Actively Recruiting
A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)
Led by Regeneron Pharmaceuticals · Updated on 2026-04-29
220
Participants Needed
19
Research Sites
549 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of AL amyloidosis
- Measurable disease by serum difference between involved and uninvolved free light chains
- Previously treated with at least one therapy and require further treatment
- N-terminal pro b-type natriuretic peptide (NT-proBNP) level 8500 ng/L at screening
- Adequate liver, blood, kidney, and heart function
- Eastern Cooperative Oncology Group (ECOG) performance score of 2 or less at screening
You will not qualify if you...
- History of non-AL amyloidosis
- More than 60% plasmacytosis in bone marrow biopsy or aspirate
- Presence of lytic bone lesions or extramedullary plasmacytoma on imaging
- Heart attack within 6 months before screening
- Active infection requiring hospitalization or IV anti-infective treatment within 28 days before study drug administration
- Other protocol-defined exclusion criteria apply
AI-Screening
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Trial Site Locations
Total: 19 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Colorado Blood Cancer Institute/SCRI
Denver, Colorado, United States, 80218
Actively Recruiting
3
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
4
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
5
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
6
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
7
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
National and Kapodistrian University of Athens
Athens, Greece, 11528
Actively Recruiting
9
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
10
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
11
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
12
Seoul St. Mary's Hospital - The Catholic University of Korea
Seoul, South Korea, 065791
Actively Recruiting
13
Hospital Universitari Son Espases
Palma, Balearic Islands, Spain, 07120
Actively Recruiting
14
Clinica Universidad de Navarra - Pamplona
Pamplona, Navarre, Spain, 31008
Actively Recruiting
15
Hospital de Cabuenes
Gijón, Principality of Asturias, Spain, 33203
Actively Recruiting
16
Universität de Barcelona- Institut d' Investigacions Biomediques August Pi i Sunyer (IDIBAPS)
Barcelona, Spain, 08036
Actively Recruiting
17
University Hospital La Fe
Valencia, Spain, 46026
Actively Recruiting
18
University College London Hospitals
London, United Kingdom, NW1 2PG
Actively Recruiting
19
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BQ
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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