Description:
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
Title
- Brief Title: A Study of BI-1206 in Combination With Rituximab in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
17-BI1206-02
- NCT ID:
NCT03571568
Conditions
- Indolent B-Cell Non-Hodgkin Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
BI1206 | Rituximab | BI-1206 |
Purpose
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
Detailed 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).
Trial Arms
Name | Type | Description | Interventions |
---|
BI-1206 | Experimental | BI-1206 IV Standard 3+3 Dose-Escalation Design | |
Eligibility 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 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab |
Time Frame: | During the 28-day treatment period on induction therapy |
Safety Issue: | |
Description: | Assess the safety and tolerability profile of BI-1206 when administered in combination with Rituximab |
Secondary Outcome Measures
Measure: | Evaluation of PK parameters for BI-1206. Maximum observed plasma concentration (Cmax) |
Time Frame: | Up to 1 year |
Safety Issue: | |
Description: | Study the PK profile of BI-1206 together with Rituximab |
Measure: | Evaluation of PK parameters for BI-1206. Area under the plasma concentration-time curve (AUC) |
Time Frame: | Up to 1 year |
Safety Issue: | |
Description: | Study the PK profile of BI-1206 together with Rituximab |
Measure: | Evaluation of PK parameters for Rituximab. Maximum observed plasma concentration (Cmax) |
Time Frame: | Up to 1 year |
Safety Issue: | |
Description: | Study the PK profile of Rituximab together with BI-1206 |
Measure: | Evaluation of PK parameters for Rituximab. Area under the plasma concentration-time curve (AUC) |
Time Frame: | Up to 1 year |
Safety Issue: | |
Description: | Study the PK profile of Rituximab together with BI-1206 |
Measure: | Evaluation of ADA response to BI 1206 |
Time Frame: | Up to 1 year |
Safety Issue: | |
Description: | Assess the immunogenicity of BI-1206 |
Measure: | Measurement of B cell depletion |
Time Frame: | Up to 1 year |
Safety Issue: | |
Description: | Evaluate the effect of BI-1206 |
Measure: | Assessment of overall response rate (response criteria for malignant lymphoma (Cheson, 2014). RR) |
Time Frame: | Up to 1 year |
Safety Issue: | |
Description: | Assess possible anti-tumor activity of BI-1206 |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | BioInvent International AB |
Last Updated
October 5, 2020