Non Hodgkin Lymphoma Clinical Trial

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

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

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Full Description

This is a Phase 1/2a, dose escalation, consecutive-cohort, open-label trial of BI-1206 in combination with rituximab in subjects with indolent relapsed or refractory B-cell NHL, subtypes FL (except FL grade 3B), MZL, and MCL.

The trial consists of 2 main parts:

Phase 1 with two different Arms assessing IV or SC dosing of BI-1206,with dose escalation cohorts and selection of the RP2D of IV dosing (ivRP2D)and the RP2D of SC dosing (scRP2D) of BI-1206 in combination with rituximab (administered IV).
Phase 2a with two expansion cohorts evaluating the ivRP2D and scRP2D of BI-1206 in combination with rituximab (administered IV).

Subjects in each phase (Phase 1 and 2a) and dosing Arms will receive 1 cycle 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 ( using the same dose and route of administration as induction therapy) 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).

View Eligibility Criteria

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 FL grade 3B), MCL and marginal zone lymphoma (MZL).
Have measurable 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 any of 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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

98

Study ID:

NCT03571568

Recruitment Status:

Recruiting

Sponsor:

BioInvent International AB

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There are 5 Locations for this study

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Emory University Hospital
Atlanta Georgia, 30322, United States More Info
Jonathon Cohen, MD
Contact
Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405
Louisville Kentucky, 40207, United States More Info
Don Stevens, MD
Contact
Krankenhaus Nordwest Klinik für Onkologie und Hämatologie
Frankfurt , , Germany More Info
Eckhart Weidmann, MD
Contact
Robert Bosch Hospital, Dep of Hematology, Oncology and Palliative care
Stuttgart , , Germany More Info
Nicola Giesen, MD
Contact
Szpital Specjlistyczny
Grudziadz , 86-30, Poland
Małopolskie Centrum Medyczne
Krakow , , Poland
Hospital ICO, Trias i Pujol
Badalona , , Spain More Info
Juan Manuel Sancho Cia, MD
Contact
Hospital de la Santa Creu i Sant Pau, Dep Hematologia
Barcelona , , Spain More Info
Silvana Novelli, MD
Contact
Hospital Universitari Vall d'Hebron
Barcelona , , Spain More Info
Pablo Abrisqueta Costa, MD
Contact
Institut Català d'Oncologia, L'Hospitalet de Llobregat
Barcelona , , Spain More Info
Eva Domingo Domenech, MD
Contact
Hospital General Universitario Gregorio Marañon-Oncología Médica
Madrid , , Spain More Info
Mariana Bastos Oreiro, MD
Contact
Hospital Universitario HM San Chinarro
Madrid , , Spain More Info
Jaime Perez de Oteyza, MD
Contact
University Hospital Fundacion Jimenez Diaz
Madrid , , Spain More Info
Raul Cordoba Mascunano, MD
Contact
Hospital Universitario Virgen de la Arrixaca
Murcia , , Spain More Info
Joaquin Gomez Espuch, MD
Contact
Hospital Virgen Macarene
Seville , , Spain More Info
Isabel Fernández Román, MD
Contact
Department of Oncology, Skåne University Hospital
Lund , SE-22, Sweden More Info
Mats Jerkeman, PI
Contact
Mats Jerkeman, MD, PhD
Principal Investigator
Department of Oncology, Academical Hospital
Uppsala , 751 8, Sweden

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

98

Study ID:

NCT03571568

Recruitment Status:

Recruiting

Sponsor:


BioInvent International AB

How clear is this clinincal trial information?

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