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