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

Study Purpose

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 your blood at different times.

- Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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 no more than 4 lines of therapy (including autologous stem cell transplant) 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06292780
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Regeneron Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Trial Management
Principal Investigator Affiliation	Regeneron Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsed/Refractory Systemic Light Chain Amyloidosis

Arms & Interventions

Arms

Experimental: Phase 1: Cohort 1: Low Dose

Dose Escalation: Non-Randomized

Experimental: Phase 1: Cohort 2: High Dose

Dose Escalation: Non-Randomized

Experimental: Phase 2: Low Dose

Dose Expansion: Participants will be randomized in a 1:1 ratio

Experimental: Phase 2: High Dose

Dose Expansion: Participants will be randomized in a 1:1 ratio

Interventions

Drug: - Linvoseltamab

anti-B-cell maturation antigen x anti-Cluster of differentiation 3 bispecific antibody

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Clinical Trials Administrator

clinicaltrials@regeneron.com

844-734-6643

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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