A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL

Exclusion Criteria

• •1. Have had an allogenic bone marrow or stem cell transplant within 12 months
• •2. Have presence of active chronic graft versus host disease
• •3. Have current leptomeningeal lymphoma or compromise of the central nervous system
• •4. Have transformed lymphoma from a pre-existing indolent lymphoma
• •5. Have Waldenstrom's Macroglobulinemia or FL grade 3B,
• •6. Need systemic doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) while on the study trial other than as pre-medication.
• •7. Have known or suspected hypersensitivity to rituximab or BI-1206
• •8. Have cardiac or renal amyloid light-chain amyloidosis
• •9. Have received any of the following:
• •1. Chemotherapy or small molecule products with 2 weeks of first dose of BI-1206
• •2. Radiotherapy (except for focal symptomatic control of lymphadenopathy) within 4 weeks
• •3. Immunotherapy within 8 weeks
• •4. Previous lines of treatment containing BTK inhibitors for Subjects receiving BI-1206 in combination with rituximab and acalabrutinib
• •10. Have ongoing toxic manifestations of previous treatments.
• •11. Have the ability to become pregnant (or already pregnant or lactating/breastfeeding).
• •12. Have had major surgery from which the subject has not yet recovered.
• •13. Are at high medical risk because of non-malignant systemic disease including active infection on treatment with antibiotics, antifungals or antivirals.
• •14. Are serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
• •15. Have an active, known or suspected autoimmune disease.
• •16. Have concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association \[NYHA\])
• •17. Have current malignancies of other types