• Recruiting

NCT04504825: Phase 3: Efficacy & 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

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

Alexion Pharmaceuticals


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

 

CAEL 101

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

Click here for details





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