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

BioInvent International AB0 sites52 target enrollmentNovember 22, 2018

ConditionsIndolent B-Cell Non-Hodgkin Lymphoma MedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disorders Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Indolent B-Cell Non-Hodgkin Lymphoma
Sponsor: BioInvent International AB
Enrollment: 52
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 22, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

BioInvent International AB

Eligibility Criteria

Inclusion Criteria

•1\. Are \= 18 years of age by initiation of study treatment.
•2\. Provide written (signed and dated) informed consent.
•3\. Are capable of cooperating with treatment and follow\-up.
•4\. Have B\-cell NHL proven by histology, with histological subtypes limited to FL (except FL3B), MCL and MZL.
•5\. Have measurable nodal disease, defined as the presence of \=1 nodal lesion that measures \=1\.5 cm in a single dimension as assessed by computerized tomography (CT) or magnetic resonance imaging (MRI).
•6\. Are willing to undergo lymph node biopsies or biopsies of other involved tissue (besides bone marrow). However, if the investigator feels that a tissue biopsy is not technically feasible, then the subject will not be required to undergo biopsies. If viable frozen tissue (not formalin\-fixed) from a previous standard of care biopsy in the previous 8 weeks prior to consent is available, a new biopsy at screening is not required.
•7\. Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists, the investigator judges available standard therapy as not being appropriate for the subject, or is declined by the subject. Rituximab refractory disease is defined as:
•Lack of CR or PR during rituximab\-containing treatment comprising \=2 doses of \=375 mg/m2, or
•Occurrence of progressive disease after completion of a regimen of rituximab\-containing therapy comprising \=2 doses of \=375 mg/m2, or
•Occurrence of progressive disease during rituximab maintenance therapy or within 6 months of completion of rituximab maintenance therapy.

Exclusion Criteria

•1\. Have had an allogenic bone marrow or stem cell transplant within 12 months prior to the first dose of BI\-1206\.
•2\. Have presence of active chronic graft versus host disease of any grade/severity.
•3\. Have current leptomeningeal lymphoma or compromise of the central nervous system.
•4\. Have transformed lymphoma from a pre\-existing indolent lymphoma. Subjects with a previous history of transformation, but on this disease episode have a biopsy proven indolent recurrence, may be included. Subjects with proven or suspected Richter transformation are not eligible.
•5\. Have Waldenstrom’s Macroglobulinemia or FL3B, due to the high risk of transformation while on study.
•6\. Need systemic doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) while on the study other than as pre\-medication. During the screening period, doses of up to 20 mg/day may be given but the dose must be reduced to 10 mg/day within 7 days prior the first dose of study drug. Inhaled or intranasal steroids are permissible.
•7\. Have known or suspected hypersensitivity to rituximab or BI\-1206\. Previous isolated IRRs are not to be considered a reason for exclusion.
•8\. Have cardiac or renal amyloid light\-chain amyloidosis.
•9\. Have received any of the following:
•Chemotherapy or small molecule products with 2 weeks of first dose of BI\- 1206 and/or