RecruitingMyelodysplastic SyndromesHigher Risk Myelodysplastic SyndromesAcute Myeloid Leukemia
Study of REM-422 in Patients With AML or Higher Risk MDS
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
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
Sponsor: Remix Therapeutics
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 1. Active central nervous system (CNS) leukemia or a confirmed diagnosis of CNS leukemia.
- ✕ 2. Has undergone hematopoietic stem cell transplantation (HSCT) within 60 days of the first dose of REM-422 or is receiving immunosuppressive therapy post HSCT at the time of screening, or has GVHD requiring systemic treatment (topical steroids for ongoing skin GVHD is permitted).
- ✕ 3. Has immediate, life-threatening, severe complications of leukemia, such as uncontrolled bleeding, pneumonia with hypoxia or sepsis, and/or disseminated intravascular coagulation.
- ✕ 4. Known hypersensitivity or contraindication to any component of REM-422 or to drugs chemically related to REM-422 or its excipients.
- ✕ 5. Clinically significant active infection. Note: Patients with simple urinary tract infection or uncomplicated bacterial pharyngitis responding to active treatment are permitted. Note: Patients receiving intravenous (IV) antibiotics ≤ 7 days prior to enrollment are excluded (prophylactic antibiotics, antivirals, or antifungals are permitted).
- ✕ 6. Evidence of active HIV infection.
- ✕ 7. Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- ✕ 8. Primary immunodeficiency.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06297941 · last updated 2025-04-23