Relapsed/Refractory Systemic Light Chain Amyloidosis study: Linvoseltamab
Official title A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)
ClinicalTrials.gov ID: NCT06292780
What this study is testing
What is Linvoseltamab?
Linvoseltamab is an investigational injectable medicine being studied for relapsed or refractory systemic light chain amyloidosis. Linvoseltamab is designed to target B‑cell maturation antigen and CD3 to engage immune cells.
Also referred to as REGN5458, Lynozyfic™.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find the safest dose and see if linvoseltamab can reduce the abnormal proteins that damage organs, improve heart or kidney function, and understand its side effects and how the body handles the drug.
- Who it's for
- Adults with relapsed or refractory systemic light chain amyloidosis who have tried other therapies.
- What's involved
- Participants will receive linvoseltamab in two phases, with regular clinic visits, blood tests, and monitoring for side effects and organ function.
- Time commitment
- The study lasts about 2 years, with frequent visits in the first months and then periodic follow‑ups for up to 24 months.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
- Known active infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first administration of study drug NOTE...
See the full eligibility criteria
- 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 Key
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Denver, Colorado, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Buffalo, New York, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Athens, Greece
- Seoul, South Korea
- Palma, Balearic Islands, Spain
- Pamplona, Navarre, Spain
- Gijón, Principality of Asturias, Spain
- Barcelona, Spain
- Valencia, Spain
- Taipei, Taiwan
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Denver, Colorado, United States; Boston, Massachusetts, United States; Detroit, Michigan, United States; Buffalo, New York, United States; Columbus, Ohio, United States and 11 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.