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.
A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)
At a glance
Conditions
Where it's being run
21 sites across 16 statesStudy leadership
- Clinical Trial Management · STUDY_DIRECTOR · Regeneron Pharmaceuticals
Who to contact
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What this trial measures
- 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