NCT03761108

Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 387 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to learn about the safety of linvoseltamab and to find out what is the best dose of linvoseltamab to give to patients with multiple myeloma and to look for any signs that linvoseltamab can effectively treat cancer. The study is looking at several other research questions, including: * Side effects that may be experienced by people receiving linvoseltamab * How linvoseltamab works in the body * How much linvoseltamab is present in the blood * How linvoseltamab may work to treat cancer

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Linvoseltamab	Administered per the protocol

Timeline

• Start date: 2019-01-23
• Primary completion: 2033-03-30
• Completion: 2033-06-16
• First posted: 2018-12-03
• Last updated: 2026-04-01

Locations

40 sites across 7 countries: United States, Belgium, Germany, Japan, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study