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

NCT03571568

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

Related Conditions:
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
BI1206RituximabBI-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

NameTypeDescriptionInterventions
BI-1206ExperimentalBI-1206 IV Standard 3+3 Dose-Escalation Design
  • BI1206

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

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