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Monoclonal Antibodies
Linvoseltamab for Amyloidosis (LINKER-AL2 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Key
Confirmed diagnosis of AL amyloidosis, as described in the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called linvoseltamab for patients with AL amyloidosis that has come back or not responded to other treatments. The trial has two phases: Phase 1
Who is the study for?
This trial is for adults with AL amyloidosis who have tried at least one but no more than four treatments and need more therapy. They should have a certain level of abnormal proteins in their blood, be able to perform daily activities with ease or some difficulty (ECOG score ≤2), and have good heart, liver, kidney, and blood function.
What is being tested?
The study tests linvoseltamab in two phases: Phase 1 determines safe dosages through a small group; Phase 2 expands the testing for effectiveness against AL amyloidosis symptoms. It also examines how long improvements last, optimal dosing schedules, potential side effects, drug levels in the blood over time, and if the body resists the drug.
What are the potential side effects?
Possible side effects include reactions related to immune response against linvoseltamab which could reduce its effectiveness or cause additional issues. The study will monitor how much of the drug stays in participants' systems and any organ-specific inflammation or other adverse reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with AL amyloidosis.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC)
Incidence of dose-limiting toxicity (DLTs)
Secondary study objectives
Achievement of hematologic CR, as determined by the IRC
Achievement of overall hematologic response (PR or better), as determined by the IRC in dose regimen 1 vs 2
Incidence of AESIs in dose regimen 1 vs 2
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase 2: Low DoseExperimental Treatment1 Intervention
Dose Expansion: Participants will be randomized in a 1:1 ratio
Group II: Phase 2: High DoseExperimental Treatment1 Intervention
Dose Expansion: Participants will be randomized in a 1:1 ratio
Group III: Phase 1: Cohort 2: High DoseExperimental Treatment1 Intervention
Dose Escalation: Non-Randomized
Group IV: Phase 1: Cohort 1: Low DoseExperimental Treatment1 Intervention
Dose Escalation: Non-Randomized
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Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
671 Previous Clinical Trials
385,604 Total Patients Enrolled
2 Trials studying Amyloidosis
815 Patients Enrolled for Amyloidosis
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
284 Previous Clinical Trials
254,697 Total Patients Enrolled