BGB-21447 for Non-Hodgkin's Lymphoma

Not currently recruiting at 41 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BeiGene

Disqualifiers: Prior malignancy, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BGB-21447 for individuals with specific types of non-Hodgkin's lymphoma and chronic lymphocytic leukemia that have returned or resisted previous treatments. The main goal is to assess the safety and tolerability of BGB-21447 while determining the optimal dose for future studies. Individuals with a confirmed diagnosis of relapsed or refractory non-Hodgkin's lymphoma, such as diffuse large B-cell lymphoma or follicular lymphoma, and a measurable disease may qualify for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that BGB-21447 is likely to be safe for humans?

Research shows that BGB-21447 is being tested for safety and tolerance in people with relapsed or refractory non-Hodgkin's lymphoma and chronic lymphocytic leukemia. This trial is in an early stage, focusing on assessing the treatment's safety and potential side effects.

Due to the trial's early stage, limited information exists about its safety in humans. However, these trials are specifically designed to evaluate how well participants tolerate the treatment. Currently, no specific information is available about side effects or safety issues for BGB-21447. Researchers closely monitor participants to address any problems promptly.

Prospective participants should ask the research team about any known side effects from earlier studies and the safety measures in place. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for non-Hodgkin's lymphoma, which often include chemotherapy, targeted therapies, and immunotherapy, BGB-21447 offers a different approach by focusing on dose optimization for relapsed or refractory types. Researchers are excited about this treatment because it targets specific pathways in B-cell non-Hodgkin lymphoma, potentially enhancing safety and efficacy. Additionally, BGB-21447's unique mechanism may provide better outcomes for patients with lower tumor burdens, offering a tailored approach to treatment.

What evidence suggests that BGB-21447 might be an effective treatment for non-Hodgkin's lymphoma?

Research shows that BGB-21447 is a Bcl-2 inhibitor, a type of drug that targets a protein aiding cancer cell survival. By blocking this protein, the drug makes it harder for cancer cells to persist. Early studies of similar drugs have shown promise in treating certain types of B-cell non-Hodgkin's lymphoma (NHL), such as diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and marginal zone lymphoma (MZL), which are common forms of NHL. In this trial, participants will receive BGB-21447 in different cohorts to evaluate its safety and efficacy across various types of relapsed/refractory B-cell NHL. While specific data on BGB-21447 is still being collected, Bcl-2 inhibitors like it are well-known for targeting these cancer types. ^{3 4 6 7 8}

Who Is on the Research Team?

Study Director

Principal Investigator

BeiGene

Are You a Good Fit for This Trial?

This trial is for people with certain types of blood cancers, like various forms of non-Hodgkin lymphoma and chronic lymphocytic leukemia that have come back or didn't respond to treatment. Participants must have a measurable disease confirmed by scans. It's not open to individuals who don't meet these specific cancer criteria.

Inclusion Criteria

My condition is relapsed or refractory diffuse large B-cell lymphoma.

My condition is relapsed or refractory follicular lymphoma.

My condition has progressed to diffuse large B-cell lymphoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monotherapy Dose Finding

Participants receive BGB-21447 to determine the maximum tolerated dose, maximum administered dose, and recommended Phase 2 dose

Up to approximately 1 month

Monotherapy Dose Expansion

Further evaluation of safety and efficacy of BGB-21447 with up to two dose levels from Cohort A1

Up to approximately 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 24 months

What Are the Treatments Tested in This Trial?

Interventions

• BGB-21447

Trial Overview The study tests BGB-21447, which targets a protein in cancer cells, on its own (monotherapy) in patients whose blood cancer has returned or resisted previous treatments. The goal is to find the safest dose that works best and see how the body processes the drug while also checking its effect on tumors.

How Is the Trial Designed?

Group I: Part 2 (Cohort A2.2): BGB-21447 Monotherapy Dose Optimization in R/R FL or R/R MZL Experimental Treatment 1 Intervention

Participants will receive BGB-21447 with two dose levels from Cohort A1 for further evaluation of safety and efficacy.

Group II: Part 2 (Cohort A2.1): BGB-21447 Monotherapy Dose Optimization in R/R DLBCL Experimental Treatment 1 Intervention

Participants will receive BGB-21447 with two dose levels from Cohort A1 for further evaluation of safety and efficacy.

Group III: Part 1 (Cohort B): Dose escalation in R/R CLL/SLL participants with low tumor burden Experimental Treatment 1 Intervention

Participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) will receive BGB-21447 once a day.

Group IV: Part 1 (Cohort A1): Dose escalation in patients with B-cell non-Hodgkin lymphoma (NHL) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/show/NCT05828589

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

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11720094/

Updates in the Management of Richter Transformation - PMC Simple Summary. Richter transformation (RT) describes a rare progression of chronic lymphocytic leukemia (CLL) to an aggressive lymphoma.

3. cancer.org cancer.org/cancer/types/non-hodgkin-lymphoma/about/b-cell-lymphoma.html

Types of B-cell Lymphoma B-cell lymphomas make up most (about 85%) of the non-Hodgkin lymphomas (NHL) in the United States. These types of lymphomas start in early ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557796/

Diffuse Large B-Cell Lymphoma - StatPearls - NCBI Bookshelf Diffuse large B cell lymphoma (DLBCL) is the most common lymphoma, accounting for about 25% to 30% of all the non-Hodgkin lymphomas. It typically presents as a ...

5. ashpublications.org ashpublications.org/blood/article/146/2/145/536677/Doubling-down-the-new-deal-in-the-clinical

the new deal in the clinical management of double-refractory ... Targeted therapy with covalent Bruton tyrosine kinase inhibitors (cBTKis) and/or the B-cell lymphoma 2 inhibitor (BCL-2i) venetoclax is now well established.

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/411775

A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell ... This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL)

7. withpower.com withpower.com/trial/bgb-21447-for-non-hodgkins-lymphoma-665b8

BGB-21447 for Non-Hodgkin's Lymphoma 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 ...

8. sigma.larvol.com sigma.larvol.com/disease.php?e1=8299&e2=&DiseaseId=8299&tab=DiseaseOTT&sr=now&er=1+month&ipwnd=on&rlink=,DiseaseId=8299,tab=DiseaseOTT&rflag=1&page=10

Diffuse Large B Cell Lymphoma Trials BGB-21447. BeiGene. Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic ...