ClinicalTrials.gov record NCT06292780
A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)
A Phase 1/2 Study of Linvoseltamab in Patients With Relapsed or Refractory Systemic Light Chain Amyloidosis
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 1/2 interventional study gives the investigational drug linvoseltamab to adults with relapsed or refractory systemic light chain (AL) amyloidosis who have received prior therapy. Phase 1 uses small dose-escalation cohorts to study side effects and find recommended doses. Phase 2 expands into randomized dose groups (low vs high) to continue safety assessment and evaluate blood and organ responses. The study also measures drug levels and whether the body makes antibodies to the drug.
What it is studying. The study is testing linvoseltamab (an anti-BCMA × anti‑CD3 bispecific antibody) to determine safety, dose limits, recommended dosing for further study, and whether the drug produces hematologic responses and organ (heart or kidney) improvements in people with relapsed or refractory AL amyloidosis. It will also measure how much drug is in the blood over time and whether participants develop anti-drug antibodies, and will track side effects and serious adverse events.
What the researchers hope to learn. To find safe and tolerable dosing of linvoseltamab for people with relapsed or refractory AL amyloidosis; to measure hematologic responses (including complete response rates), cardiac and renal responses, duration of response, progression timelines, and incidence and severity of adverse events; and to characterize drug levels in blood and development of anti-drug antibodies. These data aim to inform future research and dosing decisions.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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)
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Linvoseltamab
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion 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
Exclusion criteria
- 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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will receive the study drug linvoseltamab at a dose determined by the study (Phase 1 uses dose escalation; Phase 2 randomizes to low or high dose). They will have regular safety and disease assessments including blood tests, organ assessments for heart and kidney function. The registry mentions bone marrow biopsy and imaging only among its screening requirements. The study will also measure drug levels and check for the body making antibodies to the drug. Follow‑up visits and assessments continue for months to years (outcomes are tracked up to several years).
How the study is structured. Interventional, open-label Phase 1/2 trial. Phase 1: non-randomized dose escalation in small cohorts to assess dose-limiting toxicities and find recommended doses. Phase 2: dose-expansion with participants randomized 1:1 between a low-dose and a high-dose regimen to compare responses and safety. No masking (participants and investigators know the assigned dose). Outcomes include hematologic and organ responses, adverse events, drug levels, and anti-drug antibodies with multi-year follow-up.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in Greece, South Korea, Spain, Taiwan, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on AL amyloidosis
Important dates
- Study start
- Aug 7, 2024
- Primary completion
- Aug 20, 2028 (estimated)
- Study completion
- Feb 20, 2035 (estimated)
- Target enrollment
- 220 participants (estimated)
- Last updated on registry
- Aug 18, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Regeneron Pharmaceuticals
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Clinical Trials Administrator 📞 844-734-6643 ✉ clinicaltrials@regeneron.com
Participating sites (21)
- City of HopeRecruiting
Duarte, California, 91010 · United States
- Colorado Blood Cancer Institute/SCRIRecruiting
Denver, Colorado, 80218 · United States
- Boston Medical CenterRecruiting
Boston, Massachusetts, 02118 · United States
- Karmanos Cancer InstituteRecruiting
Detroit, Michigan, 48201 · United States
- Roswell Park Comprehensive Cancer CenterRecruiting
Buffalo, New York, 14263 · United States
- Ohio State UniversityRecruiting
Columbus, Ohio, 43210 · United States
- SCRI Oncology PartnersRecruiting
Nashville, Tennessee, 37203 · United States
- MD Anderson Cancer CenterRecruiting
Houston, Texas, 77030 · United States
- National and Kapodistrian University of AthensRecruiting
Athens, 11528 · Greece
- Seoul National University HospitalRecruiting
Seoul, 03080 · South Korea
Terms used on this page · explanations by MedicalUpdates.ai
- study drug
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- Phase 1
- An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
- Phase 2
- A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
- difference between involved and uninvolved free light chains
- The difference between the abnormal ('involved') and normal ('uninvolved') free light chain levels in the blood. Used in some conditions to decide whether disease is measurable and to track response.
- prior therapy
- Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
- during screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- ECOG
- A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- exclusion criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- Key Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials