Recruiting
Phase 2

Linvoseltamab

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT06140524

Conditions

Monoclonal Gammopathy of Undetermined Significance (MGUS)

Smoldering Multiple Myeloma (SMM)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Linvoseltamab

Study Details

Brief summary:

This study is researching an investigational drug called linvoseltamab ("study drug") in participants at moderate risk of developing multiple myeloma (about 3 to 10% average annual risk), a group that consists of patients with precancerous conditions called High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM).

The primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of HR-MGUS and NHR-SMM.

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

  • How many participants treated with linvoseltamab have improvement of their HR-MGUS or NHR-SMM?
  • What side effects may happen from taking the study drug?
  • How much study drug is in the blood at different times?
  • Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects).

Conditions

Monoclonal Gammopathy of Undetermined Significance (MGUS)

Smoldering Multiple Myeloma (SMM)

Study ID

NCT06140524

Start date

Sep 16, 2024

Status verified date

Jul, 2026

Completion date

May 18, 2032

Anticipated

Primary completion date

May 18, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. HR-MGUS or NHR-SMM as defined in the protocol
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
3. Adequate hematologic and hepatic function, as described in the protocol
4. Estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) equation

Key Exclusion Criteria:

1. High-risk SMM, as defined in the protocol
2. Evidence of any of myeloma-defining events, as described in the protocol
3. Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), solitary plasmacytoma, or symptomatic MM
4. Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol
5. Any infection requiring hospitalization or treatment with intravenous (IV) anti-infectives within 28 days of the first dose of linvoseltamab
6. Uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection; or other uncontrolled infection or unexplained signs of infection, as described in the protocol

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Design

Enrollment

116 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Safety Run-In (Part 1)

Sequential groups of participants will be enrolled to assess the initial safety and tolerability of the step-up regimen leading up to the start of different full doses of linvoseltamab.

experimental: Expansion (Part 2) - Dose regimen 1

Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens

experimental: Expansion (Part 2) - Dose regimen 2

Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens

experimental: Expansion (Part 2) - Dose regimen 3

Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens

experimental: Expansion (Part 2) - Dose regimen 4

Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens

Interventions

Linvoseltamab

Administered per the protocol

Primary outcome measure

  • Frequency of Adverse Events Interest (AEI) during the safety observation period [ Time Frame: 35 days ]
  • Frequency of Treatment-Emergent Adverse Event (TEAEs) during the safety observation period [ Time Frame: 35 days ]
  • Severity of TEAEs during the safety observation period [ Time Frame: 35 days ]
  • Achievement of Complete Response (CR) as determined by the investigator [ Time Frame: Up to 5.5 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

University of Michigan Health

Recruiting

Ann Arbor, Michigan, United States, 48109

NYU Langone Health Perlmutter Cancer Center

Recruiting

New York, New York, United States, 10016

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

University of Washington

Recruiting

Seattle, Washington, United States, 98109

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • linvoseltamab
  • monoclonal immunoglobulin (M-protein)
  • cancer interception
  • immunotherapy
  • plasma cell disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-18. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-07-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.