A Study of De-immunized DI-Leu16-IL2 Administered Subcutaneously in Participants With B-cell NHL

Inclusion Criteria

• •1. Participants with CD20-expressing B-cell NHL that is relapsed or refractory to standard therapy. Chronic lymphocytic leukemia/small lymphocytic lymphoma with peripheral blood leukemia/lymphoma cells and high-grade lymphomas are excluded.
• •2. Participants must have received prior rituximab-containing therapy.
• •3. Evaluable disease. In the absence of lymphadenopathy, splenomegaly with defects or measurable extra-medullary disease is acceptable.
• •1. The transplant occurred \>6 months ago
• •2. There is no evidence of active graft versus host disease
• •3. Systemic immunosuppressive agents (including corticosteroids) have not been received for at least 8 weeks
• •6. Karnofsky performance scale ≥70%
• •7. Life expectancy ≥12 weeks
• •8. Adequate baseline functions:
• •1. Serum creatinine ≤1.5 mg/deciliter (dL)
• •2. Total white blood cell (WBC) count ≥3000/microliter (µL) or absolute neutrophil count (ANC) ≥1000/µL
• •3. Absolute lymphocyte count ≥0.75 \* 10\^3/µL
• •4. Platelet count ≥75,000/µL
• •5. Hematocrit ≥25% or hemoglobin ≥9 grams/100 milliliters (mL)
• •6. Alanine aminotransferase (ALT) \<2.5 \* upper limit of normal (ULN)
• •7. Aspartate aminotransferase (AST) \<2.5 \* ULN
• •8. Total bilirubin (TBili) \<1.5 \* ULN
• •9. Sodium, potassium, and phosphorus levels no worse than grade 1
• •10. Chest x-ray (CXR) or computed tomography (CT) within 4 weeks prior to Day 1 with no evidence of pulmonary congestion, pleural effusions, pulmonary fibrosis, or significant emphysema. If results are questionable, participants should have additional lung function testing to exclude clinically relevant restriction or obstruction. Participants must have a forced expiratory volume (FEV-1) and diffusing capacity of the lung for carbon monoxide (DLCO) of at least 65% and 50% of expected, respectively.
• •11. Electrocardiogram (12-lead ECG) QTc ≤480 millisecond (ms)
• •12. Cardiac stress test (for example, stress thallium scan, stress echocardiography) with normal results if participant is suspected to have coronary artery disease.
• •9. Participants participating in the study are to use adequate birth control measures (abstinence, oral contraceptives, barrier method with spermicide or surgical sterilization) during the study. Females of childbearing potential must have a negative serum pregnancy test on the days of dosing. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (that is, has had menses at any time in the preceding 24 consecutive months).
• •10. Provide written informed consent prior to any screening procedures