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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

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
Indolent B-Cell Non-Hodgkin Lymphoma 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
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
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: BI-1206
BI-1206 IV Standard 3+3 Dose-Escalation Design
Biological: BI1206
375 mg/m2, as per SmPC
Other Name: Rituximab




Primary Outcome Measures :
  1. 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

  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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Up to 1 year ]
    Study the PK profile of Rituximab together with BI-1206

  5. Evaluation of ADA response to BI 1206 [ Time Frame: Up to 1 year ]
    Assess the immunogenicity of BI-1206

  6. Measurement of B cell depletion [ Time Frame: Up to 1 year ]
    Evaluate the effect of BI-1206

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571568


Contacts
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Contact: Marie Lindell Andersson +46708591816 marie.lindell.andersson@bioinvent.com

Locations
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United States, Georgia
Emory University Hospital Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Jonathon Cohen, MD         
Contact: Vanessa Smith, RN    (404)778-2419    vanessa.smith@emory.edu   
Poland
Szpital Specjlistyczny Not yet recruiting
Grudziadz, Poland, 86-300
Contact: Magdalena Korożan         
Małopolskie Centrum Medyczne Not yet recruiting
Krakow, Poland
Contact: Wojciech Jurczak, MD, PhD       Wjurczak.mcm@mp.pl   
Instytut Hematologii I Transfuzjologii, Klinika Hematologii Not yet recruiting
Warszawa, Poland, 02-776
Contact: Agnieszka Kołkowska- Leśniak, MD       agnieszka.kolkowska@poczta.fm   
Spain
Hospital ICO, Trias i Pujol Not yet recruiting
Badalona, Spain
Contact: Juan Manuel Sancho Cia, MD         
Hospital Duran i Reynals Av. Not yet recruiting
Barcelona, Spain
Contact: Santiago Mercadal Vilchez, MD         
Hospital Universitari Vall d'Hebron Not yet recruiting
Barcelona, Spain
Contact: Pablo Abrisqueta Costa, MD         
University Hospital Fundacion Jimenez Diaz Not yet recruiting
Madrid, Spain
Contact: Raul Cordoba Mascunano, MD         
Sweden
Department of Oncology, Skåne University Hospital Recruiting
Lund, Sweden, SE-22185
Contact: Mats Jerkeman, PI       mats.jerkeman@skane.se   
Principal Investigator: Mats Jerkeman, MD, PhD         
Department of Oncology, Academical Hospital Recruiting
Uppsala, Sweden, 751 85
Contact: Hans Hagberg, MD    +46 18 617 24 28    hans.hagberg@akademiska.se   
Sponsors and Collaborators
BioInvent International AB
Investigators
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Principal Investigator: Mats Jerkeman, MD PhD Senior Consultant and Adjunct Professor, Skane Univ Hospital, Lund, Sweden

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Responsible Party: BioInvent International AB
ClinicalTrials.gov Identifier: NCT03571568     History of Changes
Other Study ID Numbers: 17-BI1206-02
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
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
Clinical Study Report (CSR)
Time Frame: Within one year from end of study
Access Criteria: Paper copy of CSR

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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:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents