A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS) (NCT05490446)

🧪 Interventions in This Study

• Tebapivat (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Phase 2a
2. At least 18 years of age at the time of providing informed consent;
3. Documented diagnosis of myelodysplastic syndromes (MDS) according to World Health Organization (WHO) classification (Arber et al, 2016), that meets Revised International Prognostic Scoring System (IPSS-R) classification of lower-risk disease (risk score: ≤3.5) and \<5% blasts as determined by the participant's bone marrow biopsy/aspirate during the Screening Period;
4. Nontransfused or with low transfusion burden (LTB), based on transfusion history from the participant's medical record, according to revised International Working Group (IWG) 2018 criteria:
5. Nontransfused (NTD): \<3 red blood cell (RBC) units in the 16-week period before administration of the first dose of study drug and no transfusions in the 8-week period before administration of the first dose of study drug, or
6. LTB: 3 to 7 RBC units in the 16-week period before administration of the first dose of study drug and \<4 RBC units in the 8-week period before administration of the first dose of study drug;
7. A hemoglobin (Hb) concentration \<11.0 grams per deciliter (g/dL) during the 4-week Screening Period;
8. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2;
9. If taking iron chelation therapy, the iron chelation therapy dose must have been stable and started ≥56 days before administration of the first dose of study drug;
10. Women of childbearing potential (WOCBP) must be abstinent of sexual activities that may result in pregnancy as part of their usual lifestyle or agree to use a highly effective method of contraception from the time of providing informed consent, throughout the study, and for 28 days after the last dose of study drug; if the highly effective method of contraception is hormonal contraception, then an acceptable barrier method must also be used. Men with partners who are WOCBP must be abstinent of sexual activities that may result in pregnancy as part of their usual lifestyle or agree to use a condom from the time of providing informed consent throughout the study and for 28 days after the last dose of study drug;
11. Written informed consent from the participant before any study-related procedures are conducted and willing to comply with all study procedures for the duration of the study. Phase 2b
12. At least 18 years of age at the time of providing informed consent;

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (45 Sites)

Showing the first 25 of 45 sites.

• Innovative Clinical Research Institute Whittier — Lakewood, California
• David Geffen School of Medicine at UCLA — Los Angeles, California
• Emad Ibrahim, MD, Inc. — Redlands, California
• Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut
• Mayo Clinic Jacksonville - PPDS — Jacksonville, Florida
• Edward H. Kaplan MD & Associates — Skokie, Illinois
• Washington University School of Medicine — St Louis, Missouri
• Memorial Sloan Kettering Cancer Center — Long Island City, New York
• Duke Adult Blood and Marrow Clinic — Durham, North Carolina
• Monash Health, Monash Medical Centre — Clayton, Victoria
• Ordensklinikum Linz GmbH Elisabethinen — Linz, Upper Austria
• Fakultni nemocnice Ostrava — Ostrava,
• Hôpital de La Conception — Marseille, Bouches-du-Rhône
• CHU Angers — Angers, Maine-et-Loire
• CHRU Lille — Lille,
• Hôpital Saint Louis — Paris,
• Medizinische Hochschule Hannover — Hanover, Lower Saxony
• Universitatsklinikum Dusseldorf — Düsseldorf, North Rhine-Westphalia
• Universitatsklinikum Leipzig — Leipzig, Saxony
• University Hospital of Alexandroupolis — Alexandroupoli,
• Attikon University General Hospital — Athens,
• University General Hospital of Patras — Pátrai,
• Hippokration Hospital — Thessaloniki,
• Shaare Zedek Medical Center — Jerusalem,
• Tel Aviv Sourasky Medical Center PPDS — Tel Aviv,

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Myelodysplastic Syndromes

• ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions — Clovis, California
• Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA — Tampa, Florida
• Ascorbate in Myelodysplastic Syndrome — Iowa City, Iowa
• A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) — Hot Springs, Arkansas
• Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes — Morgantown, West Virginia

Explore by condition: All Myelodysplastic Syndromes clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.