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CAEL101-203: A Phase 2, Open-label, Multicenter Dose Selection Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis

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Trial Profile

CAEL101-203: A Phase 2, Open-label, Multicenter Dose Selection Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Mar 2025

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At a glance

  • Drugs Anselamimab (Primary) ; Bortezomib; Cyclophosphamide; Daratumumab; Dexamethasone
  • Indications Amyloid light-chain amyloidosis
  • Focus Adverse reactions
  • Sponsors Alexion AstraZeneca Rare Disease; Caelum Biosciences

Most Recent Events

  • 05 Mar 2025 Timeframe for primary endpoint 'Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation' was previously an average of 4 years. It has now been changed to 'from the first dose of the study drug until 140 days after the last dose of the study drug.
  • 12 Dec 2023 Results (n=25 )assessing safety, tolerability, and biomarker data after 110 weeks of treatment with CAEL-101, administered initially with cyclophosphamide-bortezomib-dexamethasone and daratumumab, were presented at the 65th American Society of Hematology Annual Meeting and Exposition.
  • 29 Nov 2023 According to an AstraZeneca media release, 24-month results from this study will be presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA, 9 to 12 December 2023.

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