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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

155

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Dizal Pharmaceuticals

Investigators

  • 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)

April 29, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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