Actively Recruiting
Study of REM-422 in Patients With AML or Higher Risk MDS
Led by Remix Therapeutics · Updated on 2025-04-23
100
Participants Needed
9
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study of REM-422 in Patients With AML or Higher Risk MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent
- 18 years of age or older at the time of consent
- Histologically confirmed relapsed or refractory AML or high-risk/very-high-risk MDS per IPSS-R or IPSS-M
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Agreed to undergo serial blood and bone marrow sampling
- Completed systemic non-investigational therapy at least 14 days before starting REM-422; hydroxyurea is allowed for controlling leukemic blasts prior to and up to 28 days after starting REM-422
- Toxicities from prior therapy stable or recovered to Grade 1 or less
- Able to swallow and retain oral medications
- Oxygen saturation above 92% on room air or up to 2 L/min supplemental oxygen with Grade 1 or less dyspnea
- Negative serum beta-human chorionic gonadotropin test for people of childbearing potential
- People of childbearing potential agree to use effective contraception and not donate ova during and for 6 months after REM-422 treatment; postmenopausal or surgically sterilized women are exempt
- Men agree to use effective contraception and not donate sperm during and for 6 months after REM-422 treatment
- Adequate organ function and laboratory parameters
You will not qualify if you...
- Active central nervous system (CNS) leukemia
- Hematopoietic stem cell transplantation (HSCT) within 60 days before first REM-422 dose or ongoing immunosuppressive therapy post-HSCT; graft versus host disease (GVHD) requiring systemic treatment (topical steroids for skin GVHD allowed)
- Life-threatening severe leukemia complications such as uncontrolled bleeding, pneumonia with hypoxia, sepsis, or disseminated intravascular coagulation
- Known allergy or contraindication to REM-422 or related drugs
- Active clinically significant infection, except treated simple urinary tract infection or bacterial pharyngitis; intravenous antibiotics within 7 days before enrollment excluded
- Active HIV, hepatitis B, or hepatitis C infection
- Primary immunodeficiency
- Current or expected need for systemic corticosteroids equivalent to 10 mg or more prednisone daily (stable low-dose inhaled or topical corticosteroids allowed)
- Live vaccine within 6 weeks before REM-422 start
- Use of strong CYP3A inhibitors (except azole antifungals) or inducers
- Use of drugs reducing gastric acidity (H2 blockers or proton pump inhibitors) within 7 days before or during study
- Pregnant, intending to become pregnant, or currently lactating
- Conditions limiting oral drug ingestion or absorption such as dysphagia, short-gut syndrome, or gastroparesis
- Use of prohibited medications within 1 week before REM-422 start
- Significant cardiovascular disease
- Major surgery within 4 weeks before enrollment
- History of organ transplant requiring immunosuppression
- Autoimmune disease needing systemic treatment
- Radiation therapy within 7 days before REM-422 start
- Other malignancy within 2 years except certain treated cancers
- Receiving other investigational treatments within 3 weeks before enrollment
- Unable or unwilling to follow study protocol
- Any condition interfering with evaluation or safety assessment of REM-422 as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Memorial Sloan Kettering
New York, New York, United States, 10065
Actively Recruiting
5
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
6
Centre Hospitalier Universitaire (CHU) de Bordeaux
Bordeaux, France
Actively Recruiting
7
AP-HP - Hôpital Saint-Louis
Paris, France
Actively Recruiting
8
IUCT-Oncopole
Toulouse, France
Actively Recruiting
9
Institut de Cancerologie Gustave-Roussy
Villejuif, France
Actively Recruiting
Research Team
R
Remix Therapeutics
CONTACT
R
Rosalie Jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here