Oral Cladribine B-cell Study

NCT06415864•Queen Mary University of London

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with MS who are being treated with oral cladribine at Barts Health NHS Trust will be approached to participate in this study.
•Patients must be willing and able to undergo lumbar punctures
•Patients who are OCB positive in their CSF (previous diagnostic lumbar puncture)

Exclusion Criteria

•Ineligible for oral cladribine under NHS England prescribing guidelines and those participating in MAGNIFY-MS study (cladribine tablets in active MS)
•Unsuitable to have a lumbar puncture, for example spinal deformity, tethered cord syndrome or the use of aspirin or anticoagulants, and those unable to comply with study requirements, including frequency of visits and lumbar punctures.
•Presence of comorbidities in which the administration of cladribine is contraindicated.
•Abnormal baseline investigations (WBC\<3 x 10\*9/l, lymphocytes \<1.0 x 10\*9/l, neutrophil count \<1.5 x 10\*9/l, platelet count \<100 x 10\*9, haemoglobin \<110g/l, LFT\>/3x upper limit of normal of site reference ranges, potassium \<2.8mmol/l or \>5.5mmol/l, sodium \<125 mmol/l, creatinine \>130 umol/l)

Locations (1)

Barts Health NHS Trust

London, United Kingdom

Key Dates

Start Date

July 1, 2019

Primary Completion Date

January 31, 2024

Completion Date

January 31, 2024

Last Updated

February 4, 2026

Enrollment

ACTUAL participants

Conditions

Multiple Sclerosis

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Secondary Progressive Multiple Sclerosis (SPMS)

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RECRUITINGNA

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Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Oral Cladribine B-cell Study

Inclusion Criteria

Exclusion Criteria

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