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NCT06292780: LINKER-AL2

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

Recruiting now Phase 1, PHASE2 Last updated 18 September 2025
What this trial tests

Phase 1, PHASE2 trial testing Linvoseltamab in Relapsed/Refractory Systemic Light Chain Amyloidosis in 220 participants. Currently enrolling.

Timeline
7 August 2024
Primary endpoint
20 August 2028
20 February 2035

Quick facts

Lead sponsorRegeneron Pharmaceuticals
PhasePhase 1, PHASE2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment220
Start date7 August 2024
Primary completion20 August 2028
Estimated completion20 February 2035
Sites18 locations across United Kingdom, United States, Spain, South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Relapsed/Refractory Systemic Light Chain Amyloidosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. An Updated Comprehensive Review on Diseases Associated with Nephrotic Syndromes.
    Wendt R, Sobhani A, Diefenhardt P, Trappe M, et al · · 2024 · cited 8× · PMID 39457572 · DOI 10.3390/biomedicines12102259
  2. Systemic amyloid light‐chain amyloidosis beyond ANDROMEDA: Diagnostic challenges and therapeutic updates
    Wu X, Landau H, Liu J, Cao Y, et al · · 2026
  3. Management of relapsed/refractory AL amyloidosis.
    Ling J, Sidiqi MH, Gertz M. · · 2026 · PMID 41894688 · DOI 10.1182/bloodadvances.2025019223
  4. BCMA CAR-T: From Multiple Myeloma to Light-Chain Amyloidosis.
    Lewis E, Jimenez-Zepeda VH. · · 2025 · PMID 40862787 · DOI 10.3390/curroncol32080418

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Other trials of Linvoseltamab

Trials testing the same drug.

Other Regeneron Pharmaceuticals trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06292780.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing