MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)

The Aim of this phase 1b/2 trial (MIL62 Plus Lenalidomide) is to find the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).

Inclusion criteria

• Adult patients, >=18 years of age;
• Patients with either histologically documented CD20-positive MZL or FL, WHO grade 1, 2 or 3a
• Evidence of progression or lack of response following at least 1 prior treatment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter > 1.5 cm and a short axis ≥ 10mm
• Adequate hematologic function (unless abnormalities are related to NHL)
• Life expectancy >6 months
• Able and willing to provide written informed consent and to comply with the study protocol

Exclusion criteria

• Evidence ongoing transformation into aggressive NHL
• Central nervous system lymphoma
• Patients with progressive multifocalleukoencephalopathy (PML)
• Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start
• Prior use of any anti-cancer vaccine
• Prior administration of radiotherapy 42 days prior to study entry
• Prior administration of chemotherapy 28 days prior to study entry
• History of prior malignancy within the last 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
• Known hypersensitivity to thalidomide or lenalidomide
• Regular treatment with corticosteroids prior to the start of cycle 1, unless administered for indications other than NHL at a dose equivalent to < 20 mg/day prednisone
• Any serious active disease or co-morbid medical condition (such as New York Heart Association Class II or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)
• Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
• Pregnant or lactating females