CAMELLIA: Anti-CD47 antibody therapy in relapsed/refractory AML
Research type
Research Study
Full title
A Phase I dose escalation trial of the Humanized Anti-CD47 Monoclonal Antibody Hu5F9-G4 in Acute Myeloid Leukaemia
IRAS ID
177680
Contact name
Paresh Vyas
Contact email
Sponsor organisation
Stanford University
Eudract number
2015-000720-29
Duration of Study in the UK
1 years, 9 months, 30 days
Research summary
The aim of this study is to determine whether a new drug, called Hu5F9-G4, is a safe and well tolerated treatment for patients with Acute Myeloid Leukaemia (AML), whose disease has either not responded to standard treatments or has relapsed following an initial response. There is an urgent need for new treatments for these patients, who currently only receive supportive care and have a median survival of only 2 months.
Laboratory research has shown that leukaemia cells have a molecule on their surface called CD47. This molecule tells the immune system not to destroy the leukaemia cell. Hu5F9-G4 is a new type of drug which binds to CD47 so that it is blocked and the leukaemia cells can therefore be destroyed by the immune system. Results from using the drug in animal models of AML have been promising, but this will be the first time the drug has been given to humans with AML.
The trial will be conducted at 8 UK hospitals specialising in the treatment of AML. Between 7 and 30 patients will be recruited to the trial, which is of a 'dose escalation' design whereby patients will be entered at different dose levels- beginning with the lowest dose and escalating to higher doses only if results from the previous patients treated show it is safe to do so.
After completion of screening assessments patients will receive 4 weeks of treatment with Hu5F9-G4, given as an intravenous infusion. Patients will be closely monitored for any signs of toxicity and to assess whether Hu5F9-G4 is effective in treating AML. Patients who respond to the first 4 weeks of treatment will have the option of continuing treatment for a further 8 weeks (12 weeks in total).
REC name
South Central - Oxford C Research Ethics Committee
REC reference
15/SC/0215
Date of REC Opinion
29 Apr 2015
REC opinion
Favourable Opinion