LINKER-MM1

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

Official title

Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients With Relapsed or Refractory Multiple Myeloma

Phase

Phase 1/Phase 2

Status

Recruiting

Conditions

Multiple Myeloma

Interventions

Linvoseltamab

Arms

• Linvoseltamab - Phase 1 · Experimental
• Linvoseltamab - Phase 2 - Cohort 1 · Experimental
• Linvoseltamab - Phase 2 - Cohort 2 · Experimental
• Linvoseltamab - Phase 2 - Cohort 3 · Experimental

Enrollment

387 (estimated)

Primary outcomes

• Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
• Incidence and severity of treatment-emergent adverse events (TEAEs)
• Incidence and severity of adverse events of special interest (AESI)
• Assessment of the pharmacokinetics (PK) of linvoseltamab
• Concentrations of linvoseltamab in serum over time
• Objective response rate (ORR) as determined by an Independent Review Committee (IRC)
• Incidence and severity of cytokine release syndrome (CRS) with linvoseltamab
• ORR of IV linvoseltamab as assessed by investigator

Sponsor

Regeneron Pharmaceuticals

Start

Jan 23, 2019

Primary completion

Mar 30, 2033 (estimated)

Results posted

No

Registry record

NCT03761108 · updated Apr 20, 2026

• Hoffman JE, Bumma N, Richter J, Dhodapkar MV, Lee HC, Suvannasankha A, Zonder JA, Maly JJ, Shah MR, Baz R, Inocencio TJ, DeVeaux M, Ivanescu C, Rodriguez Lorenc K, Kroog GS, Knorr K, Chi L, Harnett J, Ma Q, Jagannath S. Health-related quality of life with linvoseltamab treatment for relapsed/refractory multiple myeloma in LINKER-MM1. Blood Neoplasia. 2026 Mar 27;3(3):100225. doi: 10.1016/j.bneo.2026.100225. eCollection 2026 Aug. PubMed 42564571
• Lowy JA, Rogers MF, Avigan ZM, Flores MS, Samuel M, Rattu MA, Richter J. Linvoseltamab, a BCMA-directed CD3 T-cell engager for multiple myeloma: a patient-centric option via a response-adapted dosing regimen. Expert Rev Hematol. 2026 Apr;19(4):361-372. doi: 10.1080/17474086.2026.2634283. Epub 2026 Mar 4. PubMed 41708325
• Lee HC, Zonder JA, Dhodapkar MV, Jagannath S, Hoffman JE, Suvannasankha A, Shah MR, Lentzsch S, Baz R, Maly JJ, Namburi S, Pianko MJ, Ye JC, Wu KL, Silbermann R, Min CK, Vekemans MC, Munder M, Byun JM, Martinez-Lopez J, DeVeaux M, Roccia T, Chokshi D, Seraphin M, Knorr K, Boyapati A, Hazra A, Rodriguez Lorenc K, Kroog GS, Bumma N, Richter J. Linvoseltamab in Patients With Relapsed/Refractory Multiple Myeloma in the LINKER-MM1 Study: Longer Follow-Up and Subgroup Analyses. Clin Lymphoma Myeloma Leuk. 2026 Feb;26(2):e201-e212.e8. doi: 10.1016/j.clml.2025.11.004. Epub 2025 Nov 12. PubMed 41387038
• Bumma N, Richter J, Jagannath S, Lee HC, Hoffman JE, Suvannasankha A, Zonder JA, Shah MR, Lentzsch S, Baz R, Maly JJ, Namburi S, Pianko MJ, Ye JC, Wu KL, Silbermann R, Min CK, Vekemans MC, Munder M, Byun JM, Martinez-Lopez J, Cassady K, DeVeaux M, Chokshi D, Boyapati A, Hazra A, Yancopoulos GD, Sirulnik LA, Rodriguez Lorenc K, Kroog GS, Houvras Y, Dhodapkar MV. Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma. J Clin Oncol. 2024 Aug 1;42(22):2702-2712. doi: 10.1200/JCO.24.01008. Epub 2024 Jun 16. PubMed 38879802