REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Participants With Relapsed/Refractory Multiple Myeloma

• Status: Not yet recruiting
• Trial end date: 2030-03-16

Summary

The primary objective of the study is to assess the safety and tolerability, and identify the recommended dose of REGN5458 for the expansion portion in combination with each one of the following cancer treatments:

• Daratumumab plus dexamethasone (Dd: Cohort 1)

• Carfilzomib plus dexamethasone (Kd: Cohort 2)

• Lenalidomide plus dexamethasone (Rd: Cohort 3)

• Bortezomib plus dexamethasone Vd: (Cohort 4)

The secondary objectives of the study for each cohort are:

• To assess the preliminary anti-tumor activity by International Myeloma Working Group (IMWG) criteria

• To measure the depth and durability of response

• To evaluate the pharmacokinetic (PK) properties of REGN5458 when given in combination with Dd, Kd, Rd, and Vd

• To evaluate immunogenicity of REGN5458 when given in combination with Dd, Kd, Rd, and Vd

• Describe the overall survival (OS) of the participants

• Phase: Phase 1

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Treatments: Bortezomib; Daratumumab; Dexamethasone; Lenalidomide