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

Conditions

• Relapsed/Refractory Systemic Light Chain Amyloidosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Linvoseltamab — DRUG
  anti-B-cell maturation antigen x anti-Cluster of differentiation 3 bispecific antibody

Study Details

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)

Key Dates

Start date

Aug 7, 2024

Status verified

Apr 2026

Primary completion

Aug 20, 2028

Completion

Feb 20, 2035

Study Design

Enrollment

220 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

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

Primary Outcome Measure

Incidence of dose-limiting toxicity (DLTs) [ Time Frame: Up to 28 Days ]

Central Contacts

• Clinical Trials Administrator
  844-734-6643
  [email protected]

Locations (7)

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