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Newly Diagnosed AmyloidosisPhase 3LINKER-AL1NCT07901725

Linvoseltamab Versus Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-Vcd) in Adult Participants With Newly Diagnosed Systemic Light Chain Amyloidosis

A Phase 3 study testing Linvoseltamab, Daratumumab and Bortezomib in people with Newly Diagnosed Amyloidosis and Amyloidosis Stage I-IIIA, run by Regeneron Pharmaceuticals.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is researching a Regeneron drug called linvoseltamab ("study drug") alone compared to standard of care (SoC) combination to see if it can help treat participants who are newly diagnosed and previously untreated for systemic amyloid light-chain (AL) amyloidosis. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Linvoseltamab, Daratumumab and Bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
382 participants
Where
No sites listed yet
Study dates
18 Dec 2026to 25 Jul 2035
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of AL amyloidosis as documented historically, as described in the protocol
  • Measurable disease as defined by serum difference between involved and uninvolved free light chains (dFLC), as described in the protocol
  • Adequate hematologic, renal, and hepatic function, as described in the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening

Who cannot join

  • History of other non-AL amyloidosis
  • Greater than or equal to 60% plasmacytosis on a bone marrow biopsy and/or aspirate during screening
  • Presence of lytic bone lesion(s) or plasmacytoma (extramedullary or paraskeletal) on imaging during screening
  • Left ventricular ejection fraction <40% by echocardiogram during screening, congestive heart failure and acute coronary syndrome or myocardial infarction within 6 months of screening
  • Prior AL amyloidosis treatment
  • Note: Other protocol-defined Inclusion/Exclusion criteria apply

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

About this study

Official title: An Open-Label, Randomized Phase 3 Trial of Linvoseltamab Compared With Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-Vcd) in Participants With Newly Diagnosed Systemic Light Chain Amyloidosis

This study is researching a Regeneron drug called linvoseltamab ("study drug") alone compared to standard of care (SoC) combination to see if it can help treat participants who are newly diagnosed and previously untreated for systemic amyloid light-chain (AL) amyloidosis.

The aim of this study is to see if the safety and efficacy of linvoseltamab alone can deliver better disease control and outcomes than Dara-VCd.

Read more

The study is looking at:

  • What side effects linvoseltamab alone might cause
  • How well linvoseltamab works compared to Dara-VCd regimen in terms of reductions of the abnormal proteins that cause AL-amyloidosis that affects the heart and kidney functions and for how long
  • 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)
Keywords
AL Amyloidosis, Amyloid disease, Amyloid Light Chain Amyloidosis, Immunoglobulin Light Chain Amyloidosis, Light Chain Amyloidosis, Newly Diagnosed AL Amyloidosis, Primary Amyloidosis, Systemic Light Chain Amyloidosis, Treatment Naïve AL Amyloidosis, Cardiac stage I-IIIA
Medical subject headings
Immunoglobulin Light-chain Amyloidosis, Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LinvoseltamabDrug

    Also called REGN5458, Lynozyfic™

    Administered per the protocol

  • DaratumumabDrug

    Also called Darzalex®, Darzalex Faspro™

    Administered per the protocol

  • BortezomibDrug

    Also called Velcade®

    Administered per the protocol

  • CyclophosphamideDrug

    Also called Cytoxan®, Neosar®, Endoxan®

    Administered per the protocol

  • DexamethasoneDrug

    Also called Dexahexal®, Decadron®

    Administered per the protocol

Study groups in NCT07901725
Study groupRoleWhat they receive
LinvoseltamabExperimentalNot described
Receives: Drug: Linvoseltamab
Dara-VcdActive comparatorNot described
Receives: Drug: Daratumumab; Drug: Bortezomib; Drug: Cyclophosphamide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Part 1

    Measured: Up to 7 years

  2. Severity of TEAEs

    Part 1

    Measured: Up to 7 years

  3. Occurrence of Adverse Events of Special Interest (AESI)

    Part 1

    Measured: Up to 7 years

  4. Severity of AESI

    Part 1

    Measured: Up to 7 years

  5. Occurrence of Serious Adverse Events (SAEs)

    Part 1

    Measured: Up to 7 years

  6. Severity of SAEs

    Part 1

    Measured: Up to 7 years

  7. Achievement of Hematologic Complete Response (HemCR) per International Society of Amyloidosis (ISA) response criteria as determined by Blinded Independent Review Committee (BIRC)

