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New treatment option for Myelodysplastic Syndromes
Official title Study of REM-422 in Patients With AML or Higher Risk MDS
ClinicalTrials.gov ID: NCT06297941
What this study is testing
What is REM-422?
REM-422 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for myelodysplastic syndromes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be able to provide informed consent.
- Be 18 or older at the time of informed consent.
- Disease criteria: Histologically confirmed diagnosis of either:
- R/R AML, defined as relapse after transplantation, second or later relapse, refractory to initial induction or reinduction treatment or to initial...
- High-risk and very-high-risk (VHR) MDS (higher-risk) per the International Prognostic Scoring System-Revised (IPSS-R) and/or International Prognostic...
You likely can't join if
- Active central nervous system (CNS) leukemia or a confirmed diagnosis of CNS leukemia.
- Has undergone hematopoietic stem cell transplantation (HSCT) within 60 days of the first dose of REM-422 or is receiving immunosuppressive therapy...
- Has immediate, life-threatening, severe complications of leukemia, such as uncontrolled bleeding, pneumonia with hypoxia or sepsis, and/or...
- Known hypersensitivity or contraindication to any component of REM-422 or to drugs chemically related to REM-422 or its excipients.
- Clinically significant active infection. Note: Patients with simple urinary tract infection or uncomplicated bacterial pharyngitis responding to...
- Evidence of active HIV infection.
See the full eligibility criteria
- Be able to provide informed consent.
- Be 18 or older at the time of informed consent.
- Disease criteria: Histologically confirmed diagnosis of either:
- 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...
- 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).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has agreed to undergo serial blood and bone marrow sampling.
- 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...
- Toxicities from prior therapy must be either stable or recovered to ≤ Grade 1.
- Participants must be able to swallow and retain oral medications.
- Oxygen saturation \> 92% on room air or up to 2 L/min supplemental oxygen by nasal cannula with ≤ Grade 1 dyspnea.
- People of childbearing potential (POCBP) must have a negative serum beta-human chorionic gonadotropin test result.
- POCBP must agree to use acceptable, effective methods of contraception and not donate ova from screening until 6 months after discontinuation of REM-422. Women who have undergone surgical or ablative sterilization or...
- Men must agree to use acceptable, effective methods of contraception and must agree not to donate sperm from the start of receiving REM-422 until 6 months after discontinuation of REM-422.
- Adequate organ function and laboratory parameters
- Active central nervous system (CNS) leukemia or a confirmed diagnosis of CNS leukemia.
- 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...
- Has immediate, life-threatening, severe complications of leukemia, such as uncontrolled bleeding, pneumonia with hypoxia or sepsis, and/or disseminated intravascular coagulation.
- Known hypersensitivity or contraindication to any component of REM-422 or to drugs chemically related to REM-422 or its excipients.
- 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)...
- Evidence of active HIV infection.
- Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Primary immunodeficiency.
- 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...
- Live vaccine ≤ 6 weeks prior to the start of REM-422.
- Use of strong CYP3A inhibitors (except azole antifungals) or CYP3A inducers
- Drugs that reduce gastric acidity, such as H2-receptor antagonists (eg, ranitidine, famotidine) and proton pump inhibitors (eg, omeprazole, esomeprazole) within 7 days prior to the initiation of REM-422 administration...
- Currently pregnant, have intentions to become pregnant during the study duration, or are currently lactating.
- Has dysphagia, short-gut syndrome, gastroparesis, or any other condition that limits the ingestion or gastrointestinal absorption of orally administered drugs.
- Current use of prohibited medication ≤ 1 week before starting REM-422.
- Clinically significant cardiovascular disease:
- Has undergone major surgery (opening a mesenchymal barrier such as the pleural cavity, peritoneum, or meninges or surgical procedures requiring general anesthesia) \< 4 weeks prior to enrollment.
- History of organ transplant that requires use of immunosuppressive agents.
- History or current autoimmune disease requiring systemic treatment (eg, Crohn's disease, ulcerative colitis, rheumatoid arthritis, systemic lupus).
- Radiation therapy ≤ 7 days prior to the start of REM-422.
- Concurrent or previous other malignancy ≤ 2 years of enrollment, except curatively treated malignancies including basal or squamous cell skin cancer, breast cancer, prostate intraepithelial neoplasm, and carcinoma in...
- Receiving any other investigational treatment for any indication ≤ 3 weeks prior to enrollment.
- Unwillingness or inability to follow protocol requirements.
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of REM-422 or interpretation of the participant's safety or study results.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Houston, Texas, United States
- Bordeaux, France
- Paris, France
- Toulouse, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Tampa, Florida, United States; Boston, Massachusetts, United States; New York, New York, United States; Houston, Texas, United States; Bordeaux, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.