A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies

This new study will check how safe and helpful a potential anticancer drug called tacabrutideg is in participants with R/R B-cell malignancies when it is given in combination with other medicines - sonrotoclax in substudy 1, zanubrutinib in substudy 2, mosunetuzumab in substudy 3, and glofitamab in substudy 4. Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Age

18–any

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF
Confirmed diagnosis of a R/R B-cell malignancy
Protocol-defined measurable disease
Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
Adequate organ function
Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax, 30 days after the last dose of tacabrutideg or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment
Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax, 30 days after the last dose of tacabrutideg or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab
Substudies 1, 3, and 4 Inclusion Criterion:
* Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min
* Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression
* Adequate renal function as indicated by eGFR of ≥ 30 mL/min

You may not be if

Treatment-naive B-cell malignancies
Unable to comply with the requirements of the protocol
Active leptomeningeal disease or uncontrolled, untreated brain metastasis
Any malignancy ≤ 2 years before first dose of study treatment except for the specific cancer under investigation in this study or any locally recurring cancer that has been treated curatively
Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening
Prior invasive fungal infection, except if participant agrees to receive secondary antifungal prophylaxis during the entire treatment period
Substudies 1 and 2: Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or who have taken calcineurin inhibitors within 4 weeks prior to consent
Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of tacabrutideg, sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab
Substudy 1 Exclusion Criterion:
* Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor (with exception for participants who relapsed ≥ 24 months after completion of a full course of a prior Bcl-2 inhibitor containing regimen)
Substudy 2 Exclusion Criterion:
* Participants who discontinued prior zanubrutinib treatment due to intolerance
* Prior exposure to a CD20 x CD3 T-cell engager antibody treatment
* All participants with a prior allogeneic stem cell transplant
* Participants with known contraindications to azole antifungal agents, including hypersensitivity reactions

What this study is about