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Keep this study
Lead
Bristol-Myers Squibb
Dose-escalation, multidose study of MDX-1411, a fully human nonfucosylated monoclonal antibody (mAb) targeting the CD70 transmembrane cell-surface protein, which is highly expressed in B-cell malignancies such as CLL and MCL.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed diagnosis of relapsed/refractory MCL or hematologically/bone marrow confirmed relapsed/refractory CLL that is not amenable to cure by surgery or other means and has failed at least 1 prior systemic therapy;
Subjects may have been treated with up to 6 prior systemic therapies for relapsed/refractory disease or have become intolerant to a systemic therapy
For MCL, must have measurable disease
At least 4 weeks since the last systemic therapy, including RT, for the treatment of MCL/CLL;
At least 4 weeks since taking any corticosteroids prior to the first dose of MDX-1411
ECOG Performance Status 0 to 2;
No known positivity for human immunodeficiency virus (HIV) and no active infection with Hepatitis B or Hepatitis C;
You may not be if
History of severe hypersensitivity reactions to other monoclonal antibodies;
Use of other investigational drugs within 30 days before study drug administration
Prior treatment with any other anti-CD70 antibody;
Active infection requiring i.v. systemic therapy within 4 weeks of receiving the first dose of MDX-1411;
Evidence of bleeding diathesis or coagulopathy;
Active autoimmune disease requiring immunosuppressive therapy;
Known current drug or alcohol abuse;
Underlying medical conditions that will make the administration of MDX-1411 hazardous