    Part 2

    Measured: Up to 7 years

Secondary outcomes (31)

  1. Occurrence and timing of grade 2 or 3 Cytokine Release Syndrome (CRS)

    Part 1

    Measured: Up to 28 days following first dose of linvoseltamab

  2. Major Organ Deterioration-Progression-Free Survival (MOD-PFS) as determined by BIRC per modified ISA criteria

    Part 2

    Measured: Up to 7 years

  3. Overall Survival (OS)

    Part 2

    Measured: Up to 7 years

  4. Occurrence of a graded cardiac response in participants who are cardiac response evaluable at trial entry

    Part 2

    Measured: Up to 7 years

  5. Time to cardiac response in participants who are cardiac response evaluable at trial entry

    Part 2

    Measured: Up to 7 years

  6. Occurrence of a graded renal response in participants who are renal response evaluable at trial entry

    Part 2

    Measured: Up to 7 years

  7. Time to first renal response in participants who are renal response evaluable at trial entry

    Part 2

    Measured: Up to 7 years

  8. Achievement of Very Good Partial Response or better (≥VGPR) as assessed by BIRC per ISA response criteria

    Part 2

    Measured: Up to 7 years

  9. Achievement of Partial Response or better (≥PR) as assessed by BIRC per ISA response criteria

    Part 2

    Measured: Up to 7 years

  10. Duration of Response (DOR) per ISA response criteria

    Part 2

    Measured: Up to 7 years

  11. Duration of HemCR per ISA response criteria

    Part 2

    Measured: Up to 7 years

  12. Time to Next Treatment (TTNT)

    Part 2

    Measured: Up to 7 years

  13. Achievement of HemCR as assessed by the BIRC per ISA response criteria

    Part 2

    Measured: Up to month 6

  14. Occurrence of TEAEs

    Part 2

    Measured: Up to 7 years

  15. Severity of TEAEs

    Part 2

    Measured: Up to 7 years

  16. Occurrence of AESI

    Part 2

    Measured: Up to 7 years

  17. Severity of AESI

    Part 2

    Measured: Up to 7 years

  18. Occurrence of SAEs

    Part 2

    Measured: Up to 7 years

  19. Severity of SAEs

    Part 2

    Measured: Up to 7 years

  20. Change from baseline in Short Form Health Survey 36 version 2 (SF-36v2) General Health (GH) scale

    Part 2

    Measured: Up to 7 years

  21. Change from baseline in EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Scale (VAS)

    Part 2

    Measured: Up to 7 years

  22. Change from baseline in SF-36v2 Physical Component Score (PCS)

    Part 2

    Measured: Up to 7 years

  23. Change from baseline in SF-36v2 Physical Functioning (PF) scale

    Part 2

    Measured: Up to 7 years

  24. Change from baseline in SF-36v2 Role Physical (RP) scale

    Part 2

    Measured: Up to 7 years

  25. Change from baseline in FACIT (Functional Assessment of Chronic Illness Therapy)-Dyspnea Part I (Dyspnea Severity Scale)

    Part 2

    Measured: Up to 7 years

  26. Change from baseline in FACIT-Fatigue scale

    Part 2

    Measured: Up to 7 years

  27. Proportion of time with high side-effect bother during treatment per Functional Assessment of Chronic Illness Therapy (FACIT) Item Global Physical (GP) 5 score ≥3

    Part 2

    Measured: Up to 24 months

  28. Occurrence of high side-effect bother at on-treatment visits per FACIT Item GP5 score ≥3

    Part 2

    Measured: Up to 24 months

  29. Concentrations of linvoseltamab in serum

    Part 2

    Measured: Up to 7 years

  30. Occurrence of Anti-Drug Antibodies (ADAs) to linvoseltamab

    Part 2

    Measured: Up to 7 years

  31. Magnitude of Anti-Drug Antibodies (ADAs) to linvoseltamab

    Part 2

    Measured: Up to 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2026
  2. Study start18 Dec 2026 (estimated)
  3. Primary completion25 Jul 2035 (estimated)
  4. Study completion25 Jul 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
382 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07901725
Sponsor's protocol ID
R5458-HM-25146
Other IDs
2026-526156-32-00
Acronym
LINKER-AL1
Status last verified
Oct 2026
First submitted
22 Oct 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linvoseltamab, Daratumumab and Bortezomib in people with Newly Diagnosed Amyloidosis and Amyloidosis Stage I-IIIA, run by Regeneron Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 7 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07901725.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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