All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.
The Lymphoma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy
Introducing
Now you can personalise
your Lymphoma Hub experience!
Bookmark content to read later
Select your specific areas of interest
View content recommended for you
Find out moreThe Lymphoma Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the Lymphoma Hub cannot guarantee the accuracy of translated content. The Lymphoma Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The Lymphoma & CLL Hub is an independent medical education platform, sponsored by Beigene, Johnson & Johnson and Roche, and supported through educational grants from Bristol Myers Squibb, Incyte, Ipsen Biopharmaceuticals, Lilly, and Pfizer. View funders.
Orphan drug designation granted to MB-105 for the treatment of R/R T-cell lymphoma
Bookmark this article
On January 29, 2025, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to MB-105, a first-in-class autologous CD5-targeted CAR T-cell therapy, for the treatment of relapsed/refractory (R/R) T-cell lymphoma.1
This announcement is based on key results from a phase I MB-105 (NCT03081910) trial, which demonstrated favorable safety/tolerability and promising clinical efficacy of MB-105 in patients with R/R T-cell lymphoma (N = 17), with an overall response rate of 44%.1,2
- GlobeNewswire. March Biosciences receives FDA orphan drug designation for MB-105, a first-in-class CD5 CAR-T cell therapy, for T-cell lymphoma. https://www.globenewswire.com/news-release/2025/01/28/3016342/0/en/March-Biosciences-Receives-FDA-Orphan-Drug-Designation-for-MB-105-a-First-in-Class-CD5-CAR-T-Cell-Therapy-for-T-Cell-Lymphoma.html Published Jan 29, 2025. Accessed Jan 29, 2025.
- LaQuisa C, Rayne H, Mengfen WJ, et al. Antitumor efficacy and safety of unedited autologous CD5.CAR T cells in relapsed/refractory mature T-cell lymphomas. Blood. 2024;143(13):1231-1241. DOI: 10.1182/blood.2023022204
Understanding your specialty helps us to deliver the most relevant and engaging content.
Please spare a moment to share yours.
Please select or type your specialty
Thank youYour opinion matters
83 votes - 73 days left ...
Related articles
Newsletter
Subscribe to get the best content related to lymphoma & CLL delivered to your inbox