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

Launched by REGENERON PHARMACEUTICALS · Feb 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called linvoseltamab for adults with a condition known as relapsed or refractory systemic light chain amyloidosis (AL amyloidosis). This is a serious illness where harmful proteins build up in the organs, and the trial focuses on patients whose disease has returned or who have not had success with previous treatments. The study is divided into two phases: the first phase will give linvoseltamab to a small group of participants to see how safe it is and what the best dose is, while the second phase will involve more participants to further explore its safety and effectiveness.

To be eligible for the trial, participants must have been diagnosed with AL amyloidosis and have had at least one previous treatment that didn’t work. They should also have certain health criteria, such as healthy liver and kidney function. Throughout the study, participants can expect to receive the study drug and undergo regular monitoring to check for side effects and improvements in their condition. It's important to know that participating in clinical trials helps researchers learn more about new treatments, which could benefit future patients. If you or someone you know is interested, it would be good to discuss this with a healthcare provider.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Confirmed diagnosis of AL amyloidosis, as described in the protocol
• • 2. Measurable disease as defined by serum difference between involved and uninvolved free light chains (dFLC) concentration, as described in the protocol
• • 3. Previously treated after at least 1 prior therapy and requiring further treatment as assessed by the Investigator
• • 4. N-terminal pro b-type natriuretic peptide (NT-proBNP) ≤8500 ng/L during screening
• • 5. Adequate hepatic, hematologic, renal, and cardiac function, as described in the protocol
• • 6. Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening
• Key Exclusion Criteria:
• • 1. History of other non-AL amyloidosis
• • 2. Greater than 60% plasmacytosis on a bone marrow biopsy and/or aspirate during screening
• • 3. Presence of lytic bone lesion(s) or extramedullary plasmacytoma on imaging during screening
• • 4. Myocardial infarction within the past 6 months prior to the first screening visit
• • 5. 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