Previously Treated CD20+ B-cell Malignancies Clinical Trial
Official title:
A Phase I Study of Subcutaneous Ocaratuzumab (Fab- and Fc-engineered Anti-CD20 Monoclonal Antibody) in Patients With Previously Treated CD20+ B-Cell Malignancies
Ocaratuzumab is a third-generation, fully humanized IgG1 monoclonal antibody (mAb) targeting
the CD20 surface marker on normal and malignant B lymphocytes. It has been optimized for an
increased binding for CD20 and an enhanced antibody dependent cell medicated cytotoxicity
(ADCC) effector function.
A previous phase I/II study of intravenously (IV) administered ocaratuzumab in
refractory/relapsed follicular lymphoma patients has concluded that ocaratuzumab is safe and
well-tolerated at doses up to 375mg/ m2 weekly for four weeks.
In this proposed phase I study, ocaratuzumab will be administered subcutaneously to patients
with previously treated CD20+ B-cell malignancies. Three dose levels (40 mg weekly x 4
doses, 80 mg weekly x 4 doses, and 80 mg weekly x 8 doses) will be investigated for safety,
tolerability, pharmacokinetic, and pharmacodynamic analyses.
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment