A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis) (LINKER-AL2)
NCT06292780
Age 18 +
Sex Both
Phase Phase 1, Phase 2
Third Opinion Trial Synopsis
In this clinical study, researchers are exploring a new treatment approach for patients with a specific type of blood cancer. The study focuses on a combination of therapies that aim to improve patient outcomes and provide more effective options for managing the disease. Here are some key details about the study:
- The study investigates the use of a unique combination of therapies that have not been widely tested together before.
- It includes patients who have previously received treatment, allowing researchers to assess the effectiveness of the new approach in those who may have limited options left.
- Participants will be monitored closely to evaluate how well the treatment works and to identify any potential side effects.
- The study aims to gather data on the safety and effectiveness of the treatment, which could lead to new standards of care for patients.
- By focusing on a specific patient population, the study hopes to provide insights that could benefit others with similar conditions.
Third Opinion AI Generated Synopsis
Trial Summary
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)
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)
from ClinicalTrials.gov
Locations & Contact
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