Tests linvoseltamab in adults with AL amyloidosis that has returned or not responded
Tests the drug linvoseltamab in adults with AL amyloidosis that returned.
Plain-language title generated from the registry record
Registry title: A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)
Key facts
- Where
- Athens, GreeceSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with AL amyloidosis that has come back or did not respond to earlier treatment and who need treatment again.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Confirmed AL amyloidosis with measurable disease (a measurable gap between involved and uninvolved free light chains), needing more treatment after at least 1 earlier therapy
- Earlier treatment
- At least 1 earlier treatment for AL amyloidosis, and further treatment is needed
- Biomarker or test result
- Measurable disease by the difference between involved and uninvolved free light chains (dFLC); NT-proBNP of 8500 ng/L or lower at screening
Main reasons for not taking part
- History of other, non-AL amyloidosis
- More than 60% plasma cells in the bone marrow at screening
- Bone lesions (lytic) or a plasma cell tumour outside the bone marrow on imaging
- Heart attack in the 6 months before the first screening visit
- Known active infection needing hospital stay or IV anti-infective treatment within 28 days of the first dose
Read by machine on 12 November 2026.
Where in Greece
- Alexandra HospitalAthens, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Regeneron Pharmaceuticals
- Trial code
- NCT06292780EU 2023-507809-34-00
- Record updated
- 18 August 2026
- Original description
This study is researching an experimental drug called linvoseltamab ("study drug").Read full original descriptionShow less
A Phase 1/2 Study of Linvoseltamab in Patients With Relapsed or Refractory Systemic Light Chain Amyloidosis
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)
Inclusion: 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: 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; NOTE: Other protocol defined inclusion/exclusion criteria apply; 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.