A Phase 1/2 interventional study of Tacabrutideg in B-cell Malignancy, Non-Hodgkin Lymphoma and Mantle Cell Lymphoma, sponsored by BeOne Medicines. Recruiting at 29 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by BeOne Medicines · Phase 1/2, Interventional, and Treatment
Among 195 studies in Lymphoma, Non-Hodgkin with a site in China — 82 open to participants now, 109 under way, 14 of them phase 3. Lymphoma, Non-Hodgkin · China.
Among the 195 studies in Lymphoma, Non-Hodgkin with a site in China, this one is the 43rd largest by planned enrollment of the 183 interventional ones that give a count, is one of 28 that started in 2022, is one of 42 in phase 1/2, reaches primary completion later than 71 of the 108 other live ones, and was the 109th registered.
2,287 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 287 are open to participants now.
Browse Lymphoma, Non-Hodgkin studies →82 of the 195 studies in Lymphoma, Non-Hodgkin with a site in China are open now. Recruiting first, the newest first:
Chinese PLA General Hospital · Sites in China
Ages 18–75
Chengdu Anticancer Bioscience, Ltd. · Sites in China
Ages 18–75
Chinese PLA General Hospital · Sites in China
Ages 18–75
Ruijin Hospital · Sites in China
Ages 18–75
Jecho Biopharmaceuticals Co., Ltd. · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 246 Lymphoma, Non-Hodgkin studies recruiting now, 146 (59%) set no upper age limit and 77 (31%) stop at 75 or younger; 68 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
195 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 121 · Phase 2 67 · Phase 3 26 · Phase 4 3
First in 1997; this study’s year is marked. 28 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 146 is above the median of 40 across 1,883 interventional studies indexed under Lymphoma, Non-Hodgkin.
Median enrollment 58 across the 183 interventional studies, 750 across the 12 observational. Of the 45 that completed or were terminated, 12 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
122 of 195 have an industry lead sponsor. The 10 most frequent:
BeOne Medicines is the lead sponsor of 69 studies on the registry; 49 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
BeOne Medicines has 4 studies filed under Lymphoma, Non-Hodgkin — fewer than ten, so there is no comparison to draw.
26 of the studies in Lymphoma, Non-Hodgkin with a site in China that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02972840Phase 3Acerta Pharma BVA Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL | 2027-02-15 |
| NCT04529772Phase 3Acerta Pharma BVA Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) | 2027-02-22 |
| NCT05578976Phase 3GenmabA Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) | 2027-06 |
| NCT05254743Phase 3Loxo Oncology, Inc.A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) | 2027-10 |
| NCT04662255Phase 3Loxo Oncology, Inc.Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) | 2027-11 |
Add all 26 to your calendar (.ics) → With an account.
Among the 195 studies in Lymphoma, Non-Hodgkin with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts
A B-cell malignancy is a type of cancer that starts in white blood cells called B-cells. These cancers can affect the lymph nodes, bone marrow, blood, and spleen. Examples include marginal zone lymphoma, follicular lymphoma, non-Hodgkin lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, and diffuse large B cell lymphoma.
Tacabrutideg is a type of medicine called a BTK degrader. BTK (Bruton's tyrosine kinase) is a protein that helps cancer cells survive. Tacabrutideg is designed to attach to the BTK protein and tag it for removal, so that the body's own cellular "clean-up" system breaks it down and clears it away. When more BTK is removed from the body, it interferes with the signals needed for the cancer cells to multiply and survive and may also reduce the chance of the cancer becoming resistant to treatment.
The purpose of this study is to test whether tacabrutideg is safe and if it can help treat B-cell malignancies. The main goals are to ensure the drug is safe by monitoring side effects and to understand how well patients respond to the treatment and whether their cancers shrink or disappear.
This study consists of two parts: dose escalation and dose expansion. During the dose escalation part, the study doctors will test different doses of the study drug to find the recommended dose that people can take without having serious side effects. During the dose expansion part, the study doctors will test the study drug in a larger number of people using the dose or doses identified from dose escalation. The study is open label, which means that the participants and the study doctors will know what treatment is received.
