This is a multi-centre, non-randomised trial of an antibody in patients with acute myeloid leukaemia (AML) or High Risk Myelodysplastic Syndrome (MDS).
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 or High Risk Myelodysplastic Syndrome. 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 (part A) will have the option of continuing treatment for a further 48 weeks in the first instance and may then be able to continue on treatment for longer (up to 52 weeks after the last patient is recruited), if treatment benefit is still being seen.
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;