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

B

BioInvent International

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Indolent B-Cell Non-Hodgkin Lymphoma

Treatments

Biological: BI-1206

Study type

Interventional

Funder types

Industry

Identifiers

NCT03571568
17-BI-1206-02

Details and patient eligibility

About

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

Full description

This is a Phase 1/2a, dose escalation, consecutive-cohort, open-label trial of BI-1206 in combination with rituximab in subjects with indolent relapsed or refractory B-cell NHL, subtypes FL (except FL grade 3B), MZL, and MCL. The trial consists of 2 main parts: Phase 1 with two different Arms assessing IV or SC dosing of BI-1206,with dose escalation cohorts and selection of the RP2D of IV dosing (ivRP2D)and the RP2D of SC dosing (scRP2D) of BI-1206 in combination with rituximab (administered IV). Phase 2a with two expansion cohorts evaluating the ivRP2D and scRP2D of BI-1206 in combination with rituximab (administered IV). Subjects in each phase (Phase 1 and 2a) and dosing Arms will receive 1 cycle 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 ( using the same dose and route of administration as induction therapy) 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).

Enrollment

98 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

* 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

98 participants in 2 patient groups

BI-1206 IV
Experimental group
Description:
BI-1206 IV Standard 3+3 Dose-Escalation Design
Treatment:
Biological: BI-1206
BI-1206 SC
Experimental group
Description:
BI-1206 SC Adaptive Dose Escalation Design (Bayesian logistic regression model (BLRM)
Treatment:
Biological: BI-1206

Trial contacts and locations

22

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Central trial contact

Andres McAllister, MD, PhD; Erika Bågeman

Data sourced from clinicaltrials.gov

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