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 MDS Alliance.
Introducing
Now you can personalise
your MDS Hub experience!
Bookmark content to read later
Select your specific areas of interest
View content recommended for you
Find out moreThe MDS 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 MDS Hub cannot guarantee the accuracy of translated content. The MDS 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.
On September 27, 2023, it was announced that the first two patients had been dosed in the multicenter, open-lab, dose-escalation, phase I/II ReSET-02 trial (NCT05768035).1
This trial will assess the safety and efficacy of SMART101, an allogeneic cell therapy produced from donor-mobilized peripheral blood stem cells differentiated into T-cell progenitors, in adult patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndromes (MDS) who are eligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT) with a haploidentical donor with post-transplant cyclophosphamide.1
SMART101 has previously been granted orphan drug designation by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), and fast-track designation by the FDA, for the treatment of patients undergoing allo-HSCT.1
In total, 40 patients are planned to be enrolled in the trial, with the phase II portion consisting of two parallel cohorts according to the intensity of conditioning chemotherapy.1 Preliminary data suggest that SMART101 is well tolerated, with the safety profile as expected.1
Subscribe to get the best content related to MDS delivered to your inbox