Study of REM-422 in Patients With AML or Higher Risk MDS
Trial Parameters
Brief Summary
The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with Higher Risk MDS and relapsed/refractory AML
Eligibility Criteria
Inclusion Criteria: 1. Be able to provide informed consent. 2. Be 18 or older at the time of informed consent. 3. Disease criteria: Histologically confirmed diagnosis of either: 1. R/R AML, defined as relapse after transplantation, second or later relapse, refractory to initial induction or reinduction treatment or to initial treatment with hypomethylating (HMA)-based combinations, relapse after initial treatment, or otherwise considered relapsed or refractory in the opinion of the Investigator. 2. High-risk and very-high-risk (VHR) MDS (higher-risk) per the International Prognostic Scoring System-Revised (IPSS-R) and/or International Prognostic Scoring System-Molecular (IPSS-M). 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Has agreed to undergo serial blood and bone marrow sampling. 6. Participants must have completed systemic non-investigational therapy at least 14 days prior to initiating REM-422. Hydroxyurea is permissible for controlling peripheral