A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

BeOne Medicines AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

16 Dec 2025 → ongoing

Decision date (initial)

2025-11-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-522860-34-00

ClinicalTrials.gov

NCT06973187

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

To evaluate the efficacy of BGB-16673 compared to pirtobrutinib as measured by progression-free survival (PFS) determined by independent review committee (IRC)

Secondary objectives 4

1. To evaluate the efficacy of BGB-16673 compared to pirtobrutinib, as measured by overall survival (OS)
2. To further evaluate the efficacy of BGB-16673 compared to pirtobrutinib, as measured by additional efficacy endpoints
3. To evaluate the safety of BGB-16673 versus pirtobrutinib
4. To evaluate patient-reported disease and treatment-specific symptoms and functioning in patients receiving BGB-16673 versus pirtobrutinib

Conditions and MedDRA coding

Chronic lymphocytic leukemia (CLL)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, and shared when it is feasible to do so without compromising the privacy of study participants. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data along with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria.
2. Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.
3. Patients with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.

Exclusion criteria 5

1. Known prolymphocytic leukemia or history of, or currently suspected, Richter’s transformation.
2. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL.
3. History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug.
4. Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or non covalent BTKi (ncBTKi). Patients who discontinue cBTKi due solely to toxicity are not eligible
5. History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. PFS, defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for patients with chronic lymphocytic leukemia (CLL) and Lugano classification for patients with small lymphocytic lymphoma (SLL)

Secondary endpoints 8

1. OS, defined as time from the date of randomization to the date of death due to any cause
2. PFS determined by investigator assessment
3. Overall response rate (partial response [PR] or better) determined by IRC and by investigator assessment, per modified 2018 iwCLL criteria for patients with CLL and Lugano classification for patients with SLL
4. Rate of PR with lymphocytosis or higher determined by IRC and by investigator assessment
5. Duration of response determined by IRC and by investigator assessment
6. Time to next anti-CLL/SLL treatment (TTNT)
7. Incidence and severity of treatment-emergent adverse events (TEAEs), serious TEAEs, and laboratory abnormalities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
8. Patient-reported symptoms of global health status (GHS), role functioning, and physical functioning, symptom burden and physical condition/fatigue measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire IL409 (an itemized version of EORTC quality of life questionnaire core 30 [QLQ-C30] and its CLL module CLL17)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

BeOne Medicines AG

Sponsor organisation

BeOne Medicines AG

Address

Aeschengraben 27

City

Basel

Postcode

4051

Country

Switzerland

Scientific contact point

Organisation

BeOne Medicines AG

Contact name

BeOne Medicines Clinical Support

Public contact point

Organisation

BeOne Medicines AG

Contact name

BeOne Medicines Clinical Support

Third parties 19

Locations

10 EU/EEA countries · 60 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 133 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications