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

Inclusion Criteria6

  • Confirmed diagnosis of AL amyloidosis, as described in the protocol
  • Measurable disease as defined by serum difference between involved and uninvolved free light chains (dFLC) concentration, as described in the protocol
  • Previously treated after at least 1 prior therapy and requiring further treatment as assessed by the Investigator
  • N-terminal pro b-type natriuretic peptide (NT-proBNP) ≤8500 ng/L during screening
  • Adequate hepatic, hematologic, renal, and cardiac function, as described in the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening

Exclusion Criteria5

  • History of other non-AL amyloidosis
  • Greater than 60% plasmacytosis on a bone marrow biopsy and/or aspirate during screening
  • Presence of lytic bone lesion(s) or extramedullary plasmacytoma on imaging during screening
  • Myocardial infarction within the past 6 months prior to the first screening visit
  • Known active infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first administration of study drug

Interventions

DRUGLinvoseltamab

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


Locations(18)

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

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