AzTrials
AzTrials

Indolent B-Cell Non-Hodgkin LymphomaPhase 1/2NCT03571568

A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL

A Phase 1/2 study testing BI-1206, Rituximab and Acalabrutinib in people with Indolent B-Cell Non-Hodgkin Lymphoma, run by BioInvent International AB at 27 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Indolent B-Cell Non-Hodgkin Lymphoma
What is being tested?
BI-1206, Rituximab and Acalabrutinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
27 sitesin 6 countries
Study dates
16 May 2018to 30 Sep 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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 FL grade 3B,
  • Need systemic doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the study trial other than as pre-medication.
Show all 21Show fewer
  • 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
  • Previous lines of treatment containing BTK inhibitors for Subjects receiving BI-1206 in combination with rituximab and acalabrutinib
  • 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

Trial locations and contacts

27 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Erika Bågeman contact

+46706126618

erika.bageman@bioinvent.com

Andres McAllister, MD, PhD contact

andres.mcallister@bioinvent.com

27 sites in 6 countries

Brazil10 sites, 10 recruiting

  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

    Curitiba

    munhoz.ec@gmail.com

    Eduardo Munhoz, MD

    Not yet recruiting

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

    Suellen, fogliattopesquisa@gmail.com

    Laura Maria Fogliatto, MD

    Recruiting

  • Ruschel Medicina e Pesquisa Clínica

    Rio de Janeiro

    Thaiane Alexandre, RN, thaianealexandre@ruschelmedicina.com.br

    Rony Schaffel, MD

    Not yet recruiting

  • Hospital São Rafael

    Salvador, Estado de Bahia

    Cacilda, analuziaschriefer@gmail.com

    Ana Luiza Schriefer, MD

    Recruiting

  • A.C. Camargo Cancer Center

    São Paulo

    ana.cordeiro@accamargo.org.br

    Ana Costa Cordeiro, MD

    Recruiting

  • Hospital Amaral Carvalho

    São Paulo

    pesquisafac.edersonmattos@gmail.com

    Ederson Roberto De Mattos, MD

    Not yet recruiting

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo

    Camila Hinsching, RN, camila.f@hc.fm.usp.br

    Juliana Pereira, MD

    Not yet recruiting

  • Hospital Israelita Albert Einstein

    São Paulo

    guiperini@gmail.com

    Guilherme Perini, MD

    Recruiting

  • Hospital Samaritano

    São Paulo

    carlos.chiattone@terra.com.br

    Carlos Chiattone, MD

    Not yet recruiting

  • Hospital Sírio-Libanês

    São Paulo

    anaritafonsecabm@gmail.com

    Ana Rita Da Fonseca, MD

    Not yet recruiting

Other trials in Brazil

Spain9 sites, 9 recruiting

  • Hospital ICO, Trias i Pujol

    Badalona, Barcelona

    jsancho@iconcologia.net

    Juan Manuel Sancho Cia, MA

    Recruiting

  • Hospital de la Santa Creu i Sant Pau, Dep Hematologia

    Barcelona, Barcelona

    smiqueleiz@santpau.cat

    Sara Miqueleiz Alamos, MD

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona

    pabrisqueta@vhio.net

    Pablo Abrisqueta Costa, MD

    Recruiting

  • Institut Català d'Oncologia, L'Hospitalet de Llobregat

    Barcelona

    edomingo@iconcologia.net

    Eva Domingo Domenech, MD

    Recruiting

  • Hospital General Universitario Gregorio Marañon-Oncología Médica

    Madrid, Madrid

    bastosmariana@yahoo.com

    Mariana Bastos Oreiro, MD

    Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid, Madrid

    Agustín Penedo Coello, apenedo@hmhospitales.com

    Augustin Penedo Coello, MD

    Recruiting

  • University Hospital Fundacion Jimenez Diaz

    Madrid

    raul.cordoba@fjd.es

    Raul Cordoba Mascunano, MD

    Recruiting

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, Murcia

    joaquingomezespuch@hotmail.com

    Joaquin Gomez Espuch, MD

    Not yet recruiting

  • Hospital University Virgen Macarene

    Seville, Seville

    Sergio Ortegón Alcaide, sortegonalcaide@gmail.com

    Sergio Ortegon Alcaide, MD

    Recruiting

Other trials in Spain

United States2 sites, 1 recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Active, not recruiting

  • Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405

    Louisville, Kentucky, 40207

    Don Stevens, MD

    Recruiting

Other trials in United States

Germany2 sites, 1 recruiting

  • Krankenhaus Nordwest Klinik für Onkologie und Hämatologie

    Frankfurt am Main, Hesse

    weidmann.eckhart@khnw.de

    Eckhart Weidmann, MD

    Not yet recruiting

  • Robert Bosch Hospital, Dep of Hematology, Oncology and Palliative care

    Stuttgart

    Withdrawn

Other trials in Germany

Poland2 sites

  • Szpital Specjlistyczny

    Grudziądz, 86-300

    Terminated

  • Małopolskie Centrum Medyczne

    Krakow

    Terminated

Other trials in Poland

Sweden2 sites

  • Department of Oncology, Skåne University Hospital

    Lund, SE-22185

    Terminated

  • Department of Oncology, Academical Hospital

    Uppsala, Sweden, 751 85

    Terminated

Other trials in Sweden

About this study

Official title: Phase 1/2a Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab

Read the detailed description

This is a Phase 1/2a, multicenter, dose escalation, consecutive-cohort, open-label trial of BI-1206 in combination with rituximab with or without acalabrutinib in subjects with indolent relapsed or refractory B-cell NHL, sub-types FL (except FL grade 3B), MZL, and MCL.

