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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT06292780

Registry updated: 2026-08-18
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Description

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)

Interventions

  • Linvoseltamab (Drug)
    anti-B-cell maturation antigen x anti-Cluster of differentiation 3 bispecific antibody

Eligibility criteria

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

Conditions

Relapsed/Refractory Systemic Light Chain Amyloidosis

Locations

  • City of Hope — Duarte, California, United States
  • Colorado Blood Cancer Institute/SCRI — Denver, Colorado, United States
  • Boston Medical Center — Boston, Massachusetts, 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
  • Taipei Municipal Wan Fang Hospital — Taipei, Taiwan
  • University College London Hospitals — London, United Kingdom
  • The Christie NHS Foundation Trust — Manchester, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record