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

Eligibility Criteria

• 1. Are ≥ 18 years of age by initiation of study treatment.
• 2. Have B-cell NHL proven by histology, with histological subtypes limited to follicular lymphoma (FL) (except FL grade 3B), MCL and marginal zone lymphoma (MZL)
• 3. Have measurable nodal disease
• 4. Are willing to undergo lymph node biopsies or biopsies of other involved tissue
• 5. Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists
• 6. Have received at least one line of conventional previous therapy which must include at least one rituximab-based regimen
• 7. Have a life expectancy of at least 12 weeks
• 8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• 9. Have CD20+ malignancy
• 10. Have hematological and biochemical indices within prespecified ranges
• 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