Open-Label Extension of EryDex in A-T (OLE NEAT)
Research type
Research Study
Full title
An Open-Label Extension Study of EryDex in Patients with Ataxia Telangiectasia Following Participation in Study IEDAT-04-2022 (NEAT)
IRAS ID
1010413
Contact name
Katie George
Contact email
Sponsor organisation
Quince Therapeutics S.p.A.
Eudract number
2024-513618-37
Research summary
The purpose of this study is to collect information on the safety and tolerability of the trial treatment. Study drug will be placed into the red blood cells using the EryDex System. About 50 mL of blood will be collected. After study drug is placed into the red blood cells using the EryDex System, the red blood cells will then be put back into the body through a vein in the arm (infusion).
Approximately 106 participants from IEDAT-04-2022 will take part in this study. The study is being done in various regions
including North America, Europe, and United Kingdom.
This study treatment period lasts approximately 14 months and will consist of 12 infusions (one infusion approximately every 28 days).
This is an open-label study, which means that participants will receive the study drug.
The study drug is dexamethasone sodium phosphate (DSP), encapsulated in the red blood cells, by means of a procedure called
EryDex System. The treatment is called “EryDex”.
During this EryDex process, 50 mL of blood will be collected before each treatment and the subsequent infusion will be a total
volume of approximately 70-80 mL (includes blood, study drug and solutions used to conduct the EryDex System Process).REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
24/YH/0235
Date of REC Opinion
23 Dec 2024
REC opinion
Further Information Favourable Opinion