Recruiting
Phase 1
Phase 2

BI-1206 & Rituximab, Acalabrutinib

Sponsor:

BioInvent International AB

Code:

NCT03571568

Conditions

Indolent B-Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BI-1206

Rituximab

Acalabrutinib

Study Details

Brief 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

Conditions

Indolent B-Cell Non-Hodgkin Lymphoma

Study ID

NCT03571568

Start date

May 16, 2018

Status verified date

Apr, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BI-1206 IV Dose Escalation

Standard 3+3 Dose-Escalation of BI-1206 IV in combination with Rituximab

experimental: BI-1206 SC Dose Escalation

Adaptive Dose Escalation of BI-1206 SC (Bayesian logistic regression model (BLRM) in combination with Rituximab

experimental: Phase 2a IV Dose expansion

BI-1206 IV in Combination with Rituximab

experimental: Phase 2a SC Signal seeking

SC Arm, BI-1206 in Combination with Rituximab and Acalabrutinib

experimental: Phase 2a IV Signal Seeking

IV Arm, BI-1206 in Combination with Rituximab and Acalabrutinib

Interventions

BI-1206

BI-1206 150 mg / 225 mg Subcutaneous injection

BI-1206 50 mg /100 mg Intravenous infusion

Rituximab

Rituximab 375 mg/m2, as per SmPC

Acalabrutinib

Acalabrutinib 100 mg orally as per SmPC

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 ]
  • 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) [ Time Frame: During the 28-day treatment period on induction therapy ]
  • Determine the recommended dose of BI-1206 in combination with rituximab and acalabrutinib [ Time Frame: During the 28-day treatment period on induction therapy ]

Central Contacts and Locations

Central contacts

Locations

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

Recruiting

Louisville, Kentucky, United States, 40207

Principal Investigator:

Don Stevens, MD

More Information

Sponsor

BioInvent International AB

Last update posted

Apr 24, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BioInvent International AB on 2025-04-24.