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Recruiting Phase 1 Interventional

A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

ClinicalTrials.gov ID: NCT05137054

Public ClinicalTrials.gov record NCT05137054. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 9:23 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again. In the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies). This study is the first time linvoseltamab will be combined with other cancer therapies. The main goal is to understand if linvoseltamab can be given safely with other cancer treatments, and if so, what dose of linvoseltamab should be used for each combination. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab in combination with each of the other cancer treatments have improvement of their multiple myeloma * What side effects may happen from taking linvoseltamab together with another cancer treatment * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

Study identification

NCT ID
NCT05137054
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Regeneron Pharmaceuticals
Industry
Enrollment
317 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 16, 2022
Primary completion
Mar 24, 2028
Completion
Mar 23, 2032
Last update posted
Jul 7, 2026

2022 – 2032

United States locations

U.S. sites
13
U.S. states
11
U.S. cities
12
Facility City State ZIP Site status
Scripps Clinic Torrey Pines La Jolla California 92037 Recruiting
Winship Cancer Institute of Emory University Atlanta Georgia 30004 Recruiting
Indiana University Health Simon Cancer Center Indianapolis Indiana 46202 Recruiting
Dana Farber/Harvard Cancer Center Boston Massachusetts 02215 Recruiting
Karmanos Cancer Institute Detroit Michigan 48201 Recruiting
Mayo Clinic Rochester Minnesota 55905 Recruiting
Weill Cornell Medicine/New York Presbyterian Hospital New York New York 10021 Recruiting
New York Presbyterian Hospital Columbia University Medical Center New York New York 10032 Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599 Recruiting
Wake Forest University Health Sciences Winston-Salem North Carolina 27157 Recruiting
The Ohio State University James Cancer Hospital Columbus Ohio 43210 Recruiting
University of Texas Southwestern Dallas Texas 75390 Recruiting
VA Puget Sound Health Care System Seattle Washington 98108 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05137054, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 7, 2026 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05137054 live on ClinicalTrials.gov.

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