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NCT04512235: Phase 3: To Evaluate Effectiveness & Safety of CAEL-101 in Stage IIIa AL Amyloidosis

Updated: Jul 2

CAEL-101 Amy

NCT04512235: Phase 3: A Study to Evaluate the Effectiveness and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis


CAEL-101

NCT04512235: Phase 3: A Study to Evaluate the Effectiveness and Safety of CAEL-101 in Patients With Mayo Stage IIIa 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 IIIa AL amyloidosis.


Sponsor

Caelum Biosciences, Inc.


Collaborator

Alexion Pharmaceuticals

 

ClinicalTrials.gov Identifier: NCT04512235

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 IIIa AL Amyloidosis

First Posted : August 13, 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, South Carolina

United States, Tennessee

United States, Texas

United States, Utah

United States, Washington

United States, Wisconsin

Canada, Alberta

Canada, Ontario

Australia

Europe

United Kingdom

Austria

Belgium

France

Germany

Greece

Italy

Poland

Spain

Asia

Israel

Japan

Korea, Republic of

Russian Federation

 

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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