RecruitingPhase 1Phase 2NCT06292780

A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)

A Phase 1/2 Study of Linvoseltamab in Patients With Relapsed or Refractory Systemic Light Chain Amyloidosis


Sponsor

Regeneron Pharmaceuticals

Enrollment

220 participants

Start Date

Aug 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is researching an experimental drug called linvoseltamab ("study drug"). This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again. The study consists of 2 phases (Phase 1 and Phase 2): * In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2. * In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab have improvement in the abnormal proteins that cause organ problems and for how long * How many participants treated with linvoseltamab have improvement in the heart or kidney and for how long * What the right dosing regimen is for linvoseltamab * What side effects may happen from taking linvoseltamab * 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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called linvoseltamab in adults with AL amyloidosis — a rare disease where abnormal proteins called amyloid build up in organs like the heart, kidneys, and nerves, causing serious damage. This drug targets plasma cells (the cells producing the abnormal protein) using a bispecific antibody approach. **You may be eligible if...** - You have a confirmed diagnosis of AL amyloidosis - You have measurable disease based on blood protein levels - You have received at least one prior treatment for AL amyloidosis - Your heart function is not severely compromised (NT-proBNP level ≤8500 ng/L) - Your liver, blood, kidneys, and heart function meet study thresholds **You may NOT be eligible if...** - You have a different type of amyloidosis (not AL type) - More than 60% of your bone marrow is made up of plasma cells - You have active bone lesions (lytic lesions indicating myeloma) - You have certain active infections or significant organ failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLinvoseltamab

anti-B-cell maturation antigen x anti-Cluster of differentiation 3 bispecific antibody


Locations(19)

City of Hope

Duarte, California, United States

Colorado Blood Cancer Institute/SCRI

Denver, Colorado, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Ohio State University

Columbus, Ohio, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

National and Kapodistrian University of Athens

Athens, Greece

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul St. Mary's Hospital - The Catholic University of Korea

Seoul, South Korea

Hospital Universitari Son Espases

Palma, Balearic Islands, Spain

Clinica Universidad de Navarra - Pamplona

Pamplona, Navarre, Spain

Hospital de Cabuenes

Gijón, Principality of Asturias, Spain

Universität de Barcelona- Institut d' Investigacions Biomediques August Pi i Sunyer (IDIBAPS)

Barcelona, Spain

University Hospital La Fe

Valencia, Spain

University College London Hospitals

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06292780