LINKER-MM4

Phase 1/2 Study of Linvoseltamab (Anti-BCMA X Anti-CD3 Bispecific Antibody) in Previously Untreated Patients With Symptomatic Multiple Myeloma

What's the purpose of the trial?

The aim of this clinical trial is to study the safety, tolerability (how the body reacts to the drug), and effectiveness (tumor shrinkage) of linvoseltamab in study participants with NDMM as a first step in determining if the study drug has a role in the treatment of NDMM.

Trial status

Accepting patients

Phase
Phase 1/2
Enrollment
149
Last Updated

Participating Centers

There are 13 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Linvoseltamab is a bispecific antibody being tested for use in multiple myeloma that targets BCMA on cancer cells and CD3 on T-cells . 

Published Results

Explore published results and other resources associated with this clinical trial (including press releases, news articles and videos).

Linvoseltamab Generates Responses in Newly Diagnosed Myeloma

The LINKER-MM4 trial enrolled 45 adult patients with previously untreated, symptomatic multiple myeloma. The cohort included both transplant-eligible (62.2%) and transplant-ineligible patients. As of the September 15, 2025, data cutoff, the median follow-up was 11.2 months for the phase 1a dose-escalation cohort and 4.8 months for the phase 1b dose-expansion cohort.

Responses were rapid, with a median time to partial response or better of 1.2 months.

Among the 43 patients evaluable for response:

  • 56% achieved a very good partial response (VGPR) or better.
  • 26% achieved a complete response (CR) or better.
  • 82% of patients who achieved a CR did so within 6 months of treatment initiation.

The efficacy data indicated a dose-dependent response. Patients in the 200 mg cohort (n = 21) demonstrated higher response rates compared with the 50 mg cohort (n = 20), with 86% vs 70% ORR, respectively. At the time of analysis, all patients remained progression-free.

2025-12-08T00:00:00Z Read more

Real People. Real Support.

Need help connecting with this clinical trial? We're here to help!

Print a patient-friendly report to share with your patient.

We can help answer any questions and connect you (or your patient) with the study team.

Schedule a time that is convenient and we’ll call you to see how we can help you and your patient.