Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)

Exclusion criteria

• . Prior treatment with rituximab within 90 days.
• . Deficiency of iron, folic acid and vitamin B12 prior to treatment phase
• . Abnormal liver function as indicated by a direct bilirubin above normal level, and/or an AST or ALT level \> 2x upper limit of normal. Please note elevated indirect bilirubin due to hemolysis is not an exclusion criteria.
• . Elevated bilirubin not due to active hemolysis. Any elevation of bilirubin \>ULN will require Sponsor review and approval for subject enrollment into the trial.
• . Active aggressive lymphoma requiring therapy or an active non-lymphatic malignant disease other than basal cell carcinoma or carcinoma in situ (CIS) of the cervix.
• . Presence or suspicion of active bacterial or viral infection, in the opinion of the Investigator, at screening or severe recurrent bacterial infections.
• . Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days prior to screening period.
• . Pregnant, breast-feeding, or intending to conceive during the course of the study, including the Post-Treatment Phase.