Phase 2a, consists of signal seeking cohorts followed by a randomized, parallel, two-arm dose optimization.

The trial consists of 2 main parts:

Phase 1

  • Dose Escalation, with two different Arms assessing IV or SC dosing of BI-1206 in combination with rituximab, with dose escalation cohorts and selection of the IV and SC doses of BI-1206 for Phase 2a

Phase 2a

  • Dose Expansion, with one expansion cohort evaluating the selected IV dose of BI-1206 in combination with rituximab
  • Signal Seeking, assessing IV and SC dosing of BI-1206 in combination with rituximab and acalabrutinib. The Signal Seeking will consist of a Safety Run-in and an Expansion
  • Dose Optimization to select the recommended dose of BI-1206 in combination with rituximab and acalabrutinib
Being tested
BI-1206, Rituximab, Acalabrutinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI-1206Biological

    BI-1206 150 mg / 225 mg Subcutaneous injection

    BI-1206 50 mg /100 mg Intravenous infusion

  • RituximabBiological

    Also called Ruxience

    Rituximab 375 mg/m2, as per SmPC

  • AcalabrutinibBiological

    Also called Calquence

    Acalabrutinib 100 mg orally as per SmPC

Study groups in NCT03571568
Study groupRoleWhat they receive
BI-1206 IV Dose EscalationExperimentalStandard 3+3 Dose-Escalation of BI-1206 IV in combination with Rituximab
Receives: Biological: BI-1206; Biological: Rituximab
BI-1206 SC Dose EscalationExperimentalAdaptive Dose Escalation of BI-1206 SC (Bayesian logistic regression model (BLRM) in combination with Rituximab
Receives: Biological: BI-1206; Biological: Rituximab
Phase 2a IV Dose expansionExperimentalBI-1206 IV in Combination with Rituximab
Receives: Biological: BI-1206; Biological: Rituximab
Phase 2a SC Signal seekingExperimentalSC Arm, BI-1206 in Combination with Rituximab and Acalabrutinib
Receives: Biological: BI-1206; Biological: Rituximab; Biological: Acalabrutinib
Phase 2a IV Signal SeekingExperimentalIV Arm, BI-1206 in Combination with Rituximab and Acalabrutinib
Receives: Biological: BI-1206; Biological: Rituximab; Biological: Acalabrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab and/or acalabrutinib

    Assess the safety and tolerability profile of BI-1206 when administered intravenously (IV) or subcutaneously (SC) in combination with rituximab or rituximab and acalabrutinib in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL), subtypes follicular lymphoma (FL)(except FL grade 3B), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL). Assessment will be done according to National Cancer Institute (NCI-CTCAE) criteria v. 5.0.

    Measured: During the 28-day treatment period on induction therapy

  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)

    Phase 1:

    Select the recommended Phase 2 dose (RP2D) by establishing the maximum tolerated dose (MTD) of BI-1206 given once weekly for 4 weeks, via IV infusion or SC injection in combination with rituximab.

    Measured: During the 28-day treatment period on induction therapy

  3. Determine the recommended dose of BI-1206 in combination with rituximab and acalabrutinib

    Phase 2a:

    Select the recommended dose of BI-1206 in combination with rituximab and acalabrutinib.

    Measured: During the 28-day treatment period on induction therapy

Secondary outcomes (4)

  1. Evaluation of PK parameters for BI-1206

    PK parameters assessed will include AUC, Cmax, time to Cmax and t1/2 of BI-1206 when administered IV or SC

    Measured: Up to 1 year

  2. Evaluation of ADA (immunogenicity) response to BI-1206

    Assess the incidence and titre of antidrug antibodies of BI-1206 in serum when administered IV or SC in combination with rituximab or rituximab and acalabrutinib.

    Measured: Up to 1 year

  3. Measurement of peripheral blood B-lymphocytes depletion

    Evaluate the effect of BI-1206 administered IV or SC in combination with rituximab or rituximab and acalabrutinib measuring B Lymphocytes CD19+ (absolute value) as part of hematology assessment to determine the level of peripheral blood B lymphocyte depletion.

    Measured: Up to 1 year

  4. Assessment of overall response rate (ORR) according to the response criteria for malignant lymphoma (Cheson, 2014).

    Assess possible anti-tumor activity of BI-1206 administered IV or SC in combination with rituximab or rituximab and acalabrutinib at Week 6 after first dose of BI-1206 and for subjects who continue during maintenance therapy.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2018
  2. Study start16 May 2018
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Phase 1/2a, dose escalation, consecutive-cohort, open-label study trial of BI-1206 in combination with rituximab with or without Acalabrutinib
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03571568
Sponsor's protocol ID
17-BI-1206-02
Status last verified
Oct 2026
First submitted
17 May 2018
Last updated
2 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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 study and for no other purpose unless prior written permission from the Sponsor is obtained.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BI-1206, Rituximab and Acalabrutinib in people with Indolent B-Cell Non-Hodgkin Lymphoma, run by BioInvent International AB at 27 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Brazil, Spain, United States, Germany, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erika Bågeman (+46706126618, erika.bageman@bioinvent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab and/or acalabrutinib (time frame: During the 28-day treatment period on induction therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03571568.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in