Clinical trial · Interventional
A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies
A Phase 1/1b Open-Label Dose-Escalation and Dose-Optimization Study of Bcl-2 Inhibitor BGB-21447 in Patients With Mature B-Cell Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This decision is due to a company business decision with strategy change on the BGB-21447 development in B-cell malignancies and is not driven by safety concerns.
Summary
Brief summary (as posted)
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."
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Refractory Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Refractory Follicular Lymphoma | Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Marginal Zone Lymphoma | Marginal Zone Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | CURATED_BROADER | 0.78 |
| Relapsed Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BGB-21447 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1 (Cohort A1): Dose escalation in patients with B-cell non-Hodgkin lymphoma (NHL)
- description
- Participants with R/R B-cell NHL (including diffuse large B-cell lymphoma \[DLBCL\], follicular lymphoma \[FL\], marginal zone lymphoma \[MZL\], transformed B-cell NHL (B-NHL), and Richter's transformation to DLBCL) will receive BGB-21447 once a day.
- interventionNames
- Drug: BGB-21447
- type
- EXPERIMENTAL
- label
- Part 1 (Cohort B): Dose escalation in R/R CLL/SLL participants with low tumor burden
- description
- Participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) will receive BGB-21447 once a day.
- interventionNames
- Drug: BGB-21447
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (0)
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