RecruitingLow Risk Myelodysplastic Syndromes

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

Eligible age

18+ yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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Phase 1b Study of R289 in Patients with Lower-risk Myelodysplastic Syndromes (LR MDS)

Sponsor: Rigel Pharmaceuticals

✓ 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:
✓ a. Must meet at least one of the following criteria prior to initial administration of study treatment: 1) Symptomatic anemia with hemoglobin \< 9.0 g/dL and no RBC transfusion within 16 of registration or 2) RBC transfusion dependent defined as receiving ≥ 2 units of packed red blood cells (PRBCs) within 8 weeks in the preceding 16 weeks for a hemoglobin \<9.0 g/dL.
✓ DOSE EXPANSION PHASE:
✓ 1. Relapsed, refractory to or ineligible for ESAs and has previously received one or more approved therapies for LR-MDS
✓ 2. Must be RBC transfusion dependent defined as receiving ≥ 2 units of packed red blood cells (PRBCs) within 8 weeks in the preceding 16 weeks for a hemoglobin \<9.0 g/dL.

✕ 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:
✕ 1. Adequately treated in situ carcinoma of the cervix uteri

Los Angeles · Orange · Palo Alto

Miami · Miami Beach

St Louis

Hackensack · New Brunswick

Durham

Cleveland · Columbus

Dallas · Houston

Salt Lake City

Source: ClinicalTrials.gov · NCT05308264 · last updated 2026-08-10