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NCT06292780RecruitingPhase 1/2

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Oct 2026

Brief summary (registry, in English)

-Phase 1: To assess the safety, tolerability and to determine the recommended phase 2 dose regimens (RP2DRs) of linvoseltamab in participants with relapsed or refractory AL amyloidosis. -Phase 2: To evaluate the effect of linvoseltamab on hematologic complete response in participants with relapsed or refractory AL amyloidosis

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
57 (estimated)
First submitted
7 Mar 2024
Start date
7 Aug 2024
Lead sponsor
Regeneron Pharmaceuticals Inc.
NCT number
NCT06292780
EU CT number
2023-507809-34-00

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 57
  • 18 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • History of other non-AL amyloidosis

Other

  • 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
  • NOTE: Other protocol defined exclusion criteria apply

Who the study is looking for

  • 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
  • NOTE: Other protocol defined inclusion criteria apply

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyNot yet recruiting
Universitaetsklinikum Essen (AoR)
Coordinator of this site? Confirm its status
EssenGermanyNot yet recruiting
Universitaetsklinikum Heidelberg AöR
Coordinator of this site? Confirm its status
HeidelbergGermanyNot yet recruiting
Universitaetsklinikum Wuerzburg AöR
Coordinator of this site? Confirm its status
WuerzburgGermanyNot yet recruiting
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario de Cabueñes
Coordinator of this site? Confirm its status
GijónSpainRecruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario De Móstoles
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MóstolesSpainRecruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainRecruiting
University Hospital Son Espases
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PalmaSpainRecruiting
Clínica Universidad de navarra
Coordinator of this site? Confirm its status
PamplonaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Alexandra Hospital
Coordinator of this site? Confirm its status
AthensGreeceRecruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsNot yet recruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsNot yet recruiting
Radboud universitair medisch centrum Stichting
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NijmegenNetherlandsNot yet recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Coordinator of this site? Confirm its status
RotterdamNetherlandsNot yet recruiting
Universitair Medisch Centrum Utrecht
Coordinator of this site? Confirm its status
UtrechtNetherlandsNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.