Recruiting
Phase 1
Phase 2

Linvoseltamab

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT06292780

Conditions

Relapsed/Refractory Systemic Light Chain Amyloidosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Linvoseltamab

Study Details

Brief 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)

Conditions

Relapsed/Refractory Systemic Light Chain Amyloidosis

Study ID

NCT06292780

Start date

Aug 7, 2024

Status verified date

Aug, 2026

Completion date

Feb 20, 2035

Anticipated

Primary completion date

Aug 20, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

220 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1: Cohort 1: Low Dose

Dose Escalation: Non-Randomized

experimental: Phase 1: Cohort 2: High Dose

Dose Escalation: Non-Randomized

experimental: Phase 2: Low Dose

Dose Expansion: Participants will be randomized in a 1:1 ratio

experimental: Phase 2: High Dose

Dose Expansion: Participants will be randomized in a 1:1 ratio

Interventions

Linvoseltamab

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

Primary outcome measure

  • Incidence of dose-limiting toxicity (DLTs) [ Time Frame: Up to 28 Days ]
  • Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Colorado Blood Cancer Institute/SCRI

Recruiting

Denver, Colorado, United States, 80218

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14263

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-18.