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New hope for blood cancer patients: experimental drug BGB-16673 enters phase 3 trial

NCT ID NCT06970743

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 7 times

Summary

This Phase 3 trial is testing an experimental oral drug called BGB-16673 against standard treatments (bendamustine plus rituximab or high-dose methylprednisolone plus rituximab) in 150 people with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have already been treated with a BTK inhibitor. The main goal is to see if BGB-16673 can delay cancer progression or improve survival. Participants are randomly assigned to receive either the new drug or one of the standard therapies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BGB-16673 (an experimental oral drug)
What this could lead to
If successful, this could offer a new treatment option for people with CLL or SLL whose cancer has returned or stopped responding to current BTK inhibitor therapy.
What could go wrong
This is an early-stage Phase 3 trial with only 150 participants, so results may not apply to everyone. The experimental drug may not work better than standard treatments and could have unknown side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

153 people

The number who actually took part.

Started

May 2025

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Confirmed diagnosis of CLL/SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria. 2. Previously received treatment for CLL/SLL with a covalent BTKi. 3. Measurable disease by computer tomography/magnetic resonance imaging for patients with SLL. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 5. Adequate bone marrow function 6. Adequate kidney and liver function 7. Adequate blood clotting function Exclusion Criteria: 1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation 2. 2\. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or chimeric antigen receptor-T cell (unless ≥ 6 months after cell infusion) 3. History of severe allergic reactions or hypersensitivity to the active ingredient and excipients of study treatment (BGB-16673, bendamustine, rituximab, chlorambucil, or obinutuzumab) 4. Current or history of central nervous system involvement 5. History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug 6. History of confirmed progressive multifocal leukoencephalopathy. 7. Active fungal, bacterial, and/or viral infection requiring parenteral systemic therapy 8. Clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lymphocytic leukemia Small lymphocytic lymphoma

Contacts and locations

Locations

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272000, China

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 201203, China

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning, 116001, China

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256603, China

  • Chang Bing Show Chwan Memorial Hospital

    Changhua, 505029, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chongqing University Three Gorges Central Hospital

    Chongqing, Chongqing Municipality, 404000, China

  • Deyangs People Hospital

    Deyang, Sichuan, 618000, China

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • Guizhou Provincial Peoples Hospital

    Guiyang, Guizhou, 550002, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Henan Provincial Peoples Hospital

    Zhengzhou, Henan, 450003, China

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch

    Tianjin, Tianjin Municipality, 301617, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Linyi Cancer Hospital

    Linyi, Shandong, 276001, China

  • Lishui Central Hospital

    Lishui, Zhejiang, 323000, China

  • Meizhou People Hospital

    Meizhou, Guangdong, 514031, China

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008, China

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 100044, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000, China

  • Peoples Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830001, China

  • Qinghai University Affiliated Hospital

    Xining, Qinghai, 810001, China

  • Red Cross Hospital of Yulin City

    Yulin, Guangxi, 537000, China

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032, China

  • Shenzhen Nanshan Peoples Hospital

    Shenzhen, Guangdong, 518052, China

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, 610071, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch

    Hangzhou, Zhejiang, 310018, China

  • Sun Yat Sen University Cancer Center Huangpu Branch

    Guangzhou, Guangdong, 510555, China

  • Taian City Central Hospital

    Taian, Shandong, 271099, China

  • Taihe Hospital

    Shiyan, Hubei, 442000, China

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230000, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 630014, China

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021, China

  • The First Affiliated Hospital of Harbin Medical Universitynangang Branch

    Harbin, Heilongjiang, 150001, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

    Hangzhou, Zhejiang, 310002, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The First Peoples Hospital of Changde City

    Changde, Hunan, 415000, China

  • The First Peoples Hospital of Yunnan Province

    Kunming, Yunnan, 650034, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The Second Peoples Hospital of Yibin

    Yibin, Sichuan, 644000, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011, China

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • Xuchang Central Hospitalluminghu Branch

    Xuchang, Henan, 461000, China

  • Yichang Central Peoples Hospital

    Yichang, Hubei, 443003, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000, China

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