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Trial Acronym
BGB-21447-101
Registration Number
NCT05828589
Scientific Title
A Phase 1/1b Open-Label Dose-Escalation Study of Bcl-2 Inhibitor BGB-21447 in Patients With Mature B-Cell Malignancies
Brief Summary
Key Inclusion Criteria
Key Exclusion Criteria
Trial Locations
Primary Sponsor
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 adminstered 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."
1.Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following: Cohort A1 and Cohort A2: R/R DLBCL R/R FL R/R MZL Transformed B-cell NHL Richter's transformation to DLBCL 2. Measurable disease by computed tomography/magnetic resonance imaging.
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 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
Trial Location Name
Address
Status
Blacktown Hospital (Haematology)
18 Blacktown Rd, Blacktown NSW 2148, Australia
Recruiting
Primary Contact :
Bonawentura Treder,
Bonawentura.Treder@health.nsw.gov.au
, 0424 001 880
BeiGene
Website URL
Link Name
Link URL
N/A
N/A
Secondary IDs
N/A
Study Type
Interventional
Intervention Code
Treatment - Drugs
Phase
Phase 1
Minimum Age
18
Maximum Age
100
Date Registered
14/08/2024
Date Closed
N/A
Status
Open
Enrolment Type
By Specialist and/or Surgeon Referral
Mutation Status and Biomarker
N/A
Is it a Cohort Trial?
No
Is this a Tele-Trial?
No
Can healthy volunteer participate?
No
Discipline
Health Condition
Category
Sub Category
Haematology
Lymphoma B-Cell Non Hodgkin
Small Cell (SLL)
Relapsed/Refractory
Myelodysplastic Disorders (MDS)
N/A
N/A
Trial ID
24080086
