DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)

May 31, 2026 updated by: Dizal Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • Research Site
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100053
        • Recruiting
        • Research Site
      • Beijing, Beijing Municipality, China, 100191
        • Recruiting
        • Research Site
    • Guandong
      • Guangzhou, Guandong, China, 510280
        • Recruiting
        • Research Site
      • Guangzhou, Guandong, China, 510515
        • Recruiting
        • Research Site
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Research Site
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Research Site
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • Research Site
    • Liaoning
      • Dalian, Liaoning, China
        • Not yet recruiting
        • Research Site
      • Shenyang, Liaoning, China
        • Recruiting
        • Research Site
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Research Site
      • Linyi, Shandong, China
        • Recruiting
        • Research Site
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Research Site
    • Shangxi
      • Taiyuan, Shangxi, China
        • Recruiting
        • Research Site
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Recruiting
        • Research Site
      • Tianjin, Tianjin Municipality, China, 300060
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants who meet all the following criteria:

  1. Male and female ≥ 18 years of age.
  2. ECOG performance status 0-2.
  3. Confirmed diagnosis of CLL/SLL with indication for treatment.
  4. Adequate bone marrow reserve and organ system functions.
  5. Willing to comply with contraceptive restrictions.

Exclusion Criteria:

Participants who meet any of the following criteria:

  1. CNS involvement or Richter transformation.
  2. 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.
  3. Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
  4. 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.
  5. Active infection.
  6. Clinically significant cardiac disorders or abnormalities. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
  7. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
  8. 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.
  9. Women who are breast feeding.
  10. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Daily dose of DZD8586 at 25 mg
Drug: DZD8586
Daily oral dose of DZD8586 at 25 mg.
Other Names:
  • Birelentinib
Drug: DZD8586
Daily oral dose of DZD8586 at 50 mg.
Other Names:
  • Birelentinib
Drug: DZD8586
Daily oral dose of DZD8586 at 75 mg.
Other Names:
  • Birelentinib
Experimental: Daily dose of DZD8586 at 50 mg
Drug: DZD8586
Daily oral dose of DZD8586 at 25 mg.
Other Names:
  • Birelentinib
Drug: DZD8586
Daily oral dose of DZD8586 at 50 mg.
Other Names:
  • Birelentinib
Drug: DZD8586
Daily oral dose of DZD8586 at 75 mg.
Other Names:
  • Birelentinib
Experimental: Daily dose of DZD8586 at 75 mg
Drug: DZD8586
Daily oral dose of DZD8586 at 25 mg.
Other Names:
  • Birelentinib
Drug: DZD8586
Daily oral dose of DZD8586 at 50 mg.
Other Names:
  • Birelentinib
Drug: DZD8586
Daily oral dose of DZD8586 at 75 mg.
Other Names:
  • Birelentinib

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Objective Response Rate assessed by investigators
Time Frame: assessed up to 2 years
assessed up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of adverse event
Time Frame: 30 days after the last dose, assessed up to 2 years
30 days after the last dose, assessed up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dizal Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jianyong Li, First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DZ2023B0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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