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

Description

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

Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Relapsed Follicular Lymphoma, Relapsed Marginal Zone Lymphoma, Relapse Diffuse Large B Cell Lymphoma, Relapsed Small Lymphocytic Lymphoma, Refractory Follicular Lymphoma, Refractory Marginal Zone Lymphoma, Refractory Small Lymphocytic Lymphoma, Richter Transformation, Refractory Diffuse Large B-cell Lymphoma, Transformed Non-Hodgkin Lymphoma

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Study Overview

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Study Details

Study overview

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."

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

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

Condition
Relapsed Non-Hodgkin Lymphoma
Intervention / Treatment

-

Contacts and Locations

Waukee

Mission Cancer and Blood, Waukee, Iowa, United States, 50263

Baltimore

Sidney Kimmel Comprehensive Cancer At Johns Hopkins, Baltimore, Maryland, United States, 21287

Philadelphia

Thomas Jefferson University, Philadelphia, Pennsylvania, United States, 19107-4216

Sioux Falls

Avera Cancer Institue, Sioux Falls, South Dakota, United States, 57105-2108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

2027-04