This study will enroll approximately 146 participants with B-cell malignancies at multiple centers worldwide.
The approximate duration of participation for each participant is up to 3 years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.
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.
The criteria were revised on the registry on Oct 21, 2026. See what changed
Key Inclusion Criteria
Key Exclusion Criteria
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tacabrutideg will be orally administered.
Drug: Tacabrutideg
Tacabrutideg will be orally administered.
Drug: Tacabrutideg
Tacabrutideg will be administered at the recommended Phase 2 dose (RP2D) that was identified in Part 1.
Drug: Tacabrutideg
Orally administered
Also known as: BGB-16673
Phase 1: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE 5.0), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria.
Time frame: From first dose of the study drug(s) to 30 days after the last dose or before initiation of a new anticancer therapy, whichever occurs first (up to approximately 3 years)
Phase 1: Recommended Phase 2 dose (RP2D) of Tacabrutideg
As determined by the sponsor based on the Safety Monitoring Committee's recommendation considering totality of the available clinical safety, clinical efficacy, pharmacokinetics, and pharmacodynamics data.
Time frame: From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks)
Phase 1a: Maximum tolerated dose (MTD) of Tacabrutideg
The highest dose evaluated as recommended by the Bayesian Optimal Interval Design with Informative Prior (iBOIN) design or the maximum assessed dose (MAD).
Time frame: From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks)
Phase 2: Overall Response Rate (ORR) in participants with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL)
ORR is defined as the percentage of participants with partial response or better according to the Investigators assessment and as determined by Lugano criteria.
Time frame: Up to approximately 3 years
Phase 2: ORR in participants with R/R Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
ORR is defined as the percentage of participants with partial response or better as assessed by the Independent Review Committee (IRC) and determined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL and by Lugano criteria for SLL
Time frame: Up to approximately 3 years
Maximum observed plasma concentration (Cmax) After a Single Dose of Tacabrutideg
Time frame: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
Time to reach maximum observed plasma concentration (Tmax) After a Single Dose of Tacabrutideg
Time frame: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
Minimum observed plasma concentration (Cmin) After a Single Dose of Tacabrutideg
Time frame: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
Apparent terminal elimination half-life (t1/2) After a Single Dose of Tacabrutideg
Time frame: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
Area under the plasma-concentration curve (AUC) After a Single Dose of Tacabrutideg
Time frame: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
Apparent oral clearance (CL/F) After a Single Dose of Tacabrutideg
Time frame: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
Apparent volume of distribution (Vz/F) After a Single Dose of Tacabrutideg
Time frame: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
Maximum observed steady state plasma concentration (Css,max) of Tacabrutideg
Time frame: Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose
Time to reach maximum observed steady state plasma concentration (Tss,max) of Tacabrutideg
Time frame: Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose
Minimum observed steady state plasma concentration (Css,min) of Tacabrutideg
Time frame: Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose
Steady state area under the plasma concentration-time curve (AUC) of Tacabrutideg
Time frame: Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose
Accumulation ratios of Cmax and AUC of Tacabrutideg
Time frame: Phase 1a: Day 1 pre-dose up to 72 hours post-dose, Week 5 pre-dose up to 8 hours post-dose; Phase 1b: Week 1 and Week 5 pre-dose up to 6 hours post-dose; Phase 2: Week 1 and Week 5 pre-dose up to 8 hours post-dose
Bruton's tyrosine kinase (BTK) protein degradation in peripheral blood after Tacabrutideg monotherapy
Time frame: Phase 1a: Day 1 pre-dose up to 72 hours post-dose, Week 5 pre-dose and 8 hours post-dose, Week 9 pre-dose; Phase 1b: Week 1 and Week 5 pre-dose and 6 hours post-dose, Week 9 pre-dose; Phase 2: Week 1, Week 5, Week 9 pre-dose
Phase 1: ORR
ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using International Workshop on Chronic Lymphocytic Leukemia (iwCLL), Owen, and Lugano criteria.
