At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Linvoseltamab (drug)
- How long the study runs
- Study runs about 126 months (dates as stated)
- About the drug or intervention
- Linvoseltamab — drug: anti-B-cell maturation antigen x anti-Cluster of differentiation 3 bispecific antibody
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is testing whether a medicine called linvoseltamab is safe and works well in adults with relapsed or refractory systemic light chain amyloidosis (AL amyloidosis). This is a condition where the illness has come back or has not responded to earlier treatment. The trial is funded by Regeneron Pharmaceuticals.
Who can take part
- You have a confirmed diagnosis of AL amyloidosis
- Your disease can be measured using a blood test that compares certain light chain proteins
- You have already had at least one previous treatment and your doctor believes you need more treatment
- A heart strain blood test (NT-proBNP) shows a level of 8500 ng/L or less during screening
- Your liver, blood, kidneys and heart are working well enough, as set out in the trial rules
- You are well enough to care for yourself and are up and about for at least half the day (performance score of 2 or less)
Who may not be able to
- You have had another type of amyloidosis that is not AL amyloidosis
- A bone marrow test during screening shows more than 60% plasma cells
- Scans show areas of bone damage or a growth of plasma cells outside the bone marrow
- You have had a heart attack in the past 6 months before the first screening visit
- You have an active infection needing hospital treatment or medicines given through a drip in the past 28 days before the first dose of the study drug
- There are other rules in the trial plan that may also apply
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 220
- Started
- 2024-08-07
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for relapsed/refractory systemic light chain amyloidosis
- • Phase1/Phase2 - 220 participants
- • This study is researching an experimental drug called linvoseltamab ("study drug")
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with relapsed/refractory systemic light chain amyloidosis
Where?
- • London - University College London Hospitals
- • Manchester - The Christie NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study is researching an experimental drug called linvoseltamab ("study drug"). This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again. The study consists of 2 phases (Phase 1 and Phase 2): * In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2. * In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab have improvement in the abnormal proteins that cause organ problems and for how long * How many participants treated with linvoseltamab have improvement in the heart or kidney and for how long * What the right dosing regimen is for linvoseltamab * What side effects may happen from taking linvoseltamab * How much linvoseltamab is in the blood at different times * Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ and requiring further treatment as assessed by the Investigat
What the study is looking for
- ✓Confirmed diagnosis of AL amyloidosis, as described in the protocol
- ✓cancer that can be measured on scans as defined by serum difference between involved and uninvolved free light chains (dFLC)...
- ✓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 liver, blood, kidney, and heart function, as described in the protocol
Who cannot take part
- ✗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...
See the full criteria
Where Is This Study? (2 UK sites)
University College London Hospitals
London NW1 2PG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Christie NHS Foundation Trust
Manchester M20 4BQ, United Kingdom
How to Get in Touch
Clinical Trials Administrator
Sponsor contactCONTACT