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: 
    University of Sussex
    Royal Sussex County Hospital Brighton
    St James's Institute of Oncology Leeds
    NIHR/Wellcome UCLH Clinical Research Facility University College Hospital London
    St Bartholomew's Hospital 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.

Learn more about clinical trials

Check other current clinical trials

Free donations by shopping