Multiple Sclerosis Clinical Trial
OBJECTIVES: I. Evaluate the safety and immunogenicity of single and multiple doses of
M-T412, a chimeric murine-human anti-CD4 monoclonal antibody, in patients with multiple
sclerosis.
II. Evaluate the pharmacokinetics of M-T412. III. Obtain preliminary data on the clinical
response to M-T412.
PROTOCOL OUTLINE: This is an open label, dose escalating study. Escalating doses of M-T412
are administered to cohorts of 5 patients each receiving a single dose intravenously over 2
hours.
Patients who complete the single dose assessment of M-T412 may receive up to 3 additional
single doses of M-T412 IV over 2 hours, with each repeated dose given at least 1 month
apart.
Then, patients receive one dose level of M-T412 IV over 2 hours at 3 month intervals over a
period of 12 months for a total of 5 doses. Once recovery of CD4 cells is obtained, the next
scheduled infusion of M-T412 begins. Patients are omitted from study if CD4 cells remain
attenuated following 2 scheduled infusion sessions.
Patients are followed at 3, 6, 12, and 24 months after the first infusion.
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Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
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