Recruiting
Phase 1
Phase 2

Linvoseltamab

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT05828511

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Linvoseltamab

Study Details

Brief summary:

This study is researching an experimental drug called linvoseltamab (called "study drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are eligible for high dose chemotherapy with autologous stem cell transplantation (transplant-eligible) or ineligible for autologous stem cell transplantation (transplant-ineligible).

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.

This study consists of 2 phases:

  • In Phase 1 Parts A and B, the study drug will be given to participants to study the side effects of the study drug and to establish the regimen (initial doses and full dose) of the study drug to be given to participants in Phase 2.
  • In Phase 1 Part C, the study drug will be given to participants to study the side effects when using different initial doses of the study drug.
  • In Phase 2, the study drug will be given to more participants to continue to assess the side effects of the study drug and to evaluate the activity of the study drug to shrink the tumor (multiple myeloma) in participants with NDMM.

The study is looking at several research questions, including:

  • What side effects may happen from taking linvoseltamab?
  • What the right dosing regimen is for linvoseltamab?
  • How many participants treated with linvoseltamab have improvement of their disease and for how long?
  • The effects of linvoseltamab study treatment before and after transplant
  • How much linvoseltamab is in the blood at different times?
  • Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects).

Conditions

Multiple Myeloma

Study ID

NCT05828511

Start date

Dec 19, 2023

Status verified date

May, 2026

Completion date

Nov 2, 2035

Anticipated

Primary completion date

Nov 2, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
2. Confirmed diagnosis of symptomatic Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnosis criteria, as described in the protocol
3. Response-evaluable myeloma, according to the 2016 IMWG response criteria, as defined in the protocol
4. No prior therapy for MM, with the exception of prior emergent or palliative radiation and up to 1 month of single-agent corticosteroids, with washout periods as per the protocol
5. Participants must have evidence of adequate bone marrow reserves and hepatic, renal and cardiac function as defined in the protocol
6. Participants must be age <70 and have adequate hepatic, renal, pulmonary and cardiac function to be considered transplant-eligible. The specific thresholds for adequate organ function are as per institutional guidance.

Key Exclusion Criteria:

1. Receiving any concurrent investigational agent with known or suspected activity against MM, or agents targeting the A proliferation-inducing ligand (APRIL)/ Transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI)/BCMA axis
2. Known Central Nervous System (CNS) involvement with MM, known or suspected Progressive Multifocal Leukoencephalopathy (PML), a history of neurocognitive conditions, or CNS movement disorder, or history of seizure within 12 months prior to study enrollment
3. Rapidly progressive symptomatic disease, (e.g. progressing renal failure or hypercalcemia not responsive to standard medical interventions), in urgent need of treatment with chemotherapy
4. Diagnosis of non-secretory MM, active plasma cell leukemia primary light-chain (AL) amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known POEMS syndrome (Plasma cell dyscrasia with polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes)

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study Design

Enrollment

149 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1 cohorts

Linvoseltamab dose escalation (part A), dose expansion (part B), and evaluation of alternative step-up regimen (part C) for participants with NDMM who are treatment-naïve.

experimental: Phase 2 - transplant ineligible cohort

Transplant-ineligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen until disease progression as per protocol.

experimental: Phase 2 - transplant eligible cohort

Transplant-eligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen for a fixed duration of treatment as per protocol

Interventions

Linvoseltamab

Linvoseltamab will be administered by intravenous (IV) infusion

Primary outcome measure

  • Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: End of the Observation period; up to day 28 ]
  • Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Post-Last Linvoseltamab Dose, up to 90 days ]
  • Severity of TEAEs [ Time Frame: Post-Last Linvoseltamab Dose, up to 90 days ]
  • Incidence of Adverse Events of Special Interest (AESIs) [ Time Frame: Post-Last Linvoseltamab Dose, up to 90 days ]
  • Severity of AESIs [ Time Frame: Post-Last Linvoseltamab Dose, up to 90 days ]
  • Proportion of participants with a Very Good Partial Response (VGPR) or better using the International Myeloma Working Group (IMWG) response criteria [ Time Frame: Up to 5 years ]
  • Proportion of participants achieving Minimal Residual Disease (MRD) negative status (at 10^-5) after induction with consolidation therapy [ Time Frame: Up to 5 years ]
  • Proportion of participants achieving MRD-negative status (at 10^-5) after induction without consolidation therapy [ Time Frame: Up to 5 years ]
  • Proportion of participants achieving MRD-negative status as their best response after treatment period I with continuing to treatment period II [ Time Frame: Up to 5 years ]
  • Proportion of participants achieving MRD-negative status as their best response after treatment period I without continuing to treatment period II [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

University of California Los Angeles (UCLA)

Recruiting

Los Angeles, California, United States, 90095

UC Irvine Health

Recruiting

Orange, California, United States, 92868

Colorado Blood Cancer Institute/SCRI

Recruiting

Denver, Colorado, United States, 80218

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40207

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Perlmutter Cancer Center

Recruiting

New York, New York, United States, 10016

Columbia University _ New York Presbyterian

Recruiting

New York, New York, United States, 10032

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Duke University Health System (DUHS)

Recruiting

Durham, North Carolina, United States, 27705

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

May 13, 2026

Last verified

May, 2026

Keywords

  • Newly Diagnosed Multiple Myeloma (NDMM)
  • Autologous Stem Cell Transplantation (ASCT)
  • Cluster of Differentiation 3 (CD3)
  • BCMA
  • High Dose chemoTherapy (HDT)
  • International Myeloma Working Group (IMWG)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-05-13.