The randomized, double-blind, placebo-controlled Phase 3 trial of Descartes 08 in patients with Myasthenia gravis

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 31 Jan 2025

Price :

Note:

Adis is an information provider.
Final gross price and currency may vary according to local VAT and billing address.
Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
A link to download a PDF version of the trial profile will be included in your email receipt.

27 Jan 2025 According to a Cartesian Therapeutics media release,company announced it has received written agreement from the US Food and Drug Administration under the Special Protocol Assessment process on the overall design of the Company's planned Phase 3 AURORA trial for Descartes-08 in myasthenia gravis. The SPA agreement indicates that the FDA has determined that the proposed trial design is acceptable to support a future BLA for Descartes-08 in MG, subject to the ultimate outcome of the trial.
10 Dec 2024 New trial record
03 Dec 2024 According to Cartesian Therapeutics media release, the company expects to commence the trial in the first half of 2025.

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com