RecruitingPhase 1NCT06297941

Study of REM-422 in Patients With AML or Higher Risk MDS

A Phase 1, Multicenter, Open-Label Study of REM-422, an MYB mRNA Degrader, in Patients With Relapsed/Refractory AML or Higher-Risk MDS


Sponsor

Remix Therapeutics

Enrollment

100 participants

Start Date

Apr 26, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral drug called REM-422 in adults with relapsed or treatment-resistant acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) — blood cancers where the bone marrow produces abnormal cells. **You may be eligible if...** - You are 18 or older with confirmed AML that has relapsed or has not responded to prior treatment, including treatment after stem cell transplant - OR you have high-risk or very-high-risk MDS per standard risk scoring systems - You have good performance status (ECOG 0–1) and key organ functions within acceptable range - You finished prior therapy at least 14 days before starting this study drug - You are willing to have blood and bone marrow samples collected during the study **You may NOT be eligible if...** - You have significant untreated side effects from prior therapy - You are on oxygen beyond minor supplemental needs - You are pregnant or not willing to use contraception - You cannot swallow tablets Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGREM-422

REM-422 is a first in class, small molecule mRNA inhibitor that reduces expression of the MYB transcription factor REM-422 will be administered orally once daily


Locations(9)

City of Hope

Duarte, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Memorial Sloan Kettering

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

Centre Hospitalier Universitaire (CHU) de Bordeaux

Bordeaux, France

AP-HP - Hôpital Saint-Louis

Paris, France

IUCT-Oncopole

Toulouse, France

Institut de Cancerologie Gustave-Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

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NCT06297941


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