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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

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

Qualifiers

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

Disqualifiers

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

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

Trial design

Treatments tested in this trial

  • Linvoseltamab

Treatment groups

220 Participants
are divided into 4 treatment groups

Sponsors and collaborators