A Study of BI-1206 in Combination With Rituximab in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    30
  • sponsor
    BioInvent International AB
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Updated on 10 March 2022
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Summary

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

Description

This is a Phase 1/2a, dose escalation, consecutive-cohort, open-label studytrial of BI-1206 in combination with rituximab in subjects with indolent relapsed or refractory B-cell NHL. The studytrial will consist of 2 main parts: Phase 1 (with dose escalation cohorts using a 3+3 dose-escalation design and selection of the RP2D), and Phase 2a (the escalationexpansion cohort at the RP2D). Subjects in each phase will receive 1 cycle (4 doses) of induction therapy with BI-1206 in combination with rituximab. Subjects who show clinical benefit (complete response [CR], partial response [PR], or stable disease [SD]) at Week 6 will continue onto maintenance therapy and receive BI-1206 and rituximab once every 8 weeks (relative to previous maintenance dose) for up to 6 maintenance cycles, or up to 1 year from first dose of BI-1206 (whichever occurs first).

Details
Condition Indolent B-Cell Non-Hodgkin Lymphoma
Treatment BI1206
Clinical Study IdentifierNCT03571568
SponsorBioInvent International AB
Last Modified on10 March 2022

Eligibility

 Yes No Not Sure

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 FL3B), MCL and marginal zone lymphoma (MZL)
Have measureable 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

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 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
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