AURORA
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Descartes-08 in Patients with Generalized Myasthenia Gravis (MG)
IRAS ID
1011693
Contact name
Eva Rybank
Contact email
Sponsor organisation
Cartesian Therapeutics, Inc.
Eudract number
2024-520355-25
Clinicaltrials.gov Identifier
Research summary
Autoimmune myasthenia gravis (MG) is a condition where the body's immune system mistakenly attacks parts of the nerves and muscles, making it hard for them to work together properly. This can cause muscle weakness and tiredness.
Current treatments for MG try to help the nerves and muscles communicate better or calm down the immune system. Some medicines, like pyridostigmine, can help with symptoms, but they don't fix the main problem of the immune system attacking the body.
This study is testing a new medicine called Descartes-08. The main goal is to see if it can help people with MG do their daily activities better. They'll measure this using a special test called the MG Activities of Daily Living scale after 4 months of treatment.
The study has two parts:
1. In the first part, some people will get Descartes-08 and others will get a fake medicine (placebo) once a week for six weeks. This helps the researchers compare how well Descartes-08 works compared to no treatment.
2. In the second part, if you got Descartes-08 in the first part and still qualify, you might get more doses. If you don't qualify for more treatment, you'll still have follow-up visits with the doctors.This study is trying to find out if Descartes-08 can be a better treatment for people with MG by addressing the root cause of the disease.
8 countries will participate in the study, with expected 100 patients to be enrolled across 41 sites.
Cartesian Therapeutics, is the Sponsor of the study.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
25/LO/0326
Date of REC Opinion
17 Jun 2025
REC opinion
Further Information Favourable Opinion