Plasma cell targeting using the anti-CD38 antibody daratumumab in patients with ME/CFS – a randomized, placebo-controlled and double-blind phase II study

Project description

The main purpose of this study is to investigate whether treatment with daratumumab has a clinically beneficial effect on symptoms in patients with moderate to severe ME/CFS compared with placebo, and to obtain further data on tolerance and side effects.

The investigators have previously conducted an initial pilot study in which 14 patients with moderate to severe ME/CFS received treatment with the drug daratumumab, an antibody that acts on the mature plasma cells of the immune system. The participants in the pilot study tolerated the drug well, and several patients experienced a significant improvement in their symptoms. The investigators are therefore conducting this new study, wherein they aim to compare the effect of daratumumab and placebo (injections with saline).

The total duration of the study for each participant is 72 weeks. Throughout the study, participants will be asked to regularly answer questionnaires, as well as to use a Fitbit watch to record their activity levels (number of steps per day and heart rate). Assessment, sampling and physical examinations are carried out in the Cancer Clinic at Haukeland University Hospital. Treatment is given at the Clinical Research Post at Haukeland, or at the Cancer Department’s outpatient clinic at Radium Hospital. Daratumumab will be administered as an injection under the skin of the abdomen three times at two-week intervals, and then twice after 24 and 26 weeks. Blood tests will be obtained prior and after each treatment administration, with any side effects being monitored for. The total duration of the study from inclusion to the last visit will be approximately 17 months.

Description adapted from project website: see link above.