QUILT-3.002: N-803 in Patients With Relapse/Refractory iNHL in Conjunction With Rituximab

Inclusion Criteria

• DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of iNHL (Follicular lymphoma grade 1, 2, 3a; marginal zone lymphoma; small lymphocytic lymphoma or lymphoplasmacytic lymphoma) after treatment with at least 1 or more prior rituximab-containing regimens. - Anti-CD20 mAb-refractory disease is defined as progressive disease while on rituximab (or another treatment of an anti-CD20 monoclonal antibody) or progression within 6 months of rituximab-containing (or another treatment of an anti-CD20 antibody-containing) therapy. - Anti-CD20 mAb-sensitive disease is defined by a response to a prior rituximab-containing (or another treatment of an anti-CD20 monoclonal antibody) regimen, and relapse more than 6 months from the last administration of rituximab-containing (or another treatment of an anti-CD20 antibody-containing) therapy. - Measurable disease: - At least one lymph node group ≥ 1.5 cm in longest transverse dimension. Patients with cutaneous only disease may be enrolled if they have a clearly measurable skin lesion. - Relapsed or Refractory iNHL that has progressed during or following 1 or more prior systemic rituximab-containing (or another treatment of an anti-CD20 antibody-containing) regimens for lymphoma PRIOR/CONCURRENT THERAPY: - No anti-lymphoma treatments within 28 days before the start of study treatment. - Must have recovered from side effects of prior treatments. PATIENT CHARACTERISTICS: Performance Status • ECOG 0, 1, or 2 Renal Function • Glomerular Filtration Rate (GFR) > 40mL/min or Serum creatinine ≤ 1.5 X ULN Bone Marrow Reserve - Platelets ≥30,000/uL - Hemoglobin ≥ 8g/dL - Absolute Lymphocytes ≥800/uL - ANC/AGC ≥750/uL Hepatic Function - Total bilirubin ≤ 2.0 X ULN (unless Gilbert's Syndrome or disease infiltration of liver is present) - AST, ALT ≤ 3.0 X ULN, or ≤ 5.0 X ULN (if liver lymphoma is present) - No positive Hep C serology or active Hep B infection Cardiovascular - No congestive heart failure < 6 months - No unstable angina pectoris < 6 months - No myocardial infarction < 6 months - No history of ventricular arrhythmias or severe cardiac dysfunction - No history of uncontrollable supraventricular arrhythmias - No NYHA Class > II CHF - No marked baseline prolongation of QT/QTc interval Pulmonary • Normal clinical assessment of pulmonary function Other - Negative serum pregnancy test if female and of childbearing potential - Women who are not pregnant or nursing - Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study - No known autoimmune disease other than corrected hypothyroidism - No known prior organ allograft or allogeneic transplantation - Not HIV positive - No active CNS involvement with lymphoma - No psychiatric illness/social situation that would limit compliance - No other illness that in the opinion of the investigator would exclude the subject from participating in the study - Must provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations - No active systemic infection requiring parenteral antibiotic therapy - No disease requiring systemic immunosuppressive therapy (inhaled or topical steroids are allowed). Adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. - No known histologic transformation from iNHL to DLBCL