Recruiting
Phase 4

Tocilizumab & Linvoseltamab

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07609940

Conditions

Relapsed/Refractory Multiple Myeloma (RRMM)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Linvoseltamab

Tocilizumab

Study Details

Brief summary:

This study is researching whether the use of tocilizumab before the first dose of linvoseltamab will decrease the risk of Cytokine Release Syndrome (CRS) in participants who have Relapsed or Refractory Multiple Myeloma (RRMM) who have already been treated with at least four lines of treatment for their multiple myeloma, including medicines called a proteasome inhibitor, an immunomodulatory drug, and an anti-Cluster of Differentiation (CD) 38 antibody.

The aim of the study is to see how safe, tolerable and effective linvoseltamab is when given after tocilizumab.

The study is looking at several other research questions, including:

  • What side effects may happen from taking tocilizumab before the first dose of linvoseltamab
  • Whether tocilizumab has an impact on CRS, including whether participants require hospital care and, if so, how many hospital visits occur and how long they last
  • How frequently other medications (for example, corticosteroids or additional doses of tocilizumab) are used to support participants' care if needed

Conditions

Relapsed/Refractory Multiple Myeloma (RRMM)

Study ID

NCT07609940

Start date

Jul 15, 2026

Status verified date

Sep, 2026

Completion date

Dec 6, 2028

Anticipated

Primary completion date

Oct 11, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Disease progression on or after at least 4 prior lines of therapy including a(n) Protease Inhibitor (PI), Immunomodulatory imide Drug (IMiD), and anti-CD 38 antibody
2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy

Key Exclusion Criteria:

1. Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome
2. Known myeloma brain lesions or meningeal involvement
3. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy \[PML\], or Central Nervous System (CNS) movement disorder

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Linvoseltamab

Interventions

Linvoseltamab

Administered per the protocol

Tocilizumab

Administered per the protocol

Primary outcome measure

  • Occurrence of any grade CRS per American Society for Transplantation and Cellular Therapy (ASTCT) grading [ Time Frame: Up to 28 days ]
  • Severity of any grade CRS per ASTCT grading [ Time Frame: Up to 28 days ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Berenson Cancer Center

Recruiting

Los Angeles, California, United States, 90069

Comprehensive Hematology Oncology

Recruiting

St. Petersburg, Florida, United States, 33709

Mary Bird Perkins Cancer Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

American Oncology Partners, PA dba The Center for Cancer and Blood Disorders

Recruiting

Bethesda, Maryland, United States, 20817

Northwest Medical Specialties, PLLC

Recruiting

Tacoma, Washington, United States, 98405

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • Cytokine Release Syndrome (CRS)
  • Linvoseltamab
  • Tocilizumab
  • Bispecific antibodies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.