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New antibody combo aims to outsmart lymphoma that outlasted rituximab

NCT ID NCT03571568

Disease control Sponsor: BioInvent International AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 02, 2026 · Last updated Oct 02, 2026

Summary

Researchers are testing an experimental antibody called BI-1206 in adults whose indolent B-cell non-Hodgkin lymphoma has returned or stopped responding to rituximab. Participants receive BI-1206 with rituximab, and some also receive acalabrutinib. The trial's first goal is to find a safe dose and check side effects, then see whether the combination helps control the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI-1206, an experimental antibody given with rituximab and sometimes acalabrutinib
What this could lead to
If it works, this could offer a new combination option for people whose indolent B-cell lymphoma has come back after rituximab.
What could go wrong
This is an early-phase trial with about 140 participants, so researchers mainly check safety and dosing. The combination may not control the cancer, and side effects from the drugs or infusions are possible.
Why investors are watching

BioInvent International AB runs this Phase 1/2a trial of BI-1206, an antibody that targets CD32b, given with rituximab and optionally acalabrutinib to 140 people whose indolent B-cell non-Hodgkin lymphoma came back or stopped responding to rituximab. The trial tests whether blocking CD32b helps rituximab work in patients who have already failed it, a question that matters because a small company depends on a few programs for its future.

If it works: A positive result could support further development of BI-1206 and draw partner or investor interest in BioInvent's pipeline.

If it fails: A failure or delay could set back the program and strain a small company's resources, and most early-stage oncology trials do not produce the hoped-for result.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2018

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Are ≥ 18 years of age by initiation of study treatment. 2. 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) 3. Have measurable nodal disease 4. Are willing to undergo lymph node biopsies or biopsies of other involved tissue 5. Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists 6. Have received at least one line of conventional previous therapy which must include at least one rituximab-based regimen 7. Have a life expectancy of at least 12 weeks 8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 9. Have CD20+ malignancy 10. Have hematological and biochemical indices within prespecified ranges Exclusion Criteria: 1. Have had an allogenic bone marrow or stem cell transplant within 12 months 2. Have presence of active chronic graft versus host disease 3. Have current leptomeningeal lymphoma or compromise of the central nervous system 4. Have transformed lymphoma from a pre-existing indolent lymphoma 5. Have Waldenstrom's Macroglobulinemia or FL grade 3B, 6. Need systemic doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) while on the study trial other than as pre-medication. 7. Have known or suspected hypersensitivity to rituximab or BI-1206 8. Have cardiac or renal amyloid light-chain amyloidosis 9. Have received any of the following: 1. Chemotherapy or small molecule products with 2 weeks of first dose of BI-1206 2. Radiotherapy (except for focal symptomatic control of lymphadenopathy) within 4 weeks 3. Immunotherapy within 8 weeks 4. Previous lines of treatment containing BTK inhibitors for Subjects receiving BI-1206 in combination with rituximab and acalabrutinib 10. Have ongoing toxic manifestations of previous treatments. 11. Have the ability to become pregnant (or already pregnant or lactating/breastfeeding). 12. Have had major surgery from which the subject has not yet recovered. 13. Are at high medical risk because of non-malignant systemic disease including active infection on treatment with antibiotics, antifungals or antivirals. 14. Are serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV). 15. Have an active, known or suspected autoimmune disease. 16. Have concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association \[NYHA\]) 17. Have current malignancies of other types

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Conditions

The condition(s) this trial relates to.

follicular lymphoma indolent B-cell non-Hodgkin lymphoma mantle cell lymphoma marginal zone lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Indolent B-cell non-Hodgkin lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.C. Camargo Cancer Center

    RECRUITING

    São Paulo, Brazil

  • Department of Oncology, Academical Hospital

    TERMINATED

    Uppsala, Sweden, 751 85, Sweden

  • Department of Oncology, Skåne University Hospital

    TERMINATED

    Lund, SE-22185, Sweden

  • Emory University Hospital

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30322, United States

  • Hospital Amaral Carvalho

    NOT_YET_RECRUITING

    São Paulo, Brazil

  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

    NOT_YET_RECRUITING

    Curitiba, Brazil

  • Hospital General Universitario Gregorio Marañon-Oncología Médica

    RECRUITING

    Madrid, Madrid, Spain

  • Hospital ICO, Trias i Pujol

    RECRUITING

    Badalona, Barcelona, Spain

  • Hospital Israelita Albert Einstein

    RECRUITING

    São Paulo, Brazil

  • Hospital Samaritano

    NOT_YET_RECRUITING

    São Paulo, Brazil

  • Hospital São Rafael

    RECRUITING

    Salvador, Estado de Bahia, Brazil

  • Hospital Sírio-Libanês

    NOT_YET_RECRUITING

    São Paulo, Brazil

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Barcelona, Spain

  • Hospital Universitario HM Sanchinarro

    RECRUITING

    Madrid, Madrid, Spain

  • Hospital Universitario Virgen de la Arrixaca

    NOT_YET_RECRUITING

    Murcia, Murcia, Spain

  • Hospital University Virgen Macarene

    RECRUITING

    Seville, Seville, Spain

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

    NOT_YET_RECRUITING

    São Paulo, Brazil

  • Hospital de Clínicas de Porto Alegre

    RECRUITING

    Porto Alegre, Rio Grande do Sul, Brazil

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

    RECRUITING

    Barcelona, Barcelona, Spain

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

    RECRUITING

    Barcelona, Spain

  • Krankenhaus Nordwest Klinik für Onkologie und Hämatologie

    NOT_YET_RECRUITING

    Frankfurt am Main, Hesse, Germany

  • Małopolskie Centrum Medyczne

    TERMINATED

    Krakow, Poland

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

    RECRUITING

    Louisville, Kentucky, 40207, United States

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

    WITHDRAWN

    Stuttgart, Germany

  • Ruschel Medicina e Pesquisa Clínica

    NOT_YET_RECRUITING

    Rio de Janeiro, Brazil

  • Szpital Specjlistyczny

    TERMINATED

    Grudziądz, 86-300, Poland

  • University Hospital Fundacion Jimenez Diaz

    RECRUITING

    Madrid, Spain

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