NCT04304144View on ClinicalTrials.gov

A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

March 18, 2020

Primary Completion Date

November 14, 2023

Study Completion Date

November 14, 2023

Conditions
AL Amyloidosis
Interventions
DRUG

CAEL-101

The investigational product, CAEL-101, is formulated as a sterile liquid solution of protein plus excipients for dilution in a single-use, stoppered, glass vial. Each 10 mL vial contains 300 mg of CAEL-101 at a concentration of 30 mg/mL. CAEL-101 will be diluted with commercially available 0.9% Normal Saline.

DRUG

SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD)

According to institutional standard of care.

DRUG

Daratumumab

Treatment for AL amyloidosis

Trial Locations (3)

44195

Research Site, Cleveland

48201

Research Site, Detroit

94305

Research Site, Stanford

Sponsors
All Listed Sponsors
lead

Alexion Pharmaceuticals, Inc.

INDUSTRY