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

NCT06292780 · tracked via the Priya Life Science UK tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 1/2

Started

2024-08-07

Last updated

2026-08-18

Condition(s) studied

Relapsed/Refractory Systemic Light Chain Amyloidosis

Investigational drug(s) / intervention(s)

Linvoseltamab

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

Study summary

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)

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Key Inclusion 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 Key Exclusion Criteria: 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 NOTE: Other protocol defined inclusion/exclusion criteria apply

Primary outcome measure(s)

Incidence of dose-limiting toxicity (DLTs) — Up to 28 Days
Phase 1
Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC) — Up to 3 years
Phase 2

Trial sites (21)

Facility	City	Region	Status
City of Hope	Duarte	California	Recruiting
Colorado Blood Cancer Institute/SCRI	Denver	Colorado	Recruiting
Boston Medical Center	Boston	Massachusetts	Recruiting
Karmanos Cancer Institute	Detroit	Michigan	Recruiting
Roswell Park Comprehensive Cancer Center	Buffalo	New York	Recruiting
Ohio State University	Columbus	Ohio	Recruiting
SCRI Oncology Partners	Nashville	Tennessee	Recruiting
MD Anderson Cancer Center	Houston	Texas	Recruiting
National and Kapodistrian University of Athens	Athens	Greece	Recruiting
Seoul National University Hospital	Seoul	South Korea	Recruiting
Asan Medical Center	Seoul	South Korea	Recruiting
Samsung Medical Center	Seoul	South Korea	Recruiting
Seoul St. Mary's Hospital - The Catholic University of Korea	Seoul	South Korea	Recruiting
Hospital Universitari Son Espases	Palma	Balearic Islands	Recruiting
Clinica Universidad de Navarra - Pamplona	Pamplona	Navarre	Recruiting
Hospital de Cabuenes	Gijón	Principality of Asturias	Recruiting
Universität de Barcelona- Institut d' Investigacions Biomediques August Pi i Sunyer (IDIBAPS)	Barcelona	Spain	Recruiting
University Hospital La Fe	Valencia	Spain	Recruiting
Taipei Municipal Wan Fang Hospital	Taipei	Taiwan	Recruiting
University College London Hospitals	London	United Kingdom	Recruiting
The Christie NHS Foundation Trust	Manchester	United Kingdom	Withdrawn

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A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy Recruiting

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma Recruiting

A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06292780 on ClinicalTrials.gov ↗ ← All trials in the UK