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Combination treatment for indolent B-cell non-Hodgkin lymphoma

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

Phase1; Phase2 Interventional BioInvent International AB · NCT03571568

This study is testing a new combination of treatments for people with indolent B-cell non-Hodgkin lymphoma that hasn't responded to previous therapies to see if it can help them.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment140 (estimated)
Ages18 Years and up
SexAll
SponsorBioInvent International AB Industry-sponsored
Drugs / interventionsrituximab, acalabrutinib, Chemotherapy, Immunotherapy
Locations27 sites (Atlanta, Georgia and 26 other locations)
Trial IDNCT03571568 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of BI-1206, a monoclonal antibody, in combination with rituximab, with or without acalabrutinib, for patients with indolent B-cell non-Hodgkin lymphoma that has relapsed or is refractory to previous treatments. The trial is divided into two phases: Phase 1 focuses on dose escalation to determine the optimal dosing of BI-1206, while Phase 2a includes dose expansion and optimization based on the findings from Phase 1. Participants will be monitored for treatment response and safety throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory indolent B-cell non-Hodgkin lymphoma who have previously received at least one rituximab-based therapy.

Not a fit: Patients who have had an allogenic bone marrow or stem cell transplant within the last 12 months or have active chronic graft versus host disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat indolent B-cell non-Hodgkin lymphoma.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating B-cell non-Hodgkin lymphoma, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Atlanta, Georgia and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Indolent B-Cell Non-Hodgkin Lymphoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.