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

Sponsor
BioInvent International AB (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03571568
Collaborator
(none)
30
Enrollment
9
Locations
1
Arm
67.5
Anticipated Duration (Months)
3.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Biological: BI1206
 Phase 1/Phase 2

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Phase 1/2a, dose escalation, consecutive-cohort, open-label study trial of BI-1206 in combination with rituximabPhase 1/2a, dose escalation, consecutive-cohort, open-label study trial of BI-1206 in combination with rituximab
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 16, 2018
Anticipated Primary Completion Date :
Mar 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: BI-1206

BI-1206 IV Standard 3+3 Dose-Escalation Design

Biological: BI1206
375 mg/m2, as per SmPC
Other Names:
  • Rituximab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab [During the 28-day treatment period on induction therapy]

      Assess the safety and tolerability profile of BI-1206 when administered in combination with Rituximab

    2. Determining the MTD of BI-1206 at the same dose level experiencing a BI-1206 or Rituximab-related or possibly related dose-limiting toxicity (DLT) [During the 28-day treatment period on induction therapy]

      Select the RP2D

    Secondary Outcome Measures

    1. Evaluation of PK parameters for BI-1206. Maximum observed plasma concentration (Cmax) [Up to 1 year]

      Study the PK profile of BI-1206 together with Rituximab

    2. Evaluation of PK parameters for BI-1206. Area under the plasma concentration-time curve (AUC) [Up to 1 year]

      Study the PK profile of BI-1206 together with Rituximab

    3. Evaluation of PK parameters for Rituximab. Maximum observed plasma concentration (Cmax) [Up to 1 year]

      Study the PK profile of Rituximab together with BI-1206

    4. Evaluation of PK parameters for Rituximab. Area under the plasma concentration-time curve (AUC) [Up to 1 year]

      Study the PK profile of Rituximab together with BI-1206

    5. Evaluation of ADA response to BI 1206 [Up to 1 year]

      Assess the immunogenicity of BI-1206

    6. Measurement of B cell depletion [Up to 1 year]

      Evaluate the effect of BI-1206

    7. Assessment of overall response rate (response criteria for malignant lymphoma (Cheson, 2014). RR) [Up to 1 year]

      Assess possible anti-tumor activity of BI-1206

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory University Hospital Atlanta Georgia United States 30322
    2 Szpital Specjlistyczny Grudziadz Poland 86-300
    3 Małopolskie Centrum Medyczne Krakow Poland
    4 Hospital ICO, Trias i Pujol Badalona Spain
    5 Hospital Duran i Reynals Av. Barcelona Spain
    6 Hospital Universitari Vall d'Hebron Barcelona Spain
    7 University Hospital Fundacion Jimenez Diaz Madrid Spain
    8 Department of Oncology, Skåne University Hospital Lund Sweden SE-22185
    9 Department of Oncology, Academical Hospital Uppsala Sweden 751 85

    Sponsors and Collaborators

    • BioInvent International AB

    Investigators

    • Principal Investigator: Mats Jerkeman, MD PhD, Senior Consultant and Adjunct Professor, Skane Univ Hospital, Lund, Sweden

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BioInvent International AB
    ClinicalTrials.gov Identifier:
    NCT03571568
    Other Study ID Numbers:
    • 17-BI-1206-02
    First Posted:
    Jun 27, 2018
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Lymphoma, B-Cell
    Rituximab

    Study Results

    No Results Posted as of Mar 2, 2022