Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat Non-Hodgkin's Lymphoma (NHL)

Inclusion Criteria

• •1. Male or female patients ≥ 18 years of age.
• •2. Histologically-confirmed diagnosis according to Revised European American Lymphoma/World Health Organization classification, of the following B-cell lymphomas:
• •1. FL
• •2. Other indolent NHL (eg, MZL/MALT)
• •3. DLBCL
• •4. MCL
• •3. Patients' NHL must have progressed after at least 1 prior rituximab containing regimen.
• •4. One site of measurable disease by magnetic resonance imaging (MRI) or computed tomography (CT) scan defined as at least one lesion that measures at least 1.5 × 1.5 cm.
• •Exception:
• •For patients with MCL only, patients with nonmeasurable disease but evaluable sites (bone marrow, spleen, peripheral blood, gastrointestinal tract) can be enrolled.
• •5. Patients who have previously received an autologous stem cell transplantation must be at least 4 weeks post-transplant before study drug administration and must have exhibited a full haematological recovery.
• •6. Discontinued previous monoclonal antibody therapy (except rituximab) or radioimmunotherapy administration for at least 60 days before study drug administration.
• •7. Off rituximab for at least 14 days before the screening visit and be confirmed to have either no response or have disease progression after rituximab treatment.
• •8. Patients with DLBCL had a positive \[18F\]fluorodeoxyglucose-positron emission tomography (FDG-PET) scan at baseline (Cheson 2007 response criteria).
• •9. Life expectancy of \> 3 months.
• •10. Eastern Cooperative Oncology Group (ECOG) performance status of \< 3.
• •11. Laboratory criteria at screening:
• •1. Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L
• •2. Platelet count ≥ 75 × 10\^9/L without previous transfusion within 10 days of first study drug administration
• •3. Haemoglobin ≥ 8.0 g/dL (may have been transfused)
• •4. Serum creatinine \< 2.0 x upper limit of normal (ULN)
• •5. Total bilirubin ≤ 2.0 × ULN
• •6. Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
• •12. If a female of childbearing potential, a negative pregnancy test must be confirmed before enrolment and use of double-barrier contraception or oral contraceptive plus barrier contraceptive must be used during the study and for 3 months after the last dose, or confirmation of having undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation.
• •13. If a male, an effective barrier method of contraception must be used during the study and for 3 months after the last dose if the patient is sexually active with a female of childbearing potential.
• •14. Able to comply with all study-related procedures, medication use, and evaluations.
• •15. Able to understand and give written informed consent and comply with the study protocol.