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A Trial to Learn if Linvoseltamab is Safe and Works in Adults with Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)
EU CTIS ID: 2023-507809-34-00
What this study is testing
-Phase 1: To assess the safety, tolerability and to determine the recommended phase 2 dose regimens (RP2DRs) of linvoseltamab in participants with relapsed or refractory AL amyloidosis. -Phase 2: To evaluate the effect of linvoseltamab on hematologic complete response in participants with relapsed or refractory AL amyloidosis
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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
- Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening
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: Other protocol defined exclusion criteria apply
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
- NOTE: Other protocol defined inclusion criteria apply
- 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 exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Democratic People's Republic of
- United States
- Canada
- Taiwan
- Australia
- Japan
- 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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Democratic People's Republic of; United States; Canada; Taiwan; Australia; Japan and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.