Phase 1 Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies
Relapsed Non-Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
Relapsed Chronic Lymphocytic Leukemia
Refractory Chronic Lymphocytic Leukemia
Relapsed Follicular Lymphoma
Relapsed Marginal Zone Lymphoma
Diffuse Large B Cell Lymphoma
Relapsed Small Lymphocytic Lymphoma
Refractory Follicular Lymphoma
Refractory Marginal Zone Lymphoma
Refractory Small Lymphocytic Lymphoma
This is a Phase 1 study testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose, recommended Phase 2 dose, and pharmacokinetic profile of the drug. Additionally, preliminary antitumor activity will be characterized. The study includes three cohorts and will also evaluate the safety and tolerability of a ramp-up dosing schedule.
|Ages Eligible for Study:
|18 Years and older (Adult, Older Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
1. Confirmed diagnosis per WHO guidelines of one of the following:
- Relapsed/refractory (R/R) Diffuse large B-cell lymphoma (DLBCL)(excluding high-grade B-cell lymphomas with translocations of MYC and Bcl-6 and/or Bcl-2; primary cutaneous DLBCL, leg type; gray zone lymphoma; and primary mediastinal large B-cell lymphoma)
- R/R Follicular lymphoma (FL):
- R/R Marginal zone lymphoma (MZL
- Transformed B-Cell non-Hodgkin lymphoma (NHL)
Cohorts B and C:
- R/R CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
- Measurable disease by computed tomography (CT) and/or magnetic resonance imaging (MRI).
- Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer
- Known central nervous system involvement by lymphoma/leukemia
- Known history or currently suspected Richter’s syndrome
- Prior autologous stem cell transplant < 3 months before the first dose of study drug. Or prior chimeric antigen receptor T-cell (CAR-T) therapy < 3 months before the first dose of study drug
- Prior allogeneic stem cell transplant.
- Major surgery < 4 weeks before the first dose of study treatment
Use of the following substances prior to the first dose of the study drug:
- Any biologic and/or immunologic-based therapy(ies) ≤ 28 days before the first dose of study drug
- Any systemic chemotherapy or radiation therapy ≤ 14 days before the first dose of study drug
- Any targeted small molecule agents ≤ 14 days before the first dose of study drug
- Corticosteroid given with antineoplastic intent ≤ 7 days before the first dose of study drug. Short course of systemic corticosteroid treatment for control of lymphomarelated symptoms is allowed prior to enrollment, provided it is tapered off within 5 days after initiation of study treatment.
- Any treatment with a strong/moderate cytochrome P450 (CYP)3A inhibitor or inducer ≤ 14 days (or 5 half-lives for inhibitors, whichever is longer) before the first dose of study drug OR requiring long-term use of strong CYP3A inhibitors or inducers
NOTE: Other Inclusion/Exclusion criteria may apply.
Prof. Chan Cheah