- Name of trial drug: KHK2823
- For what level of MDS severity risk: Low Risk or High Risk
- What subtype of MDS: All types - see specific inclusion criteria
- Aims and benefits:
This is a Phase 1 study that seeks to determine the effects of a new drug (KHK2823), the way in which it works and is managed in the body and its safety.
- KHK2823 is an antibody that has the potential to kill cancer cells by blocking CD123, a molecule that is found on the cells in AML and MDS.
- The study investigates this drug in a specific group of patients as outlined in the inclusion criteria below.
- Primary outcome: To determine the safety and tolerability of the drug
- Secondary outcome: To determine whether the disease (AML or MDS) responds to KHK2823 and whether the drug provokes an immune response in the body.
- Basic inclusion criteria:
- previously untreated AML patients who are not candidates for intensive chemotherapy
- relapsed/refractory AML patients for whom no other standard therapy is available or appropriate
- relapsed/refractory MDS who have received prior therapy with a hypomethylating agent (such as decitabine and azacitidine) or who are not candidates to receive a hypomethylating agent
- includes high risk or transfusion-dependent low risk MDS patients
- ECOG performance status score of 0-2
- Life expectancy of at least 3 months
- Basic exclusion criteria:
- Histological diagnosis of acute promyelocytic leukemia (FAB Type M3)
- Clinically significant central nervous system leukemia
- Treatment of the AML or MDS with systemic therapy during the treatment period
- Trial sites/locations and name of physician in charge of trial:
Sites: University of Sussex, Royal Sussex County Hospital, Brighton;
Beatson West of Scotland Cancer Centre, Glasgow;
St James's Institute of Oncology, Leeds;
NIHR/Wellcome UCLH Clinical Research Facility University College Hospital London, London;
Northern Centre for Cancer Care, Freeman Road Hospital, Newcastle Upon Tyne;
Southampton General Hospital, Southampton
- More information:
Please read information and always discuss trial information with your own physician.