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/Phase 2
Conditions studied: Relapsed/Refractory Systemic Light Chain Amyloidosis
In brief
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)
Key facts
- Study ID
- NCT06292780
- Run by
- Regeneron Pharmaceuticals
- People needed
- 220
- Starts
- 2024-08-07
- Expected to finish
- 2035-02-20
- Last updated by the study team
- 2026-06-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope — Duarte, California, United States (enrolling)
- Colorado Blood Cancer Institute/SCRI — Denver, Colorado, United States (enrolling)
- Boston Medical Center — Boston, Massachusetts, United States (enrolling)
- Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (enrolling)
- Ohio State University — Columbus, Ohio, United States (enrolling)
- SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- National and Kapodistrian University of Athens — Athens, Greece (enrolling)
- Seoul National University Hospital — Seoul, South Korea (enrolling)
- Asan Medical Center — Seoul, South Korea (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- Seoul St. Mary's Hospital - The Catholic University of Korea — Seoul, South Korea (enrolling)
- Hospital Universitari Son Espases — Palma, Balearic Islands, Spain (enrolling)
- Clinica Universidad de Navarra - Pamplona — Pamplona, Navarre, Spain (enrolling)
- Hospital de Cabuenes — Gijón, Principality of Asturias, Spain (enrolling)
- Universität de Barcelona- Institut d' Investigacions Biomediques August Pi i Sunyer (IDIBAPS) — Barcelona, Spain (enrolling)
- University Hospital La Fe — Valencia, Spain (enrolling)
- University College London Hospitals — London, United Kingdom (enrolling)
- The Christie NHS Foundation Trust — Manchester, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.