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NCT Number: NCT06292780

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

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)

Recruiting

Interested in participating?

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Key information

Conditions

Relapsed/Refractory Systemic Light Chain Amyloidosis Blood Protein Disorders Cardiovascular Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National and Kapodistrian University of Athens, Athens, Greece

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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

Treatment and study plan

Linvoseltamab

Drug

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

Other names: REGN5458, Lynozyfic™

Primary outcomes

  1. Incidence of dose-limiting toxicity (DLTs)

    Time frame: Up to 28 Days

    Phase 1

  2. Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC)

    Time frame: Up to 3 years

    Phase 2

Secondary outcomes

  1. Achievement of hematologic CR, as determined by the IRC

    Time frame: Up to 3 years

    Phase 1

  2. Achievement of hematologic very good partial response (VGPR) or better response (CR + VGPR), as determined by the IRC

    Time frame: Up to 3 years

  3. Achievement of overall hematologic response (PR or better), as determined by the IRC

    Time frame: Up to 3 years

  4. Time to initial hematologic response

    Time frame: Up to 3 years

  5. Time to best hematologic response

    Time frame: Up to 3 years

  6. Duration of hematologic response (ie, best response, VGPR or better, overall response), as determined by the IRC

    Time frame: Up to 7 years

  7. Hematologic progression-free survival (PFS)

    Time frame: Up to 7 years

  8. Incidence of death

    Time frame: Up to 7 years

  9. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to 39 months

  10. Severity of TEAEs

    Time frame: Up to 39 months

  11. Incidence of serious adverse events (SAEs)

    Time frame: Up to 39 months

  12. Severity of SAEs

    Time frame: Up to 39 months

  13. Incidence of adverse events of special interest (AESIs)

    Time frame: Up to 39 months

  14. Severity of AESIs

    Time frame: Up to 39 months

  15. Achievement of overall hematologic response (PR or better), as determined by the IRC in dose regimen 1 vs 2

    Time frame: Up to 39 months

    Phase 2

  16. Incidence of TEAEs in dose regimen 1 vs 2

    Time frame: Up to 39 months

    Phase 2

  17. Severity of TEAEs in dose regimen 1 vs 2

    Time frame: Up to 39 months

    Phase 2

  18. Incidence of SAEs in dose regimen 1 vs 2

    Time frame: Up to 39 months

    Phase 2

  19. Severity of SAEs in dose regimen 1 vs 2

    Time frame: Up to 39 months

    Phase 2

  20. Incidence of AESIs in dose regimen 1 vs 2

    Time frame: Up to 39 months

    Phase 2

  21. Severity of AESIs in dose regimen 1 vs 2

    Time frame: Up to 39 months

    Phase 2

  22. Time from treatment initiation to hematologic disease progression as determined by the IRC

    Time frame: Up to 7 years

  23. Time from treatment initiation to cardiac deterioration, as determined by the IRC

    Time frame: Up to 7 years

  24. Time from treatment initiation to kidney deterioration as determined by the IRC

    Time frame: Up to 7 years

  25. Time from treatment initiation to death as determined by the IRC

    Time frame: Up to 7 years

  26. Time from initiation of treatment to date of death from any cause

    Time frame: Up to 7 years

  27. Achievement of renal response in participants with renal involvement at baseline, as determined by IRC

    Time frame: Up to 7 years

  28. Achievement of cardiac response in participants with cardiac involvement at baseline, as determined by IRC

    Time frame: Up to 7 years

  29. Time to first renal response in participants with renal involvement at baseline

    Time frame: Up to 7 years

  30. Time to first cardiac response in participants with cardiac involvement at baseline

    Time frame: Up to 7 years

  31. Linvoseltamab concentration in serum over time

    Time frame: Up to 39 months

  32. Incidence of anti-drug antibodies (ADAs) to linvoseltamab over time

    Time frame: Up to 39 months

  33. Titers of ADAs to linvoseltamab over time

    Time frame: Up to 39 months

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1/2 Study of Linvoseltamab in Patients With Relapsed or Refractory Systemic Light Chain Amyloidosis

Acronym: LINKER-AL2

Important dates

Study start
2024
Primary completion
2028
Study completion
2035
First posted
Mar 5, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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