Cookies on this website
We use cookies to ensure that we give you the best experience on our website. If you click 'Continue' we'll assume that you are happy to receive all cookies and you won't see this message again. Click 'Find out more' for information on how to change your cookie settings.

This is a multi-centre, non-randomised trial of an antibody in patients with acute myeloid leukaemia (AML).

Design: 

A multi-centre, non-randomized, Phase I, escalating dose titration cohort study of the CD47 blocking antibody Hu5F9-G4 in patients with relapsed or refractory acute myeloid leukaemia. The study has 2 parts: A dose titration schedule escalation phase (Part A) and a Maintenance phase (Part B).

Treatment: 

Hu5F9-G4; an anti-human CD47 monoclonal antibody will be administered intravenously once or twice a week.  The trial is of a dose escalation design. Patients who respond to the first 4 weeks of treatment will have the option of continuing treatment for a further 48 weeks i.e. up to 1 year in total.

Primary outcome measure:

  • Maximum tolerated dosing regimen of Hu5F9-G4;

Secondary outcome measures:

  • CD47 receptor occupancy;
  • Immunogenicity of Hu5F9-G4;
  • Impact of blood transfusion on Hu5F9-G4 pharmacokinetics;
  • Pharmacokinetic profile of Hu5F9-G4;
  • Preliminary evidence of anti-leukaemic/myelodysplastic activity of Hu5F9-G4;
  • Safety of extending treatment duration to 1 year;

Our team

  • Sarah Pearson

    OCTO Trial Management Director