A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
Phase 1/2a Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab
BioInvent International AB
140 participants
May 16, 2018
INTERVENTIONAL
Conditions
Summary
Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab
Eligibility
Inclusion Criteria10
- Are ≥ 18 years of age by initiation of study treatment.
- 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)
- Have measurable nodal disease
- Are willing to undergo lymph node biopsies or biopsies of other involved tissue
- Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists
- Have received at least one line of conventional previous therapy which must include at least one rituximab-based regimen
- Have a life expectancy of at least 12 weeks
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Have CD20+ malignancy
- Have hematological and biochemical indices within prespecified ranges
Exclusion Criteria21
- Have had an allogenic bone marrow or stem cell transplant within 12 months
- Have presence of active chronic graft versus host disease
- Have current leptomeningeal lymphoma or compromise of the central nervous system
- Have transformed lymphoma from a pre-existing indolent lymphoma
- Have Waldenstrom's Macroglobulinemia or FL grade 3B,
- Need systemic doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) while on the study trial other than as pre-medication.
- Have known or suspected hypersensitivity to rituximab or BI-1206
- Have cardiac or renal amyloid light-chain amyloidosis
- Have received any of the following:
- Chemotherapy or small molecule products with 2 weeks of first dose of BI-1206
- Radiotherapy (except for focal symptomatic control of lymphadenopathy) within 4 weeks
- Immunotherapy within 8 weeks
- Previous lines of treatment containing BTK inhibitors for Subjects receiving BI-1206 in combination with rituximab and acalabrutinib
- Have ongoing toxic manifestations of previous treatments.
- Have the ability to become pregnant (or already pregnant or lactating/breastfeeding).
- Have had major surgery from which the subject has not yet recovered.
- Are at high medical risk because of non-malignant systemic disease including active infection on treatment with antibiotics, antifungals or antivirals.
- Are serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- Have an active, known or suspected autoimmune disease.
- Have concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association \[NYHA\])
- Have current malignancies of other types
Interventions
BI-1206 150 mg / 225 mg Subcutaneous injection BI-1206 50 mg /100 mg Intravenous infusion
Rituximab 375 mg/m2, as per SmPC
Acalabrutinib 100 mg orally as per SmPC
Locations(27)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03571568