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

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)

Conditions

Relapsed/Refractory Systemic Light Chain Amyloidosis

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Study Overview

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Study Details

Study overview

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)

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

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

Condition
Relapsed/Refractory Systemic Light Chain Amyloidosis
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope, Duarte, California, United States, 91010

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Regeneron Pharmaceuticals,

Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

2035-02-20