A Study of BI-1206 in Combination With Rituximab in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma
About the study
Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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 CRITERIA
Exclusion Criteria:
- 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 FL3B,
- 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
- 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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Indolent B-Cell Non-Hodgkin Lymphoma
Age
18+
Phase
PHASE1/PHASE2
Participants Needed
98
Est. Completion Date
Sep 22, 2025
Treatment Type
INTERVENTIONAL
Sponsor
BioInvent International AB
ClinicalTrials.gov NCT Identifier
NCT03571568
Study Number
17-BI-1206-02
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