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

Официальное название

A Phase 1/2 Study of Linvoseltamab in Patients With Relapsed or Refractory Systemic Light Chain Amyloidosis

Обзор

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)

Вмешательства

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

Первичные конечные точки

• Incidence of dose-limiting toxicity (DLTs) [Срок оценки: Up to 28 Days]
• Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC) [Срок оценки: Up to 3 years]

Вторичные конечные точки (12)

• Achievement of hematologic CR, as determined by the IRC [Срок оценки: Up to 3 years]
• Achievement of hematologic very good partial response (VGPR) or better response (CR + VGPR), as determined by the IRC [Срок оценки: Up to 3 years]
• Achievement of overall hematologic response (PR or better), as determined by the IRC [Срок оценки: Up to 3 years]
• Time to initial hematologic response [Срок оценки: Up to 3 years]
• Time to best hematologic response [Срок оценки: Up to 3 years]
• Duration of hematologic response (ie, best response, VGPR or better, overall response), as determined by the IRC [Срок оценки: Up to 7 years]
• Hematologic progression-free survival (PFS) [Срок оценки: Up to 7 years]
• Incidence of death [Срок оценки: Up to 7 years]
• Incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: Up to 39 months]
• Severity of TEAEs [Срок оценки: Up to 39 months]
• Incidence of serious adverse events (SAEs) [Срок оценки: Up to 39 months]
• Severity of SAEs [Срок оценки: Up to 39 months]

Критерии участия

Критерии включения

• Confirmed diagnosis of AL amyloidosis, as described in the protocol
• Measurable disease as defined by serum difference between involved and uninvolved free light chains (dFLC) concentration, as described in the protocol
• Previously treated after at least 1 prior therapy and requiring further treatment as assessed by the Investigator
• N-terminal pro b-type natriuretic peptide (NT-proBNP) ≤8500 ng/L during screening
• Adequate hepatic, hematologic, renal, and cardiac function, as described in the protocol
• Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening

Критерии исключения

• History of other non-AL amyloidosis
• Greater than 60% plasmacytosis on a bone marrow biopsy and/or aspirate during screening
• Presence of lytic bone lesion(s) or extramedullary plasmacytoma on imaging during screening
• Myocardial infarction within the past 6 months prior to the first screening visit
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 8 центров

• City of Hope — Duarte
• Colorado Blood Cancer Institute/SCRI — Denver
• Boston Medical Center — Boston
• Karmanos Cancer Institute — Detroit
• Roswell Park Comprehensive Cancer Center — Buffalo
• Ohio State University — Columbus
• SCRI Oncology Partners — Nashville
• MD Anderson Cancer Center — Houston

Испания · 5 центров

• Hospital Universitari Son Espases — Palma
• Clinica Universidad de Navarra - Pamplona — Pamplona
• Hospital de Cabuenes — Gijón
• Universität de Barcelona- Institut d' Investigacions Biomediques August Pi i Sunyer (IDIBA — Barcelona
• University Hospital La Fe — Valencia

South Korea · 4 центра

• Seoul National University Hospital — Seoul
• Asan Medical Center — Seoul
• Samsung Medical Center — Seoul
• Seoul St. Mary's Hospital - The Catholic University of Korea — Seoul

Великобритания · 2 центра

• University College London Hospitals — London
• The Christie NHS Foundation Trust — Manchester

Греция · 1 центр

• National and Kapodistrian University of Athens — Athens

Идентификаторы

NCT: NCT06292780 · R5458-ONC-2274 · 2023-507809-34-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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