ClinicalTrials.gg
Sign In
Not yet recruitingNCT07901725LINKER-AL1Updated Oct 28, 2026

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

A Phase 3 interventional study of Linvoseltamab and Daratumumab in Newly Diagnosed Amyloidosis and Amyloidosis Stage I-IIIA, sponsored by Regeneron Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
382
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

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)
02

Conditions studied

  • Newly Diagnosed Amyloidosis
  • Amyloidosis Stage I-IIIA

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
03

In context

Immunoglobulin Light-chain Amyloidosis

239 studies on the registry are indexed under Immunoglobulin Light-chain Amyloidosis; 63 are open to participants now.

This study's planned enrollment of 382 is above the median of 39 across 169 interventional studies indexed under Immunoglobulin Light-chain Amyloidosis.

Browse Immunoglobulin Light-chain Amyloidosis studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.

Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.

Browse Regeneron Pharmaceuticals studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Confirmed diagnosis of AL amyloidosis as documented historically, as described in the protocol
  2. as defined by serum difference between involved and uninvolved free light chains (dFLC), as described in the protocol
  3. Adequate hematologic, renal, and hepatic function, as described in the protocol
  4. (ECOG) performance score ≤2 at screening

Key Exclusion Criteria:

  1. History of other non-AL amyloidosis
  2. Greater than or equal to 60% plasmacytosis on a bone marrow and/or aspirate during screening
  3. Presence of lytic bone lesion(s) or plasmacytoma (extramedullary or paraskeletal) on imaging during screening
  4. \<40% by echocardiogram during screening, congestive heart failure and acute coronary syndrome or myocardial infarction within 6 months of screening
  5. Prior AL amyloidosis treatment

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
382 participants (estimated)

Study arms

  • Experimental
    Linvoseltamab

    Drug: Linvoseltamab

  • Active comparator
    Dara-Vcd

    Drug: Daratumumab · Drug: Bortezomib · Drug: Cyclophosphamide · Drug: Dexamethasone

Interventions

  • DrugLinvoseltamab

    Administered per the protocol

    Also known as: REGN5458, Lynozyfic™

  • DrugDaratumumab

    Administered per the protocol

    Also known as: Darzalex®, Darzalex Faspro™

  • DrugBortezomib

    Administered per the protocol

    Also known as: Velcade®

  • DrugCyclophosphamide

    Administered per the protocol

    Also known as: Cytoxan®, Neosar®, Endoxan®

  • DrugDexamethasone

    Administered per the protocol

    Also known as: Dexahexal®, Decadron®

06

What researchers measure

Primary outcomes

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

    Part 1

    Time frame: Up to 7 years

  2. Severity of TEAEs

    Part 1

    Time frame: Up to 7 years

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

    Part 1

    Time frame: Up to 7 years

  4. Severity of AESI

    Part 1

    Time frame: Up to 7 years

  5. Occurrence of Serious Adverse Events (SAEs)

    Part 1

    Time frame: Up to 7 years

  6. Severity of SAEs

    Part 1

    Time frame: 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

    Time frame: Up to 7 years

Secondary outcomes

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

    Part 1

    Time frame: 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

    Time frame: Up to 7 years

  3. Overall Survival (OS)

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to 7 years

  11. Duration of HemCR per ISA response criteria

    Part 2

    Time frame: Up to 7 years

  12. Time to Next Treatment (TTNT)

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to month 6

  14. Occurrence of TEAEs

    Part 2

    Time frame: Up to 7 years

  15. Severity of TEAEs

    Part 2

    Time frame: Up to 7 years

  16. Occurrence of AESI

    Part 2

    Time frame: Up to 7 years

  17. Severity of AESI

    Part 2

    Time frame: Up to 7 years

  18. Occurrence of SAEs

    Part 2

    Time frame: Up to 7 years

  19. Severity of SAEs

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to 7 years

  26. Change from baseline in FACIT-Fatigue scale

    Part 2

    Time frame: 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

    Time frame: Up to 24 months

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

    Part 2

    Time frame: Up to 24 months

  29. Concentrations of linvoseltamab in serum

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to 7 years

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

    Part 2

    Time frame: Up to 7 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy

Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07901725
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Dec 18, 2026 (estimated)
Primary completion
Jul 25, 2035 (estimated)
Completion
Jul 25, 2035 (estimated)
Last update
Oct 28, 2026

Study contacts

Clinical Trials Administrator
Contact
clinicaltrials@regeneron.com
844-734-6643
Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Linvoseltamab

Other studies in this condition

Immunoglobulin Light-chain Amyloidosis →

Other studies from this sponsor

Regeneron Pharmaceuticals →

Start the discussion