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A Phase I/II Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered Subcutaneously in Patients with B-cell Non-Hodgkin Lymphoma (NHL)
Principal Investigator (?)
Lansigan, Frederick
Study Number
An open-label, dose-escalation trial of the safety, tolerability, pharmacokinetics (PK), biological, and clinical activity of DI-Leu16-IL2 administered to patients with CD20 (B-lymphocyte antigen CD20) positive Non-Hodgkin Lymphoma (NHL) that have failed standard rituximab-containing therapy. Following peripheral blood B cell depletion with rituximab (if needed) each patient will receive DI-Leu16-IL2 administered as a subcutaneous (SC) injection for three consecutive days every three weeks (21 day cycle). Three to six (3-6) patients will be enrolled in each cohort. Patients may receive 6 cycles of DI-Leu16-IL2 approximately thrice weekly for 3 weeks for a total of 18 doses. At the end of the study, patients may be enrolled into an open-label extension study (Study AO-101-EXT), at the discretion of the investigator. 
Phase (?)
Phase III
Sponsor (?)
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