Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaPhase 2NCT06539182
DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)
A Phase 2 study testing DZD8586 in people with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Dizal Pharmaceuticals at 17 sites in China.
Trial summary
This study will treat patients with CLL/SLL whose disease comes back or is not responding to prior therapy, or if they can not bear side effects of the prior treatment. This study will assess the anti-tumor activity of DZD8586 as monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- What is being tested?
- DZD8586
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 17 sitesChina
- Study dates
- 29 Apr 2024to Mar 2028
- 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
- Participants who meet all the following criteria:
- Male and female ≥ 18 years of age.
- ECOG performance status 0-2.
- Confirmed diagnosis of CLL/SLL with indication for treatment.
- Adequate bone marrow reserve and organ system functions.
- Willing to comply with contraceptive restrictions.
Who cannot join
- Participants who meet any of the following criteria:
- CNS involvement or Richter transformation.
- Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, monoclonal antibodies and antibody-drug conjugates within 28 days.
- Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
- Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A inhibitors or inducers.
- Active infection.
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- Clinically significant cardiac disorders or abnormalities. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
- Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
- Another malignancy within 2 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.
- Women who are breast feeding.
- History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
China17 sites, 17 recruiting
- Recruiting
Research Site
Beijing, Beijing Municipality, 100053
- Recruiting
Research Site
Beijing, Beijing Municipality, 100191
- Recruiting
Research Site
Changchun, Jilin
- Not yet recruiting
Research Site
Dalian, Liaoning
- Recruiting
Research Site
Guangzhou, Guandong, 510280
- Recruiting
Research Site
Guangzhou, Guandong, 510515
- Recruiting
Research Site
Hefei, Anhui
- Recruiting
Research Site
Jinan, Shandong
- Recruiting
Research Site
Linyi, Shandong
- Recruiting
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu
- Recruiting
Research Site
Shanghai, Shanghai Municipality
- Recruiting
Research Site
Shenyang, Liaoning
- Recruiting
Research Site
Taiyuan, Shangxi
- Recruiting
Research Site
Tianjin, Tianjin Municipality, 300020
- Recruiting
Research Site
Tianjin, Tianjin Municipality, 300060
- Recruiting
Research Site
Wuhan, Hubei
- Recruiting
Research Site
Zhengzhou, Henan
About this study
Official title: A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
This study will treat patients with CLL/SLL whose disease comes back or is not responding to prior therapy, or if they can not bear side effects of the prior treatment. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.
- Being tested
- DZD8586
- 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
Daily oral dose of DZD8586 at 25 mg.
DZD8586Drug
Also called Birelentinib
Daily oral dose of DZD8586 at 50 mg.
DZD8586Drug
Also called Birelentinib
Daily oral dose of DZD8586 at 75 mg.
| Study group | Role | What they receive |
|---|---|---|
| Daily dose of DZD8586 at 25 mg | Experimental | Not described Receives: Drug: DZD8586 |
| Daily dose of DZD8586 at 50 mg | Experimental | Not described Receives: Drug: DZD8586 |
| Daily dose of DZD8586 at 75 mg | Experimental | Not described Receives: Drug: DZD8586 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate assessed by investigators
Measured: assessed up to 2 years
Secondary outcomes (1)
Incidence of adverse event
Measured: 30 days after the last dose, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start29 Apr 2024
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaStudies of the same condition, open and under way.
- More trials run by Dizal PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianyong Li, Principal investigator, First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539182
- Sponsor's protocol ID
- DZ2023B0002
- Status last verified
- May 2026
- First submitted
- 1 Aug 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- ClinicalTrials.gov ID
- NCT06539182
- Acronym / sponsor ID
- DZ2023B0002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will treat patients with CLL/SLL whose disease comes back or is not responding to prior therapy, or if they can not bear side effects of the prior treatment. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Daily dose of DZD8586 at 25 mg | Experimental | Drug: DZD8586 |
| Daily dose of DZD8586 at 50 mg | Experimental | Drug: DZD8586 |
| Daily dose of DZD8586 at 75 mg | Experimental | Drug: DZD8586 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female ≥ 18 years of age.
- ECOG performance status 0-2.
- Confirmed diagnosis of CLL/SLL with indication for treatment.
- Adequate bone marrow reserve and organ system functions.
- Willing to comply with contraceptive restrictions.
Key exclusion criteria (11 listed)
- CNS involvement or Richter transformation.
- Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, monoclonal antibodies and antibody-drug conjugates within 28 days.
- Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
- Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A inhibitors or inducers.
- Active infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DZD8586Also: BirelentinibDaily oral dose of DZD8586 at 25 mg. | Drug | Daily dose of DZD8586 at 25 mg |
| DZD8586Also: BirelentinibDaily oral dose of DZD8586 at 50 mg. | Drug | Daily dose of DZD8586 at 50 mg |
| DZD8586Also: BirelentinibDaily oral dose of DZD8586 at 75 mg. | Drug | Daily dose of DZD8586 at 75 mg |
Primary outcome
Objective Response Rate assessed by investigators
Time frame: assessed up to 2 years
1 secondary outcome
Incidence of adverse event
Time frame: 30 days after the last dose, assessed up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianyong Li principal investigator
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DZD8586 in people with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Dizal Pharmaceuticals at 17 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 11 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 2 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 17 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 Tianmo Sun (0086-21-61097800, Tianmo.Sun@dizalpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate assessed by investigators (time frame: assessed up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.