Overview
This study is 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 (MTD), maximum administered dose (MAD), recommended Phase 2 dose (RP2D), and pharmacokinetic profile of the drug. Additionally, preliminary antitumor activity will be characterized. The study is divided into 2 main parts: Part 1 "Monotherapy Dose Finding" and Part 2 "Monotherapy Dose Optimization."
Principal investigator
Eligibility criteria
* High-grade B-cell lymphomas with translocations of MYC and Bcl-2 and/or Bcl-6 are not allowed in Cohort A1 but may be allowed in Cohort A2.1 2. R/R FL (for Cohort A1 and Cohort A2.2) 3. R/R MZL (for Cohort A1 and Cohort A2.2) 4. Transformed B-cell NHL (for Cohort A1 only) 5. Richter's transformation to DLBCL (for Cohort A1 only) 2. Measurable disease by computed tomography/magnetic resonance imaging.
Exclusion Criteria: 1. 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 or lentigo maligna melanoma that has been curatively resected 2. Known central nervous system involvement by lymphoma/leukemia 3. 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 4. Prior allogeneic stem cell transplant. 5. Major surgery \< 4 weeks before the first dose of study treatment NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
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