RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

Official Title

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

Quick Facts

Study Start:2024-08-07
Study Completion:2035-02-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06292780

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Confirmed diagnosis of AL amyloidosis, as described in the protocol
  2. 2. Measurable disease as defined by serum difference between involved and uninvolved free light chains (dFLC) concentration, as described in the protocol
  3. 3. Previously treated after at least 1 prior therapy and requiring further treatment as assessed by the Investigator
  4. 4. N-terminal pro b-type natriuretic peptide (NT-proBNP) ≤8500 ng/L during screening
  5. 5. Adequate hepatic, hematologic, renal, and cardiac function, as described in the protocol
  6. 6. Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening
  1. 1. History of other non-AL amyloidosis
  2. 2. Greater than 60% plasmacytosis on a bone marrow biopsy and/or aspirate during screening
  3. 3. Presence of lytic bone lesion(s) or extramedullary plasmacytoma on imaging during screening
  4. 4. Myocardial infarction within the past 6 months prior to the first screening visit
  5. 5. Known active infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first administration of study drug

Contacts and Locations

Study Contact

Clinical Trials Administrator
CONTACT
844-734-6643
clinicaltrials@regeneron.com

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-07
Study Completion Date2035-02-20

Study Record Updates

Study Start Date2024-08-07
Study Completion Date2035-02-20

Terms related to this study

Keywords Provided by Researchers

  • Amyloid light-chain (AL)
  • Multiple Myeloma (MM)
  • Pathogenic light chains

Additional Relevant MeSH Terms

  • Relapsed/Refractory Systemic Light Chain Amyloidosis