A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis) (LINKER-AL2) LINKER-AL2

What's the purpose of this trial?

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. 

This trial is currently open and accepting patients.

What will happen during the trial?

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)

 

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 1/2

Enrollment: 220 patients (estimated)

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Published Results

First results from the phase 1/2 LINKER-AL2 trial of linvoseltamab (LINVO) in patients (pts) with relapsed or refractory (RR) systemic light chain (AL) amyloidosis.

May 27, 2026

As of data cut-off (DCO) August 25, 2025, 20 pts (median age, 64 years; prior daratumumab therapy, 60.0%) received LINVO 80 mg (n=7) or 240 mg (n=13), with a median follow-up of 9.6 (range 1.1–25.0) weeks. No DLTs or ICANS occurred. All pts had ≥1 treatment-emergent adverse event (TEAE; Grade (Gr) ≥3, 55.0%). One pt with prior cardiac disorder discontinued (Gr 5 ventricular fibrillation, unrelated to LINVO). Most common TEAEs were CRS (50.0%; Gr 1, 35.0%; Gr 2, 15.0%) and infusion-related reactions (45.0%; Gr 1, 25.0%; Gr 2, 20.0%), most during step-up dosing. LINVO elicited rapid responses (Table): hOR rates were 100% (80 mg: ≥hCR, 57.1%) and 92.3% (240 mg: ≥hCR, 38.5%), which are expected to deepen with longer follow-up. Most pts reached iFLC <20 mg/L (80 mg: 100%; 240 mg: 84.6%).

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

City of Hope

Upland, CA

Open and Accepting

Colorado

Colorado Blood Cancer Institute Sarah Cannon at Presbyterian/St. Luke's Medical Center (HealthONE)

Denver, CO

Open and Accepting

Massachusetts

Boston Medical Center

Boston, MA

Open and Accepting

Michigan

Karmanos Cancer Institute McLaren Greater Lansing

Lansing, MI

Open and Accepting

New York

Roswell Park Cancer Institute

Buffalo, NY

Open and Accepting

Ohio

Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute

Columbus, OH

Open and Accepting

Tennessee

Sarah Cannon Research Institute TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting
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