ClinTrial Refer

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

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

Auckland City Hospital (Haematology)

2 Park Rd, Grafton, Auckland 1023, New Zealand

Pending

Primary Contact : Charlie Stratton, clinicaltrialrefer@tewhatuora.govt.nz , N/A

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

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

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