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Study of REM-422 in Patients With AML or Higher Risk MDS | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06297941•Remix Therapeutics

View on ClinicalTrials.gov

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

Detailed Description

This is a Phase 1, open-label, non-randomized, multicenter study investigating REM-422, a potent, selective, and oral small molecule mRNA degrader that reduces expression of the MYB transcription factor for patients with higher risk MDS or relapsed/refractory AML. This study includes a Dose Escalation Phase and a Dose Expansion Phase. The purpose of the Dose Escalation Phase is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of REM-422 in patients with higher risk MDS or relapsed/refractory AML. The purpose of Dose Expansion is to further evaluate the safety and anti-tumor activity of the RP2D carried forward from Dose Escalation. Participation in this study will continue until disease progression, therapy intolerance, or participant withdrawal.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 leukemic blasts prior to enrollment and for up to 28 days following initiation of REM-422.
•7. Toxicities from prior therapy must be either stable or recovered to ≤ Grade 1.
+6 more criteria

Exclusion Criteria

•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.
•9. Current or expected need for daily systemic corticosteroid therapy ≥ 10 mg of prednisone equivalent.
•Note: Patients who are receiving topical or inhaled corticosteroids with minimal systemic absorption are eligible for enrollment and may continue with minimal corticosteroid use as long as they are on a stable dose.
+15 more criteria

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

Key Dates

Start Date

April 26, 2024

Primary Completion Date

March 15, 2026

Completion Date

June 15, 2027

Last Updated

April 23, 2025

Enrollment

100

ESTIMATED participants

Conditions

Myelodysplastic SyndromesHigher Risk Myelodysplastic SyndromesAcute Myeloid LeukemiaAcute Myeloid Leukemia Refractory

Interventions

REM-422

DRUG

Contacts

Remix Therapeutics

CONTACT

781-827-0902 ClinicalTrials@remixtx.com

Rosalie Jiang

CONTACT

781-584-9390 rjiang@remixtx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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