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New combo therapy aims to tackle Tough-to-Treat myeloma

NCT ID NCT05137054

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study tests an experimental drug called linvoseltamab combined with other cancer treatments for people with multiple myeloma that has come back after previous therapy. The main goal is to see if the combinations are safe and to find the right dose. About 317 participants will be enrolled, and researchers will also check if the tumors shrink or disappear.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
linvoseltamab (also called REGN5458) plus other cancer drugs (daratumumab, carfilzomib, lenalidomide, bortezomib)
What this could lead to
If successful, this could lead to a new combination treatment option for patients with multiple myeloma that has returned after prior therapies.
What could go wrong
This is an early Phase 1b study focused on safety and dosing, so it is too soon to know if the combinations will work. Side effects from the drugs are possible, and the trial is small.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 317 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Mar 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

General Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 2. Participants must have measurable disease as defined in the protocol according to IMWG consensus criteria 3. Adequate creatinine clearance, hematologic function and hepatic function, as defined in protocol 4. Life expectancy of at least 6 months Cohort Specific Inclusion Criteria: For cohorts 1-6, each participant must have RRMM with progression following at least 3 lines of therapy, or at least 2 lines of therapy and either prior exposure to at least 1 anti-CD38 antibody, 1 immunomodulatory imide drug (IMiD) and 1 Proteasome Inhibitor (PI), or double-refractory to 1 PI and 1 IMiD, or the combination of 1 PI and 1 IMiD Cohort 1: Prior treatment with daratumumab is allowed if previously tolerated, as described in the protocol Cohort 2: Prior treatment with carfilzomib is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 3: Prior treatment with lenalidomide is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 4: Prior treatment with bortezomib is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 5: Prior treatment with pomalidomide is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 6: Prior treatment with isatuximab is allowed if previously tolerated, as described in the protocol Cohort 7 and 8: 1. For participants without measurable disease by biochemical parameters \[serum or urine M-protein, or serum involved Free Light Chain (FLC)\], presence of at least 1 soft tissue plasmacytoma with a single diameter of ≥2 cm 2. RRMM with progressive disease and received at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1 IMiD, and 1 PI or triple-class refractory disease (anti-CD38 antibody, IMiD, PI) Cohort 9: Progressive RRMM in participants with triple-class refractory disease (anti-CD38 antibody, IMiD, PI) after at least 3 lines of therapy Cohort 10: Progressive RRMM after at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1 IMiD, and 1 PI General Key Exclusion Criteria: 1. Diagnosis of plasma cell leukemia, primary light-chain amyloidosis (excluding myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes) 2. Participants with known MM brain lesions or meningeal involvement 3. Treatment with any systemic anti-myeloma therapy within 5 half-lives or within 21 days prior to first administration of study drug regimen, whichever is shorter 4. History of allogeneic and autologous stem cell transplantation, as described in the protocol 5. Unless stated otherwise in a specific sub-protocol, prior treatment with a T cell-based immunotherapy directed against B-Cell Maturation Antigen (BCMA) bispecific antibodies and Bispecific T-cell Engagers (BiTEs), and BCMA Chimeric Antigen Receptor (CAR) T cells (Note: BCMA antibody-drug conjugates are not excluded) 6. History of progressive multifocal leukoencephalopathy, neurodegenerative condition or Central Nervous System (CNS) movement disorder or participants with a history of seizure within 12 months prior to study enrollment are excluded 7. Live or attenuated vaccination within 28 days prior to first study drug regimen administration with a vector that has replicative potential 8. Cardiac ejection fraction \<40% by Echocardiogram (Echo) or Multigated Acquisition (MUGA) scan Cohort Specific Exclusion Criteria: Cohort 2: Dose expansion: Prior treatment with a BCMA-directed CAR T-cell therapy will not be exclusionary if completed at least 12 weeks prior to first study treatment Cohort 3: Known malabsorption syndrome or pre-existing gastrointestinal (GI) condition that may impair absorption of lenalidomide; delivery of lenalidomide via nasogastric tube or gastrostomy tube is not allowed Cohort 4: Peripheral neuropathy grade ≥2 Cohort 5: Known malabsorption syndrome or pre-existing GI conditions that may impair absorption of pomalidomide; delivery of pomalidomide via nasogastric tube or gastrostomy tube is not allowed Cohort 7: 1. Prior treatment with anti-Lymphocyte Activation Gene 3 (LAG-3) agents. Prior exposure to vaccine therapies or other immune checkpoint modulating therapies such as anti-Programmed cell Death Protein 1 (PD-1) antibodies is permitted, as described in the protocol 2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that has required systemic treatment with immunosuppressive agents, as described in the protocol 3. Prior solid organ transplant 4. History of grade ≥3 immune-mediated adverse events (with the exclusion of endocrinopathies that are fully controlled by hormone replacement) from prior checkpoint inhibitor therapies Cohort 8: 1. Prior treatment with anti-PD-1 or anti-PD-L1 agents. Prior exposure to vaccine therapies or other immune checkpoint modulating therapies such as anti-Cytotoxic T Lymphocyte-Associated Antigen 4 (CTLA-4) antibodies is permitted, as described in the protocol 2. Encephalitis or meningitis in the year prior to enrollment 3. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to enrollment 4. Ongoing or recent (within 2 years) evidence of an autoimmune disease that has required systemic treatment with immunosuppressive agents, as described in the protocol. 5. Prior solid organ transplant 6. History of grade ≥3 immune-mediated adverse events (with the exclusion of endocrinopathies that are fully controlled by hormone replacement) from prior checkpoint inhibitor therapies Cohort 9: 1. Abnormal QT interval corrected by Fridericia's formula (QTcF), as described in the protocol 2. Use of concomitant medications that are known to prolong the QT/QTcF interval including Class Ia and Class III antiarrhythmics at the time of informed consent 3. Ongoing use or anticipated use of food or drugs that are known strong/moderate cytochrome P450 (CYP)3A4 inhibitors, or strong CYP3A inducers within 14 days prior to first dose of nirogacestat 4. Known malabsorption syndrome or existing gastrointestinal GI condition that may impair absorption of nirogacestat; delivery of nirogacestat via nasogastric tube or gastrostomy tube is not allowed Cohort 10: 1. Known or suspected active Epstein-Barr Virus (EBV) infection 2. Known history of Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) 3. Prior treatment with cevostamab or another agent with the same target \[Fragment crystallizable Receptor-like 5 (FcRH5)\] Dose finding portion: Prior treatment with any BCMA-directed immunotherapy will not be exclusionary, as described in the protocol Dose expansion portion: Prior treatment with any T cell-engaging bispecific antibody directed against BCMA will be exclusionary, as described in the protocol NOTE: Other protocol defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    42 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Montpellier - Departement D'Hematologie

