1. Name of trial drug: KHK2823
  2. For what level of MDS severity risk: Low Risk or High Risk
  3. What subtype of MDS: All types - see specific inclusion criteria
  4. Aims and benefits: 
    This is a Phase 1 study that seeks to determine the effects of a new drug (KHK2823), the way in which it works and is managed in the body and its safety.

    - KHK2823 is an antibody that has the potential to kill cancer cells by blocking CD123, a molecule that is found on the cells in AML and MDS.

    - The study investigates this drug in a specific group of patients as outlined in the inclusion criteria below.

    - Primary outcome: To determine the safety and tolerability of the drug

    - Secondary outcome: To determine whether the disease (AML or MDS) responds to KHK2823 and whether the drug provokes an immune response in the body.

  5. Basic inclusion criteria:
    - previously untreated AML patients who are not candidates for intensive chemotherapy

    - relapsed/refractory AML patients for whom no other standard therapy is available or appropriate

    - relapsed/refractory MDS who have received prior therapy with a hypomethylating agent (such as decitabine and azacitidine) or who are not candidates to receive a hypomethylating agent

    - includes high risk or transfusion-dependent low risk MDS patients

    - ECOG performance status score of 0-2

    - Life expectancy of at least 3 months

  6. Basic exclusion criteria:
    - Histological diagnosis of acute promyelocytic leukemia (FAB Type M3)

    - Clinically significant central nervous system leukemia

    - Treatment of the AML or MDS with systemic therapy during the treatment period

  7. Trial sites/locations and name of physician in charge of trial: 
    Sites: University of Sussex, Royal Sussex County Hospital, Brighton;
    Beatson West of Scotland Cancer Centre, Glasgow;
    St James's Institute of Oncology, Leeds;
    NIHR/Wellcome UCLH Clinical Research Facility University College Hospital London, London;
    Northern Centre for Cancer Care, Freeman Road Hospital, Newcastle Upon Tyne;
    Southampton General Hospital, Southampton
  8. More information:

Please read information and always discuss trial information with your own physician.

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