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

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ClinicalTrials.gov Identifier: NCT03571568
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
BioInvent International AB

Tracking Information
First Submitted Date  ICMJE May 17, 2018
First Posted Date  ICMJE June 27, 2018
Last Update Posted Date April 1, 2019
Actual Study Start Date  ICMJE May 16, 2018
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • 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 ]
    Assess the safety and tolerability profile of BI-1206 when administered in combination with Rituximab
  • 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) [ Time Frame: During the 28-day treatment period on induction therapy ]
    Select the RP2D
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03571568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • Evaluation of PK parameters for BI-1206. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 1 year ]
    Study the PK profile of BI-1206 together with Rituximab
  • Evaluation of PK parameters for BI-1206. Area under the plasma concentration-time curve (AUC) [ Time Frame: Up to 1 year ]
    Study the PK profile of BI-1206 together with Rituximab
  • Evaluation of PK parameters for Rituximab. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 1 year ]
    Study the PK profile of Rituximab together with BI-1206
  • Evaluation of PK parameters for Rituximab. Area under the plasma concentration-time curve (AUC) [ Time Frame: Up to 1 year ]
    Study the PK profile of Rituximab together with BI-1206
  • Evaluation of ADA response to BI 1206 [ Time Frame: Up to 1 year ]
    Assess the immunogenicity of BI-1206
  • Measurement of B cell depletion [ Time Frame: Up to 1 year ]
    Evaluate the effect of BI-1206
  • Assessment of overall response rate (response criteria for malignant lymphoma (Cheson, 2014). RR) [ Time Frame: Up to 1 year ]
    Assess possible anti-tumor activity of BI-1206
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of BI-1206 in Combination With Rituximab in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma
Official Title  ICMJE 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
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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 rituximab
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Indolent B-Cell Non-Hodgkin Lymphoma
Intervention  ICMJE Biological: BI1206
375 mg/m2, as per SmPC
Other Name: Rituximab
Study Arms  ICMJE Experimental: BI-1206
BI-1206 IV Standard 3+3 Dose-Escalation Design
Intervention: Biological: BI1206
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marie Lindell Andersson +46708591816 marie.lindell.andersson@bioinvent.com
Listed Location Countries  ICMJE Poland,   Spain,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03571568
Other Study ID Numbers  ICMJE 17-BI1206-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All information concerning the product as well as any matter concerning the operation of the Sponsor, such as clinical indications for the drug, its formula, methods of manufacture and other scientific data relating to it, that have been provided by the Sponsor and are unpublished, are confidential and must remain the sole property of the Sponsor. The Investigator will agree to use the information only for the purposes of carrying out this studytrial and for no other purpose unless prior written permission from the Sponsor is obtained.
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Within one year from end of study
Access Criteria: Paper copy of CSR
Responsible Party BioInvent International AB
Study Sponsor  ICMJE BioInvent International AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mats Jerkeman, MD PhD Senior Consultant and Adjunct Professor, Skane Univ Hospital, Lund, Sweden
PRS Account BioInvent International AB
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP