Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies

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What is this study about?

This clinical trial is studying treatments for B-cell malignancies that have returned or not responded to previous treatments. The study will test different combinations of medications, including BGB-16673, zanubrutinib, sonrotoclax, mosunetuzumab, obinutuzumab, and glofitamab. The purpose is to find safe and effective treatment combinations for patients whose cancer has come back or did not respond to earlier treatments.

The medications will be given in different ways – some as tablets taken by mouth and others through an intravenous infusion (given directly into a vein) or subcutaneous injection (given under the skin). The study will be conducted in two parts. The first part will determine the right dose of the drug combinations, while the second part will further study how well these doses work and what side effects they may cause.

Throughout the study, doctors will monitor patients’ health, check how well the treatment is working, and track any side effects. They will look at how many patients respond to treatment and how long the response lasts. For some patients, they will also measure the amount of cancer cells remaining in the blood or bone marrow after treatment.

1 Initial Treatment Phase

You will receive a combination of medications to treat relapsed or refractory B-cell malignancies (a type of blood cell disorder that has returned or did not respond to previous treatment)

The main medication, BGB-16673, will be given as tablets that you take by mouth

Depending on your assigned treatment group, you may also receive other medications through different methods:

– Gazyvaro (obinutuzumab) through intravenous infusion (through a vein)

– Zanubrutinib as oral capsules

– Columvi (glofitamab) through intravenous infusion

– Mosunetuzumab as an injection under the skin

2 Monitoring Period

Your health status will be regularly checked through various tests and examinations

Doctors will monitor for any side effects or reactions to the medications

The effectiveness of the treatment will be assessed through blood tests and other medical examinations

Your response to treatment will be measured, including how long it takes for the treatment to work and how long the response lasts

3 Safety Assessments

Regular checks will be performed to monitor:

– Any side effects that may occur during treatment

– How well your organs are functioning

– Your overall health status

Blood samples will be taken to check the levels of medications in your body

4 Follow-up Period

After completing the treatment, you will need to continue using birth control methods for a specified period:

– 30 days after the last dose of BGB-16673 or zanubrutinib

– 90 days after the last dose of sonrotoclax

– 3 months after the last dose of mosunetuzumab

– 18 months after obinutuzumab treatment

– 2 months after the last dose of glofitamab

Who Can Join the Study?

Must be able to understand and sign the informed consent form and follow all requirements listed in it
Must have a confirmed diagnosis of relapsed or refractory B-cell malignancy (cancer that has returned or did not respond to previous treatment)
Must have disease that can be measured according to the study protocol
Must have good physical function with an ECOG Performance Status of 0-1 (able to perform daily activities with minimal limitations)
Must have adequate organ function
Must have adequate kidney function with:
- For Sub-study 2: eGFR (kidney filtration rate) of ≥30 mL/min
- For Sub-studies 1, 3 and 4: eGFR of ≥50 mL/min
For Sub-study 2: Must be either new to BTK inhibitor treatment or have stopped previous BTK inhibitor treatment for reasons other than disease progression
For women who can become pregnant:
- Must use effective birth control during the study
- Must not donate eggs during the study and for specified time after last treatment
- Must have negative pregnancy test 10-14 days before starting treatment
For men who are not sterile:
- Must use effective birth control during the study
- Must not donate sperm during the study and for specified time after last treatment

Who Cannot Join the Study?

Age below 18 years old
Known active central nervous system (CNS) involvement from B-cell malignancy
Previous treatment with similar therapy (BGB-16673) or participation in another clinical trial within 30 days
Presence of active, uncontrolled infections
Significant heart problems, including heart failure or unstable heart rhythm
Severe kidney or liver problems
Pregnant or breastfeeding women
History of other cancers within the past 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
Known HIV infection (human immunodeficiency virus)
Active hepatitis B or C infection
Major surgery within 4 weeks before starting the study
Mental conditions that could interfere with study participation
Known allergic reactions to similar medications
Uncontrolled high blood pressure
Any other serious medical condition that could make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
IRCCS Humanitas Research Hospital	Rozzano	Italy
University Hospital Jena KöR	Jena	Germany

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Sbxxdqt Wxmknxdzhb W Ofqkx Sok z otzv	Opole	Poland
Nafckplj Ivpmggqb Okrlavvzf Ivp Mtwnk Szbgjghsbabtitwihhkpfvghlpxv Imwoggro Bivmthoo	Cracow	Poland
Avjkapa Uocle Svbyjetsc Lcrlqw Dg Bmokgxo	Bologna	Italy
Uqcsdfdpfeyoec Cloqogr Kfvzmemnw	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	11.09.2025
Italy	Recruiting	11.09.2025
Poland	Recruiting	11.09.2025

Trial locations

Investigated drugs:

BGB-16673 is an experimental medication known as a BTK-degrader. It works by breaking down a specific protein (BTK) that is important in B-cell cancers. This medication is being studied in combination with other treatments for patients who have B-cell blood cancers that have either come back or didn’t respond well to previous treatments.

The trial description mentions that other agents will be combined with BGB-16673, but specific names of these additional medications are not provided in the source data.

B-Cell Malignancies – A group of blood cancers that develop from abnormal B lymphocytes, which are white blood cells that normally help fight infections. These disorders begin in the bone marrow, where B-cells are produced. As abnormal B-cells accumulate, they can spread to various parts of the body, including lymph nodes, blood, and other tissues. The condition can progress from an initial stage where there are too many abnormal B-cells to more advanced stages affecting multiple body systems. The disease can occur in various forms, including different types of lymphomas and leukemias. B-cell malignancies can be either slow-growing (indolent) or fast-growing (aggressive).

Trial ID:

2024-516234-35-00

Protocol code:

BGB-16673-104

NCT ID:

NCT06634589

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies

What is this study about?

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Who Cannot Join the Study?