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Study of R289 for Lower-risk Myelodysplastic Syndromes

This study is testing a drug called R289 Monosodium (R289 Na) for people with lower-risk Myelodysplastic Syndromes (MDS). MDS is a group of conditions where your bone marrow doesn't make enough healthy blood cells. This study is for adults aged 18 or older who have lower-risk MDS and whose previous treatments, like erythropoietin (EPO), luspatercept, or hypomethylating agents (HMAs), haven't worked well or they couldn't tolerate them. The main goal is to see how safe R289 Monosodium is and if people can tolerate it over two years. The study also aims to see if the drug shows early signs of helping patients.

Study design
This is an open-label, Phase 1b study, meaning both you and the study team will know which treatment you are receiving. It plans to enroll 86 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The safety and tolerability of the drug will be measured for up to two years.

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NCT05308264

Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Rigel Pharmaceuticals
~86 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:R906289 Monosodium (R289 Na)

At a glance

Recruiting sites
13 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability
Measured over 2 Year

Conditions

Low Risk Myelodysplastic Syndromes

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Where it's being run

15 sites across 9 states
California3
Florida2
New Jersey2
Ohio2
Texas2
Missouri1
New York1
North Carolina1

Who to contact

Strait Hicklin
[email protected]
(650) 624-1100
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient must be ≥ 18 years of age at the time of signing the informed consent.
Must have definitive diagnosis of MDS with very low, low, or intermediate-1 risk (International Prognostic Scoring System (IPSS)-R ≤ 3.5) and ≤5% bone marrow myeloblasts.
Must be relapsed, refractory/resistant, intolerant, or have inadequate response to therapies with known clinical benefits for MDS, such as EPOs, luspatercept, and HMAs(i.e., azacytidine or decitabine). Patients with del (5q) must have failed prior lenalidomide therapy.
DOSE ESCALATION PHASE:
DOSE EXPANSION PHASE:
EXPLORATORY PHASE 1b COHORT:
All patients must have documented marrow iron stores. If marrow iron stain is not available, the transferrin saturation must be \>20% or a serum ferritin \> 100ng/100mL
Must have Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 at screening.
Must have adequate organ function, defined as:
aspartate amino transferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 × upper limit of normal (ULN)
total bilirubin ≤ 1.5 × ULN 2. Renal function defined as creatinine clearance \> 60 mL/min (using Cockcroft-Gault), or blood creatine \< 1.5 mg/dL

Exclusion

Prior treatment for MDS (i.e., TPOs, EPOs, luspatercept, HMAs) concluded \< 4 weeks prior to study treatment
Clinically significant anemia resulting from iron, B12 or folate deficiencies, autoimmune or hereditary hemolysis, or GI bleeding.
MDS secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or autoimmune diseases.
Diagnosis of chronic myelomonocytic leukemia.
History of uncontrolled seizures.
Uncontrolled bacterial or viral infection (i.e., documented HIV, hepatitis B or hepatitis C).
History of other malignancy that could affect compliance or interpretation of results. Patients with an malignancy other than leukemia appropriately treated with curative intent and the malignancy has been in remission without treatment for ≥ 2 years prior to study entry are eligible as are:
History of or active, clinically significant, cardiovascular, respiratory, GI, renal, hepatic, neurological, psychiatric, musculoskeletal, genitourinary, dermatological, or other disorder that, in the Investigator's opinion (or following review by the Sponsor), could affect the conduct of the study or the absorption, metabolism or excretion of the study treatment.
Prior history of autologous or allogeneic stem cell transplantation
Marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \> 480 milliseconds \[msec\]) (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 1) using Fridericia's QT correction formula.
History of additional risk factors for TdP (e.g., symptomatic heart failure with left ventricular ejection fraction \[LVEF\] \<40%, hypokalemia, family history of Long QT Syndrome).
Receiving any other concurrent chemotherapy, radiotherapy, or immunotherapy (within 2 weeks of initiating study treatment), or the toxicity of the relevant prior treatment has not been resolved yet. For any long-acting systemic agent such as a monoclonal antibody, study treatment should not begin within two half-lives of the agent.
Use of concomitant medications that prolong the QT/QTc interval during study treatment
Use of concomitant medications that are strong CYP3A or CYP2B6 inhibitors or inducers during study treatment

What this trial measures

  • Safety and Tolerability2 Year

    * Incidence of adverse events (AEs) * Incidence of discontinuation or interruptions of R289 due to AEs * Incidence of dose limiting toxicities (DLTs)