RecruitingPhase 1/2

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

United States, Brazil, Germany140 participantsStarted 2018-05-16

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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)

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

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

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

Trial details

NCT IDNCT03571568

SponsorBioInvent International AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Erika Bågeman

+46706126618 erika.bageman@bioinvent.com

View on ClinicalTrials.gov More Indolent B-Cell Non-Hodgkin Lymphoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

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

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)

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

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

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

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria