A Phase I Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered Subcutaneously in Patients with B-cell Non-Hodgkin Lymphoma (NHL)
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.
View more details from ClinicalTrials.gov.
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Please Note: Any eligibility criteria noted are subject to change. Our research nurses can provide you with the most current eligibility and exclusion criteria. Any study involvement to be undertaken must ultimately be determined on an individual basis.