Linvoseltamab for Relapsed or Refractory AL Amyloidosis

This study is looking into a new experimental drug called linvoseltamab for adults with AL amyloidosis that has come back or didn't respond to previous treatments. Linvoseltamab is a special antibody designed to target certain cells. The study aims to find out if linvoseltamab is safe and how well it works. To join, you must have a confirmed diagnosis of AL amyloidosis, have measurable disease (meaning doctors can track your condition), and have already received at least one other treatment. The study will first test different doses of linvoseltamab in a small group, then give it to more people to further check its safety and effectiveness. The main goals are to see if there are any serious side effects and if the drug can lead to a complete blood response, which means the disease is no longer detectable in your blood.

Study design
This is an interventional study with a planned enrollment of 220 participants. It has two phases: Phase 1 will determine safe doses, and Phase 2 will further assess safety and effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the achievement of a complete blood response for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06292780

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Regeneron Pharmaceuticals
~220 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Linvoseltamab

At a glance

Recruiting sites
20 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose-limiting toxicity (DLTs)
Measured over Up to 28 Days
+1 more outcome measured
Relapsed/Refractory Systemic Light Chain Amyloidosis
21 sites across 16 states
South Korea4
Spain2
United Kingdom2
California1
Colorado1
Massachusetts1
Michigan1
New York1
  • Clinical Trial Management · STUDY_DIRECTOR · Regeneron Pharmaceuticals

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  • Incidence of dose-limiting toxicity (DLTs)Up to 28 Days

    Phase 1

  • Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC)Up to 3 years

    Phase 2