A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies (NCT05828589) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies
United States112 participantsStarted 2023-06-20
Plain-language summary
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."
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Confirmed diagnosis (per World Health Organization \[WHO\] guidelines, unless otherwise noted) of one of the following:
✓. R/R DLBCL (for Cohort A1 and Cohort A2.1)
✓. R/R FL (for Cohort A1 and Cohort A2.2)
✓. R/R MZL (for Cohort A1 and Cohort A2.2)
✓. Transformed B-cell NHL (for Cohort A1 only)
✓. Richter's transformation to DLBCL (for Cohort A1 only)
✓. Measurable disease by computed tomography/magnetic resonance imaging.
Exclusion criteria
✕. 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
✕. Known central nervous system involvement by lymphoma/leukemia
What they're measuring
1
Part 1: Number of participants with dose limiting toxicities (DLTs)
Timeframe: Up to approximately 1 month
2
Number of participants with adverse events (AEs)
Timeframe: From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurs first; up to approximately 12 months
3
Number of participants with Tumor Lysis Syndrome (TLS)
Timeframe: From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurs first; up to approximately 12 months
✕. 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