Treatment with daratumumab injections in moderate to severe ME/CFS

About

Status:

Completed

Principal investigator:

Øystein Fluge, Olav Mella

Country:

Norway

Study start:

2022-04

Completion (planned):

Not available

Last update:

2025-07-20

Research types:

Clinical research

Research areas:

Immune system dysfunction

Interventions:

Drugs, Monoclonal antibodies and antibody drug conjugates (L01F), Antineoplastic and immunomodulating agents (L), Antineoplastic agents (L01), Daratumumab (L01FC01), CD38 (Clusters of Differentiation 38) inhibitors (L01FC)

Priv. Sector Partner:

Not available

Sponsors:

Norwegian ME Association, Kavli Trust, M.E. Network in Norway, Focus on ME

Links

Clinical trial website

Project description

This pilot study will use subcutaneous injections of the anti-CD38 antibody daratumumab in six patients with moderate to severe ME/CFS in an effort to reset the humoral immune response in ME/CFS. The main purpose is to evaluate the feasibility and safety of daratumumab subcutaneous injections in these patients. The investigators will also also collect efficacy data.

Patients included must have ongoing ME/CFS for at least two years, diagnosed with a defined onset, e.g. after an initial infection or other immunological trigger. The primary outcome measures are safety and tolerability as measured by treatment-emergent adverse events (CTCAE grade 1). Adverse events will be recorded bi-weekly during treatment period (weeks 12 to 20) and monthly until the end of study (52 weeks), and a total evaluation performed at end of study. A safety review will be performed after two patients have completed treatment.

Secondary endpoints include Changes from baseline/run-in through follow-up across SF36 domains including SF36 Physical Function (SF36-PF) and SF36 Bodily pain (SF36-BP), DSQ-SF, self-reported function level and steps per 24 hours.

Description adapted from cinical trial website: see link above.