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

Cancer Type
Hematopoietic Malignancies
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase I
Phase II
18 Years and older, Male and Female
Study Type
Protocol IDs
17-BI1206-02 (primary)
Study Sponsor
BioInvent International AB


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


This is a Phase 1/2a, dose escalation, consecutive-cohort, open-label trial of BI-1206 in
combination with rituximab in subjects with indolent relapsed or refractory B-cell NHL,
subtypes FL (except FL grade 3B), MZL, and MCL.

The trial consists of 2 main parts:

- Phase 1 with two different Arms assessing IV or SC dosing of BI-1206,with dose
escalation cohorts and selection of the RP2D of IV dosing (ivRP2D)and the RP2D of SC
dosing (scRP2D) of BI-1206 in combination with rituximab (administered IV).

- Phase 2a with two expansion cohorts evaluating the ivRP2D and scRP2D of BI-1206 in
combination with rituximab (administered IV).

Subjects in each phase (Phase 1 and 2a) and dosing Arms will receive 1 cycle of induction
therapy with BI-1206 in combination with rituximab.

Subjects who show clinical benefit (complete response [CR], partial response [PR], or
stable disease [SD]) at Week 6 will continue onto maintenance therapy and receive BI-1206
( using the same dose and route of administration as induction therapy) and rituximab
once every 8 weeks (relative to previous maintenance dose) for up to 6 maintenance
cycles, or up to 1 year from first dose of BI-1206 (whichever occurs first).


  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

Treatment Sites in Georgia

Emory University Hospital - Atlanta

1364 Clifton Road NE
Atlanta, GA 30322

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.