Back to Trials
NCT06292780PHASE1, PHASE2Recruiting

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

Regeneron Pharmaceuticals

Start Date

8/7/2024

Completion Date

2/20/2035

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 Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: 1. Confirmed diagnosis of AL amyloidosis, as described in the protocol 2. Measurable disease as defined by serum difference between involved and uninvolved free light chains (dFLC) concentration, as described in the protocol 3. Previously treated after at least 1 prior therapy and requiring further treatment as assessed by the Investigator 4. N-terminal pro b-type natriuretic peptide (NT-proBNP) ≤8500 ng/L during screening 5. Adequate hepatic, hematologic, renal, and cardiac function, as described in the protocol 6. Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening Key Exclusion Criteria: 1. History of other non-AL amyloidosis 2. Greater than 60% plasmacytosis on a bone marrow biopsy and/or aspirate during screening 3. Presence of lytic bone lesion(s) or extramedullary plasmacytoma on imaging during screening 4. Myocardial infarction within the past 6 months prior to the first screening visit 5. Known active infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first administration of study drug NOTE: Other protocol defined inclusion/exclusion criteria apply

Interventions

DRUG

Linvoseltamab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Relapsed/Refractory Systemic Light Chain Amyloidosis

Locations

City of Hope

Duarte, California 91010

United States

Colorado Blood Cancer Institute/SCRI

Denver, Colorado 80218

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York 14263

United States

Ohio State University

Columbus, Ohio 43210

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

National and Kapodistrian University of Athens

Athens, 11528

Greece

Seoul National University Hospital

Seoul, 03080

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

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

Seoul, 065791

South Korea

Hospital Universitari Son Espases

Palma, Balearic Islands 07120

Spain

Clinica Universidad de Navarra - Pamplona

Pamplona, Navarre 31008

Spain

Hospital de Cabuenes

Gijón, Principality of Asturias 33203

Spain

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

Barcelona, 08036

Spain

University Hospital La Fe

Valencia, 46026

Spain

University College London Hospitals

London, NW1 2PG

United Kingdom

The Christie NHS Foundation Trust

Manchester, M20 4BQ

United Kingdom