Testing linvoseltamab for treating relapsed or refractory AL amyloidosis in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of an experimental drug called linvoseltamab in adults suffering from relapsed or refractory systemic light chain amyloidosis (AL amyloidosis). The study is divided into two phases: Phase 1 focuses on determining the recommended doses and assessing side effects in a small group of participants, while Phase 2 expands the participant pool to further evaluate the drug's effectiveness and safety. The trial also aims to measure improvements in abnormal proteins and organ function, particularly in the heart and kidneys, among those treated with linvoseltamab.

Why it matters

Who can join: the full rules

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 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

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• Colorado Blood Cancer Institute/SCRI
  Denver, Colorado, United States Recruiting
• Boston Medical Center
  Boston, Massachusetts, United States Recruiting
• Karmanos Cancer Institute
  Detroit, Michigan, United States Recruiting
• Roswell Park Comprehensive Cancer Center
  Buffalo, New York, United States Recruiting
• Ohio State University
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• REGN17372 plus linvoseltamab tolerability for adults with relapsed/refractory multiple myeloma

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• Linvoseltamab vs. Daratumumab in high-risk smoldering myeloma

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• Response-based lowering of linvoseltamab doses for relapsed or refractory multiple myeloma

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• Linvoseltamab versus standard daratumumab‑lenalidomide‑dexamethasone for adults with newly diagnosed, transplant‑ineligible multiple myeloma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.