A pilot study using subcutaneous injections of the anti-CD38 antibody daratumumab in six patients with moderate to severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Resetting the humoral immune response in ME/CFS.

Haukeland University Hospital, Dept. of Oncology and Medical Physics0 个研究点目标入组 10 人开始时间: 2022年2月7日最近更新: 2024年8月26日

适应症

试验速览

暂无简介。

•ME/CFS according to Canadian consensus criteria (2003) (1);moderate (mainly housebound) to severe (mainly bedridden) disease.
•Age 18 to 65 years.
•Signed informed consent.
•Duration of ME/CFS disease at least two years.
•The ME/CFS disease should have a defined onset, e.g. after an initial infection or other immunological trigger.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Chronic fatigue conditions not fulfilling Canadian consensus criteria.
•Age under 18 or over 65 years.
•Mild or mild-to moderate ME/CFS.
•Very severe ME/CFS, where patient is unable to travel to the hospital for intervention and assessments.
•Participation in a clinical trial with intervention aimed at ME/CFS during the last two years.
•Endogenous depression.
•Known multi-allergy with clinically assessed risk for hypersensitivity to daratumumab.
•Known contraindication to daratumumab.
•Significant comorbidity with reduced organ function (kidney, liver, heart, pulmonary).
•Previous long-term systemic treatment with immunosuppressants the last two years, excluding short steroid courses in e.g. obstructive lung disease.
•Chronic infections, including chronic hepatitis B or C, HIV, or other relevant infection.
•Previous or concomitant malignant disease, except basal carcinoma of the skin, or carcinoma in situ in the uterine cervix.
•Pregnancy or lactation.
•Inability to comply with protocol including follow-up.

发起方

Haukeland University Hospital, Dept. of Oncology and Medical Physics