NCT04504825: Phase 3: Efficacy & Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis
Updated: Feb 10
NCT04504825: Phase 3: A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis
NCT04504825: Phase 3: A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis
AL (or light chain) 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 whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival and it is safe and well tolerated in patients with stage IIIb AL amyloidosis.
Sponsor
Collaborator
AstraZeneca
ClinicalTrials.gov Identifier: NCT04504825
Official Title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL Amyloidosis
First Posted : August 7, 2020
Click here for details on ClinicalTrials.gov
Drug: CAEL-101
Other: Placebo
Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen
Anselamimab (Code C117241)
11-1F4
111F4
ANSELAMIMAB
Anselamimab
c11-1F4 mAb
CAEL 101
CAEL-101
CAEL101
Chimeric Amyloid-reactive Monoclonal Antibody CAEL-101
Chimeric Fibril-reactive Monoclonal Antibody CAEL-101
mAb-11-1F4
Locations
United States, Arizona
United States, California
United States, Florida
United States, Indiana
United States, Louisiana
United States, Maryland
United States, Massachusetts
United States, Michigan
United States, Minnesota
United States, Missouri
United States, New York
United States, North Carolina
United States, Ohio
United States, Oregon
United States, Pennsylvania
United States, Tennessee
United States, Texas
United States, Utah
United States, Washington
United States, Wisconsin
Canada, Alberta
Canada, Ontario
Australia
Europe
United Kingdom
Austria
Australia
Belgium
France
Germany
Netherlands
Poland
Switzerland
Spain
Greece
Israel
Italy
Asia
Japan
Russian Federation
Korea, Republic of
AstraZeneca to fully acquire Caelum Biosciences
29 September 2021
AstraZeneca will advance and accelerate ongoing Phase III clinical development of CAEL-101, a potential first-in-class medicine for AL amyloidosis