BGB-21447 for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: BeiGene

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 Expansion."

Research Team

Study Director

Principal Investigator

BeiGene

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• BGB-21447 (Bcl-2 Inhibitor)

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.

Participant Groups

Group I: Part 2 (Cohort A2): BGB-21447 Monotherapy Dose Expansion Experimental Treatment 1 Intervention

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

Group II: 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 III: 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+