Phase I study of KHK2823 in AML or MDS

• Research type

  Research Study

• Full title

  Phase I study of KHK2823 in Patients with Acute Myeloid Leukaemia or Myelodysplastic Syndrome

• IRAS ID

  151005

• Contact name

  Deborah Richardson

• Contact email

  Deborah.Richardson@uhs.nhs.uk

• Sponsor organisation

  Kyowa Hakko Kirin Pharma, Inc.

• Eudract number

  2013-003657-21

• ISRCTN Number

  N/A

• Research summary

  Acute Myeloid Leukaemia (AML) is a cancer of the myeloid line of blood cells characterised by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. Currently there is an unmet medical need to treat AML, particularly patients with relapsed (reappearance) or refractory (resistant) AML.
  Myelodysplastic syndrome (MDS) is a disorder of bone marrow that is characterised by ineffective production of the myeloid class of blood cells. There is a risk for participants who have MDS to progress to AML.
  The sponsor Kyowa Hakko Kirin Pharma, Inc has developed an antibody (protein which the immune system uses to recognise foreign material such as some cancer cells) called KHK2823 to be given to AML and MDS participants. Unlike some chemotherapy drugs for cancer, antibodies can target cancer cells more than the normal cells in the body. The target for KHK2823 is a protein which is found on cancer cells in AML and MDS.
  This study will test the safety, tolerability and potential effectiveness of the study drug KHK2823 on AML and MDS participants. There are two parts to this study. Part 1 will assess different dose levels of the study drug when given to 3-6 participants. Part 2 participants will receive a dose level which has been selected from part 1 for further testing.
  This is an ‘open label study’, which means that the doctors running the trial, as well as the participants, know the identity of drug being administered to each participant
  Up to 60 people in the UK who have AML or MDS will be invited to participate in this research study

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  14/YH/0088

• Date of REC Opinion

  30 Apr 2014

• REC opinion

  Further Information Favourable Opinion