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news.Genmab has completed enrollment in the phase I/II study of HuMax-CD20 in patients with chronic lymphocytic leukemia.
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A total of 33 patients have been enrolled in this study, with 27 patients included in the highest dose group, where they receive an initial dose of 500mg followed by three weekly doses of 2,000mg.
The study is an open-label dose escalation trial with three dose cohorts. Three patients in the first dose cohort received an initial dose of 100mg followed by three weekly doses of 500mg, in the second dose cohort three patients received a dose of 300mg followed by three weekly doses of 1,000mg and in the third cohort 27 patients receive an initial dose of 500mg followed by three weekly doses of 2,000mg. Treatment is ongoing at the highest dose level.
The first important milestone for this study, the safety of using HuMax- CD20 in these patients at the planned dose levels, seems to have been achieved since no side effects limiting the continued recruitment of patients were observed.
The total follow up period for this study is 12 months from treatment start and the primary endpoint of the trial is objective response over the period from screening to week 19.