A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies

Launched by BEIGENE · Apr 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called BGB-21447, which is designed to help people with certain types of cancer affecting B-cells, such as non-Hodgkin lymphoma and chronic lymphocytic leukemia. The main goal of the study is to find out how safe the drug is, how much of it can be given to patients, and if it has any effects on shrinking tumors. The trial is divided into two parts: the first part focuses on finding the right dose, while the second part looks at how well the drug works at that dose.

To participate in this trial, individuals must be between 65 and 74 years old and have been diagnosed with specific types of relapsed or refractory non-Hodgkin lymphoma or chronic lymphocytic leukemia. They should have measurable disease, which means the cancer can be tracked using imaging tests like CT scans. However, there are some exclusions, such as having another recent cancer diagnosis or certain treatments in the past few months. If eligible, participants can expect regular check-ups and monitoring while taking the medication, helping researchers understand the drug's effects and potential benefits.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• 1. Confirmed diagnosis (per World Health Organization \[WHO\] guidelines, unless otherwise noted) of one of the following:
• Cohort A1 and Cohort A2:
• • 1. R/R DLBCL (for Cohort A1 and Cohort A2.1)
• • 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.