AFM13 in Relapsed/Refractory Cutaneous Lymphomas

Exclusion Criteria

• •Any cancer-related therapy for the current disease within 2 weeks of screening (all supportive care measures are allowed)
• •Major surgery within 2 weeks prior to first dose of study drug
• •Evidence of active central nervous system (CNS) involvement
• •Requirement for systemic immunosuppressive therapy (e.g. Graft-versus-Host Disease (GVHD) therapy within 12 weeks before the first dose of study drug)
• •Uncontrolled concurrent serious illness.
• •Concurrent malignancy or history of a previous malignancy within 3 years prior to first dose of the current study, unless curatively resected basal, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
• •Active infections including hepatitis B carrier status, hepatitis C virus (HCV) infection (patients must have a negative Hepatitis B and Hepatitis C viral load at screening)
• •Known HIV-positive status
• •Any significant medical conditions, laboratory abnormality, or psychiatric illness that would exclude the subject from participation or interfere with study treatment, monitoring and compliance such as:
• •unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association (NYHA) III or IV), myocardial infarction ≤ 6 months prior to first study drug, clinically significant and uncontrolled cardiac arrhythmia (e.g. atrial fibrillation/flutter ventricular cardiovascular physiology is allowed), cerebrovascular accidents ≤ 6 months before study drug start
• •severely impaired lung function
• •Serious, systemic infection requiring treatment ≤7 days before the first dose of study drug
• •Any severe, uncontrolled disease or condition which in the investigator's opinion, may put the subject at significant risk, may confound the study results, or impact the subject's participation in the study.