    RECRUITING

    Montpellier, 34295, France

  • CHU de Lille - Rue Michel Polonovski

    SUSPENDED

    Lille, Nord, 59037, France

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    RECRUITING

    Poitiers, New Aquitaine, 86021, France

  • Centre Hospitalier Universitaire Angers

    RECRUITING

    Angers, 49933, France

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Clinica Universidad de Navarra - Madrid

    RECRUITING

    Madrid, 28027, Spain

  • Dana Farber/Harvard Cancer Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Evangelismos General Hospital

    RECRUITING

    Athens, Attica, 10676, Greece

  • General Hospital of Athens Alexandra

    RECRUITING

    Athens, 11528, Greece

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, 91120, Israel

  • Hopital Necker

    RECRUITING

    Paris, Île-de-France Region, 75015, France

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Santiago

    RECRUITING

    Santiago de Compostela, A Coruna, 15706, Spain

  • Hospital Germans Trias i Pujol

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Hospital Henri Mondor

    RECRUITING

    Créteil, Île-de-France Region, 94000, France

  • Hospital Universitario HM Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • Hospital Universitario Marques de Valdecilla

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Quiron Salud Madrid

    RECRUITING

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Ramon y Cajal - Servicio de Psiquiatria

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Indiana University Health Simon Cancer Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals,

    RECRUITING

    Barcelona, 08908, Spain

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Nantes University Hospital

    RECRUITING

    Nantes, Pays de la Loire Region, 44093, France

  • New York Presbyterian Hospital Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Rambam Health Care Campus

    RECRUITING

    Haifa, 3109601, Israel

  • Saint Antoine Hospital

    RECRUITING

    Paris, 75571, France

  • Saint Louis Hospital

    RECRUITING

    Paris, Île-de-France Region, 75010, France

  • Scripps Clinic Torrey Pines

    RECRUITING

    La Jolla, California, 92037, United States

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, Central District, 5265601, Israel

  • The Ohio State University James Cancer Hospital

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Universitaru Hospital La Princesa

    RECRUITING

    Madrid, 28006, Spain

  • University Hospital and Research Institute

    RECRUITING

    Madrid, 28041, Spain

  • University Hospital of Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Texas Southwestern

    RECRUITING

    Dallas, Texas, 75390, United States

  • VA Puget Sound Health Care System

    RECRUITING

    Seattle, Washington, 98108, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Weill Cornell Medicine/New York Presbyterian Hospital

    RECRUITING

    New York, New York, 10021, United States

  • Winship Cancer Institute of Emory University

    RECRUITING

    Atlanta, Georgia, 30004, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.