Time frame: Up to approximately 3 years
Phase 1: Major Response Rate (MRR) in participants with Waldenstrom macroglobulinemia (WM)
MRR is defined as the percentage of participants who achieved complete response (CR), very good partial response (VGPR), and partial response (PR), as assessed by investigators for participants with WM only.
Time frame: Up to approximately 3 years
Phase 2: Number of participants with AEs and SAEs
Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE 5.0).
Time frame: From first dose of the study drug(s) to 30 days after the last dose or before initiation of a new anticancer therapy, whichever occurs first (up to approximately 3 years)
Phase 2: Duration of Response (DOR) Participants with R/R CLL/SLL
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as determined by IRC and investigators.
Time frame: Up to approximately 3 years
Phase 2: DOR in Participants with R/R MCL
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as determined by investigators.
Time frame: Up to approximately 3 years
Phase 2: Time to Response (TTR) in Participants with R/R CLL/SLL
TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better) as determined by IRC and investigators.
Time frame: Up to approximately 3 years
Phase 2: TTR in Participants with R/R MCL
TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better) as determined by investigators.
Time frame: Up to approximately 3 years
Phase 2: Progression Free Survival (PFS) in Participants with R/R CLL/SLL
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as determined by IRC and investigators.
Time frame: Up to approximately 3 years
Phase 2: PFS in Participants with R/R MCL
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as determined by investigators.
Time frame: Up to approximately 3 years
Phase 2: Overall Survival (OS)
OS is defined as the time from first study drug administration to the date of death due to any cause.
Time frame: Up to approximately 3 years
Phase 2: Best Overall Response (BOR) of Partial Response with Lymphocytosis (PR-L) in Participants with R/R CLL/SLL
BOR of PR-L or better as determined by IRC and by investigators per iwCLL criteria for CLL and per Lugano criteria for SLL
Time frame: Up to approximately 3 years
Phase 2: DOR of Partial Response with Lymphocytosis (PR-L) in Participants with R/R CLL/SLL
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as determined by IRC and by investigators.
Time frame: Up to approximately 3 years
Phase 2: TTR of Partial Response with Lymphocytosis (PR-L) in Participants with R/R CLL/SLL
TTR is defined as the time from study treatment start to date of the earliest qualifying response as determined by IRC and investigators.
Time frame: Up to approximately 3 years
Phase 2: Change from baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (NFLymSI-18) Disease-related Symptom Physical and Treatment Side Effect Subscales in participants with R/R MCL
The NFLymSI-18 questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score. A mixed model for repeated measures (MMRM) will be used to estimate the mean change from baseline for NFlymSI-18 subscales of Disease-Related Symptoms Physical (DRSP), and "treatment side effects" (TSE).
Time frame: Baseline; Day 1 of Weeks 5, 13, 25, and 37; 30 days after the last dose (up to approximately 3 years)
Phase 2: Mean change from baseline for the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu ) questionnaire Physical Well-being and Functional Well-being Subscales for participants with R/R CLL/SLL
FACT-Leu is a 44-item patient reported outcome questionnaire with five subscales used to measure health-related quality of life (HRQoL) in leukemia patients. Each question is scored from 0 (not at all) to 4 (very much).
Time frame: Baseline; Day 1 of Weeks 5, 13, 25, and 37; 30 days after the last dose (up to approximately 3 years)
Plan to share: Yes — 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, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See plan description
Access criteria: See plan description
Data sharing details ↗ · beonemedicines.com
No publications or documents are linked to this record.
Started May 2022 (actual). Primary completion is estimated for Jun 2027, 61 months after the start.
Of 69 industry-sponsored phase 1/2 interventional studies under Lymphoma, Non-Hodgkin, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 103. This study's planned 61 months is close to that.
Counting every sponsor, half of 135 studies reached it within 72 months; a quarter within 50 and three quarters within 104.
Primary completion moved once since we started tracking on Sep 25, 2026: Jan 2029 → Jun 2027, on Oct 21, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Tacabrutideg