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DRUG:

Lynozyfic (linvoseltamab-gcpt)

i
Other names: REGN5458, REGN 5458, BCMAxCD3 antibody, BCMAxCD3 bispecific antibody
Associations
Trials
Company:
Regeneron
Drug class:
CD3 agonist, BCMA inhibitor
Related drugs:
Associations
Trials
8d
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: Mar 2026 --> Jul 2026
Trial initiation date
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Lynozyfic (linvoseltamab-gcpt)
13d
New P1 trial • First-in-human
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Lynozyfic (linvoseltamab-gcpt)
16d
Advances in multiple myeloma: key updates from the ASH 2025 meeting. (PubMed, J Hematol Oncol)
In newly diagnosed MM (NDMM), minimal residual disease (MRD)-adaptive consolidation with linvoseltamab in IMMUNOPLANT converted persistent MRD positivity to MRD negativity in all evaluable patients, supporting biologically guided treatment intensification...In early relapsed/refractory MM (RRMM), the pioneering phase III MajesTEC-3 trial demonstrated significant progression-free survival (PFS) and overall survival (OS) benefits with BsAb teclistamab plus daratumumab compared to other standard triplets, with response rates approaching those historically observed with chimeric antigen receptor (CAR) T cell therapy. A novel rational BsAb combination of BsAb elranatamab anda cereblon E3 ligase modulatory drug (CELMoD) iberdomide in MagnetisMM-30 showed promising synergy despite cytopenias and updates to combination BsAb targeting in RedirecTT-1 demonstrated major activity in difficult to treat extramedullary myeloma (EMM). First-in-human inMMyCAR data showcased the forefront of engineered immune strategies, by introducing an in vivo CAR-T product as a proof-of-concept platform, with tremendous potential to streamline the access to therapy. Collectively, these studies signal a shift toward earlier and adaptive immunotherapy in all phases of MM disease, while underscoring the importance of infection mitigation and long-term safety evaluation.
Journal • First-in-human
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CRBN (Cereblon)
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Darzalex (daratumumab) • Elrexfio (elranatamab-bcmm) • Tecvayli (teclistamab-cqyv) • iberdomide (CC-220) • Lynozyfic (linvoseltamab-gcpt)
16d
Trial initiation date
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bortezomib • carfilzomib • dexamethasone • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Lynozyfic (linvoseltamab-gcpt)
24d
Enrollment open • First-in-human
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Lynozyfic (linvoseltamab-gcpt)
2ms
Trial initiation date
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lenalidomide • Darzalex (daratumumab) • dexamethasone • Lynozyfic (linvoseltamab-gcpt)
2ms
New P1/2 trial • First-in-human
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Lynozyfic (linvoseltamab-gcpt)
2ms
Enrollment open
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Lynozyfic (linvoseltamab-gcpt)
3ms
New P2/3 trial
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lenalidomide • bortezomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Lynozyfic (linvoseltamab-gcpt)
3ms
Enrollment closed
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Lynozyfic (linvoseltamab-gcpt)
3ms
New P2/3 trial
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lenalidomide • Darzalex (daratumumab) • dexamethasone • Lynozyfic (linvoseltamab-gcpt)
3ms
New P2/3 trial
|
bortezomib • Darzalex (daratumumab) • carfilzomib • dexamethasone • pomalidomide • Lynozyfic (linvoseltamab-gcpt)