabtagene autoleucel) • Tecvayli (teclistamab-cqyv) • Lynozyfic (linvoseltamab-gcpt)
2ms
Enrollment open
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lenalidomide • Darzalex (daratumumab) • dexamethasone • Lynozyfic (linvoseltamab-gcpt)
3ms
New P3 trial
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bortezomib • carfilzomib • dexamethasone • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Lynozyfic (linvoseltamab-gcpt)
4ms
BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM) (clinicaltrials.gov)
P2, N=34, Not yet recruiting, Medical College of Wisconsin | Initiation date: Sep 2025 --> Dec 2025
Trial initiation date
|
Lynozyfic (linvoseltamab-gcpt)
5ms
New P1/2 trial
|
Lynozyfic (linvoseltamab-gcpt)
5ms
LINKER-MM1: Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
P1/2, N=387, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Jun 2032 --> Jun 2033 | Trial primary completion date: May 2032 --> Mar 2033
Trial completion date • Trial primary completion date
|
Lynozyfic (linvoseltamab-gcpt)
7ms
Horizon Two Adaptive Platform Study in High Risk Newly Diagnosed Multiple Myeloma (clinicaltrials.gov)
P2, N=300, Not yet recruiting, Multiple Myeloma Research Consortium
New P2 trial
|
clonoSEQ
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Sarclisa (isatuximab-irfc) • Lynozyfic (linvoseltamab-gcpt)
8ms
New P2 trial
|
Lynozyfic (linvoseltamab-gcpt)
8ms
Trial completion date • Trial primary completion date
|
lenalidomide • bortezomib • Libtayo (cemiplimab-rwlc) • carfilzomib • pomalidomide • Sarclisa (isatuximab-irfc) • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Ogsiveo (nirogacestat) • fianlimab (REGN3767) • Lynozyfic (linvoseltamab-gcpt) • cevostamab (RG6160)
9ms
Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy (clinicaltrials.gov)
P1, N=6, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Oct 2025 --> Mar 2028 | Trial primary completion date: Oct 2025 --> Mar 2028
Trial completion date • Trial primary completion date
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Dupixent (dupilumab) • Lynozyfic (linvoseltamab-gcpt)