For Healthcare Professionals

A Study of BI-1206 in Combination With Rituximab in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma

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About the study

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab
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Who can take part

You may be eligible to participate in the study if you meet the following 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 FL3B), MCL and marginal zone lymphoma (MZL).
  3. Have measureable 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 FL3B,
  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 the following:
  10. Chemotherapy or small molecule products with 2 weeks of first dose of BI-1206
  11. Radiotherapy (except for focal symptomatic control of lymphadenopathy) within 4 weeks
  12. Immunotherapy within 8 weeks
  13. Have ongoing toxic manifestations of previous treatments.
  14. Have the ability to become pregnant (or already pregnant or lactating/breastfeeding).
  15. Have had major surgery from which the subject has not yet recovered.
  16. Are at high medical risk because of non-malignant systemic disease including active infection on treatment with antibiotics, antifungals or antivirals.
  17. Are serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
  18. Have an active, known or suspected autoimmune disease.
  19. Have concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA]),
  20. Have current malignancies of other types
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +46708429773Email iconEmail Study Center

Study’s details


Contition

Indolent B-Cell Non-Hodgkin Lymphoma

Age

18+

Phase

Phase 1/Phase 2

Participants needed

30

Est. Completion Date

Dec 2023

Treatment type

Interventional


Sponsor

BioInvent International AB

ClinicalTrials.gov identifier

NCT03571568

Study number

17-BI-1206-02

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