A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody (NCT07258511)

JNJ-79635322 (BCMAxGPRC5DxCD3) is a novel immunoglobulin G1 trispecific antibody targeting the T-cell receptor (CD3 portion) with 1 binding arm and 2 plasma cell target antigen binding domains (BCMA and GPRC5D). The primary objective is to compare the efficacy of JNJ-79635322 with an anti-BCMAxCD3 bispecific antibody (Teclistamab), based on dual primary endpoints of ORR and PFS, in participants with RRMMwho have received at least 3 prior lines of therapy including a PI, an IMiD, and an anti-CD38 antibody.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Andrew Spencer

Key inclusion data

INCLUSION: Multiple Myeloma (MM) diagnosis according to the international myeloma working group (IMWG) diagnostic criteria; Measurable disease at screening as assessed by central laboratory; Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD)38 antibody. EXCLUSION: Active hepatitis of infectious origin; Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM.