A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis
Study Identifier:
CAEL101-203
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: CAEL-101
- Drug: SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD)
- Drug: Daratumumab
Date
Mar 2020 - Nov 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A - N/A
Requirements Information
Sex
Female & Male
Age
N/A - N/A
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: CAEL-101
- Drug: SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD)
- Drug: Daratumumab
Date
Mar 2020 - Nov 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A - N/A years
Requirements Information
Protocol Summary
AL amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract.
The primary purpose of this study is to determine the recommended dose of CAEL-101 to facilitate progression of further clinical trials and evaluate safety and tolerability of CAEL-101 in combination with the standard of care (SoC) cyclophosphamide-bortezomib-dexamethasone (CyBorD) chemotherapy and daratumumab .
Trial Locations
Location
Status
Location
Research Site
Stanford, California, United States, 94305
Status
N/A
Location
Research Site
Detroit, Michigan, United States, 48201
Status
N/A
Location
Research Site
Cleveland, Ohio, United States, 44195
Status
N/A