Anti-CD19 and multiple sclerosis

In response to a query re anti-CD19 treatment. Unfortunately, you can't access anti-CD19 treatment at present it is not a licensed therapy. However, we are doing a clinical trial of this agent so if you are interested you can speak to your neurologist or MS clinical nurse specialist. Before being referred for screening you should make sure you meet the eligibility criteria below.  For logistic reasons you need to live in or near London (commutable) to be suitable for screening. The trial is being run at the Royal London Hospital (map). If you want more information you can contact us via the following email address: trials@msuclp.org.
Trial: Safety and Efficacy Study of MEDI-551, a B-cell Depleting Agent, to Treat Multiple Sclerosis;  NCT01585766

Inclusion Criteria:
  1. 18 Years to 55 years
  2. Confirmed RRMS according to revised 2010 McDonald criteria and MRI brain lesions consistent with MS
  3. At least 2 documented relapses within the past 3 years prior to screening or at least one documented relapse within 1 year prior to screening
  4. EDSS between 0.0 and 5.0 at screening
  5. Subjects in the phase 1 part should have at least 1 but not more than 15 gadolinium-enhancing lesion(s) by cranial MRI at screening
  6. Subjects participating in the phase 2 part can have 0-15 gadolinium-enhancing lesion(s)
Exclusion Criteria:

  1. Subjects with impaired renal function
  2. Major surgery within 8 weeks of the screening visit
  3. Subjects who are unable to undergo cranial MRI scan
  4. A history of hypersensitivity to Gd-containing MRI contrast agents
  5. A history of hypersensitivity to natural or recombinant interferon beta (Phase 2)
  6. Has received at any time monoclonal antibodies or experimental B-cell depleting agents
  7. Receiving monthly methylprednisone or equivalent glucocorticoid for disease modification for RRMS
  8. Known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, methylprednisolone or equivalent glucocorticoid, or to any component of the investigational drug
  9. Diagnosis of a non-RRMS neuro-inflammatory or demyelinating disease
  10. Any history of opportunistic infection or the presence of active infection within two months prior to screening or any herpes zoster infection that has not resolved within 12 weeks prior to screening
  11. Any clinically significant findings during the screening phase, including physical, neurological, laboratory, or ECG examination as per protocol 
"For those of you interested in biology: the reason why I think anti-CD19 may prove to superior to anti-CD20 treatment (rituximab, ocrelizumab, ofatumumab) is that it targets plasmablasts and possibly plasma cells; the picture below shows you the B-cell lineage and the expression patterns of both CD20 and CD19. Plasmablasts and plasma cells are the factory cells that make large amounts of antibody. There is a lot of data linking these cells to MS. Therefore if we can kill or suppress these cells we may have additional benefits. The good news for MSers is that this is another novel treatment that is being tested in MS and is likely to be a very efficacious agent."

CoI: I am the principal investigator of the MEDI-551 trial at Barts Health and MS@UCLP and I sit on the steering committee that designed, and will help, run the trial.

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