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

Last updated: March 28, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

1/2

Condition

Amyloidosis

Treatment

Linvoseltamab

Clinical Study ID

NCT06292780
R5458-ONC-2274
2023-507809-34-00
  • Ages > 18
  • All Genders

Study 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

Inclusion

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 uninvolvedfree light chains (dFLC) concentration, as described in the protocol

  3. Previously treated after at least 1 prior therapy and requiring further treatment asassessed 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 theprotocol

  6. Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening

Exclusion

Key Exclusion Criteria:

  1. History of other non-AL amyloidosis

  2. Greater than 60% plasmacytosis on a bone marrow biopsy and/or aspirate duringscreening

  3. Presence of lytic bone lesion(s) or extramedullary plasmacytoma on imaging duringscreening

  4. Myocardial infarction within the past 6 months prior to the first screening visit

  5. Known active infection requiring hospitalization or treatment with IVanti-infectives within 28 days of first administration of study drug

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Design

Total Participants: 220
Treatment Group(s): 1
Primary Treatment: Linvoseltamab
Phase: 1/2
Study Start date:
August 07, 2024
Estimated Completion Date:
February 20, 2035

Connect with a study center

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

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

    Seoul, 065791
    Korea, Republic of

    Active - Recruiting

  • Hospital de Cabuenes

    Gijon, Asturias 33203
    Spain

    Active - Recruiting

  • Hospital Universitari Son Espases

    Palma, Balearic Islands 07120
    Spain

    Active - Recruiting

  • Universitary Hospital Son Espases

    Palma, Balearic Islands 07120
    Spain

    Active - Recruiting

  • University Hospital Son Espases

    Palma, Balearic Islands 07120
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

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

    Barcelona, 08036
    Spain

    Active - Recruiting

  • University Hospital La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • University College London Hospitals

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BQ
    United Kingdom

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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