Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07388602
Eligibility Criteria:
Inclusion Criteria:
* Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red stained tissue specimens or characteristic electron microscopy appearance;
* Measurable disease of amyloid light-chain (AL) amyloidosis;
* One or more organs impacted by AL amyloidosis according to consensus guidelines
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
Exclusion Criteria:
* Prior therapy for AL amyloidosis;
* Other amyloidosis;
* Uncontrolled infection.
* Subjects with conditions that may affect safety or efficacy assessments include, but are not limited to, cardiovascular, respiratory, endocrine/metabolic, immune system, hepatic, gastrointestinal (such as gastrointestinal bleeding, perforation, ulcers, etc.), and malignant neoplasms, and are deemed clinically significant by the investigator.
* Subjects who have undergone major surgery or experienced significant trauma within 4 weeks prior to the first use of the investigational drug, or who require elective surgery during the trial period.
* Received a live or attenuated vaccine within 30 days prior to the first dose; Female subjects who are currently breastfeeding.
* Subjects with mental disorders or poor compliance, or other circumstances deemed unsuitable for participation in this study by other investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07388602
Study Brief:
Protocol Section:
NCT07388602