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Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaPhase 2NCT07154264

A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)

A Phase 2 study testing DZD8586 and Venetoclax in people with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Dizal Pharmaceuticals at 15 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a phase 2 study to investigate the efficacy and safety of DZD8586 in combination in participants with CLL/SLL. This study consists of two parts: Part A is the safety lead-in phase, and Part B is the dose expansion phase. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DZD8586 and Venetoclax
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
15 sitesChina
Study dates
22 Sep 2025to Jan 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female ≥ 18 years of age.
  • ECOG performance status 0-2, and life expectancy ≥ 6 months.
  • Confirmed newly diagnosis or treatment naïve CLL/SLL with indication for treatment.
  • Patients with SLL must have at least one measurable lesion.
  • Adequate bone marrow reserve and organ functions.
  • Willing to comply with contraceptive restrictions.

Who cannot join

  • Any of previous or current treatment prohibited by protocol.
  • Any unresolved > grade 1 drug-related adverse events.
  • Known or suspected Richter's transformation, or prolymphocytic leukemia.
  • CNS involvement.
  • Active infection.
  • Any of severe cardiac or pulmonary abnormalities.
Show all 10Show fewer
  • Poorly controlled autoimmune anemia or autoimmune thrombocytopenia.
  • Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.
  • Prior malignancy within the past 3 years.
  • Known allergy to study drugs, any of the ingredients of the study drugs, or xanthine oxidase inhibitors or rasburicase.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ling Zhou contact

0086-21-61095755

ling.zhou@dizalpharma.com

15 sites in 1 country

China15 sites, 15 recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Jing

    Recruiting

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

    Bai

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Zhou

    Recruiting

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213003

    Gu

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Niu

    Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

    Li

    Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

    Guo

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Yu

    Recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230031

    Ding

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Li

    Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001

    Shi

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    Yang

    Not yet recruiting

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

    Wuhan, Hubei, 430022

    Fang

    Recruiting

  • Yichang Central People's Hospital

    Yichang, Hubei, 443003

    Cai

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Zhou

    Recruiting

Other trials in China

About this study

Official title: A Phase 2 Study of DZD8586 Combination Therapy in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

This is a phase 2 study to investigate the efficacy and safety of DZD8586 in combination in participants with CLL/SLL.

This study consists of two parts: Part A is the safety lead-in phase, and Part B is the dose expansion phase.

Being tested
DZD8586, Venetoclax
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DZD8586Drug

    Also called Birelentinib

    DZD8586 will be taken orally once daily on days 1-28 of each cycle.

  • VenetoclaxDrug

    Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1.

Study groups in NCT07154264
Study groupRoleWhat they receive
Combination of DZD8586 and VenetoclaxExperimentalDZD8586 will be taken orally once daily on days 1-28 of each cycle. Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1.
Receives: Drug: DZD8586; Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Incidence of Adverse Events

    Measured: 30 days after the last dose

  2. Part B: 2-year progression free survival (PFS) rate assessed by investigator

    Measured: Approximately 5 years

Secondary outcomes (4)

  1. Part A: PFS assessed by investigator

    Measured: Approximately 5 years

  2. Part A: Objective response rate (ORR) assessed by investigator

    Measured: Approximately 5 years

  3. Part B: ORR assessed by investigator

    Measured: Approximately 5 years

  4. Part B: Incidence of Adverse Events

    Measured: 30 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start22 Sep 2025
  3. Primary completionDec 2029 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07154264
Sponsor's protocol ID
DZ2025B0001
Status last verified
Jun 2026
First submitted
18 Aug 2025
Last updated
22 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DZD8586 and Venetoclax in people with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Dizal Pharmaceuticals at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ling Zhou (0086-21-61095755, ling.zhou@dizalpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Incidence of Adverse Events (time frame: 30 days after the last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07154264.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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