A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)
NCT ID: NCT06292780
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
220 participants
INTERVENTIONAL
2024-08-07
2035-02-20
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1: Cohort 1: Low Dose
Dose Escalation: Non-Randomized
Linvoseltamab
anti-B-cell maturation antigen x anti-Cluster of differentiation 3 bispecific antibody
Phase 1: Cohort 2: High Dose
Dose Escalation: Non-Randomized
Linvoseltamab
anti-B-cell maturation antigen x anti-Cluster of differentiation 3 bispecific antibody
Phase 2: Low Dose
Dose Expansion: Participants will be randomized in a 1:1 ratio
Linvoseltamab
anti-B-cell maturation antigen x anti-Cluster of differentiation 3 bispecific antibody
Phase 2: High Dose
Dose Expansion: Participants will be randomized in a 1:1 ratio
Linvoseltamab
anti-B-cell maturation antigen x anti-Cluster of differentiation 3 bispecific antibody
Interventions
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Linvoseltamab
anti-B-cell maturation antigen x anti-Cluster of differentiation 3 bispecific antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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2023-507809-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
R5458-ONC-2274
Identifier Type: -
Identifier Source: org_study_id
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