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New hope for rare protein disease: experimental drug targets relapsed amyloidosis

NCT ID NCT06292780

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study tests an experimental drug called linvoseltamab in 220 people with AL amyloidosis that has returned or not improved after prior therapy. The drug aims to reduce abnormal proteins that damage organs like the heart and kidneys. The trial first finds the safest dose, then checks how well the drug controls the disease and improves organ function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Feb 2035

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

AL amyloidosis plasma cell myeloma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed/refractory systemic light chain amyloidosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Clinica Universidad de Navarra - Pamplona

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Colorado Blood Cancer Institute/SCRI

    RECRUITING

    Denver, Colorado, 80218, United States

  • Hospital Universitari Son Espases

    RECRUITING

    Palma, Balearic Islands, 07120, Spain

  • Hospital de Cabuenes

    RECRUITING

    Gijón, Principality of Asturias, 33203, Spain

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • National and Kapodistrian University of Athens

    RECRUITING

    Athens, 11528, Greece

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Roswell Park Comprehensive Cancer Center

    RECRUITING

    Buffalo, New York, 14263, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Seoul St. Mary's Hospital - The Catholic University of Korea

    RECRUITING

    Seoul, 065791, South Korea

  • Taipei Municipal Wan Fang Hospital

    RECRUITING

    Taipei, 116, Taiwan

  • The Christie NHS Foundation Trust

    WITHDRAWN

    Manchester, M20 4BQ, United Kingdom

  • University College London Hospitals

    RECRUITING

    London, NW1 2PG, United Kingdom

  • University Hospital La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Universität de Barcelona- Institut d' Investigacions Biomediques August Pi i Sunyer (IDIBAPS)

    RECRUITING

    Barcelona, 08036, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.