N/A
Completed N=10
Oral Cladribine B-cell Study
Source: ClinicalTrials.gov NCT06415864 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: Percent Change in Class-switched Memory B Cells From Baseline to Week 96 nh — -62.8 % change
Summary
To study the impact of cladribine on peripheral and intrathecal B-cell, plasma cells, T cells and Tregs
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Class-switched Memory B Cells From Baseline to Week 96 nh |
-62.8 | — |
| PRIMARY Percent Change in Non Class-switched Memory B Cells From Baseline to Week 96 |
-85.3 | — |
| PRIMARY Percent Change in Plasmablast From Baseline to Week 96 |
117.2 | — |
| PRIMARY Percent Change in Transitional B Cells From Baseline to Week 96 |
858.6 | — |
| PRIMARY Percent Change in Regulatory B Cells From Baseline to Week 96 |
648.3 | — |
| PRIMARY Percent Change in CD4+ Central Memory T Cells From Baseline to Week 96 |
-55 | — |
| PRIMARY Percent Change in CD4+ Naive T Cells From Baseline to Week 96 |
-47.1 | — |
| PRIMARY Percent Change in CD4+ TEMRA Cells From Baseline to Week 96 |
30.4 | — |
| PRIMARY Percent Change in CD4+ Effector Memory T Cells From Baseline to Week 96 |
0.82 | — |
| PRIMARY Percent Change in CD8+ Central Memory T Cells From Baseline to Week 96 |
26 | — |
| PRIMARY Percent Change in CD8+ Naive T Cells From Baseline to Week 96 |
-25 | — |
| PRIMARY Percent Change in CD8+ TEMRA Cells From Baseline to Week 96 |
60.81 | — |
| PRIMARY Percent Change in CD8+ TEM Cells From Baseline to Week 96 |
4.56 | — |
| PRIMARY Percent Change in Regulatory T Cells From Baseline to Week 96 |
40.02 | — |
| SECONDARY Changes in CSF of κ Free Light Chain (KFLC) From Baseline to Week 48 and Week 96 |
164.5; 71.3; 64.4 | — |
| SECONDARY Change in CSF Oligoclonal Band (OCB) Positivity From Baseline to Week 48 and Week 96 |
4; 2; 3; 1 | — |
| SECONDARY Changes in CSF of λ Free Light Chain (LFLC) Index From Baseline to Week 48 and Week 96 |
31.94; 29.48; 27.18 | — |
| SECONDARY Change in CSF CXCL-13 Levels From Baseline to Week 96 |
88.6; 39.4; 19.1 | — |
| SECONDARY Change in Urine Neopterin Levels From Baseline to Week 96 |
224.64; 355.87; 136.99 | — |
| SECONDARY Change in CSF Neurofilament Light Chain (NfL) Levels From Baseline to Week 96 |
534.42; 271.77; 301.13 | — |
| SECONDARY Change in CSF Soluble CD138 Levels From Baseline to Week 96 |
0.25; 0.14; 0.09 | — |
| SECONDARY Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96 |
1.08; 0.99; 1.00; 0.11; 0.13; 0.05 | — |
Eligibility Criteria
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 /3x upper limit of normal of site reference ranges, potassium 5.5mmol/l, sodium 130 umol/l)
Data sourced from ClinicalTrials.gov (NCT06415864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.