NCT06415864

Oral Cladribine B-cell Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To study the impact of cladribine on peripheral and intrathecal B-cell, plasma cells, T cells and Tregs

Detailed description

Primary: To quantify the temporal changes of memory B cells (CD19+/CD27+/IgD-/+), plasmablasts (CD19-/CD138+/CD38+) and T cells (CD4/CD45RA-/+, CCR7-/+, CD8+/CD45RA-/+/CCR7-/+), Tregs (CD4/CD8)/CD25+/CD127-/Fox3 P+) in the peripheral venous blood of pwMS with RRMS over 96w of treatment with oral cladribine. These will be compared to the populations of non-memory or class-switched B cells (immature/transitional B cells CD10+/CD38+/CD19+, immature regulatory B cells CD10+/CD38+/CD19+/CD24+/IL-10+, mature B cells CD10-/CD38+/CD19+). Secondary: 1. To study the effects of oral cladribine on: 1. CSF OCBs and free immunoglobulin kappa and lambda light chain levels (FLC). 2. CSF markers of inflammation, in particular CXCL-13 and urine markers of inflammation (neopterin). 3. CSF markers of neuroaxonal damage, in particular free neurofilament light chains. 4. On the peripheral repertoire B-cells (immunoglobulin) and T-cells (T cell receptor) and plasma cells (soluble receptors). 2. To compare CSF OCB positivity and CSF light chain levels with a contemporary control group of alemtuzumab treated pwMS (historical data). Tertiary: 1. To compare B and T cell repertoire with a contemporary control group of alemtuzumab treated pwMS (historical data). 2. To evaluate the effect of changes in the immune cell profile on clinical measures of disability, MRI activity and PROMS.

Conditions

• Multiple Sclerosis

Timeline

• Start date: 2019-07-01
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2024-05-16
• Last updated: 2026-02-04
• Results posted: 2026-02-04

Locations

1 site across 1 country: United Kingdom