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

Last updated: December 22, 2025
Sponsor: Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Chronic Lymphocytic Leukemia

Lymphocytic Leukemia, Chronic

Treatment

Venetoclax

DZD8586

Clinical Study ID

NCT07154264
DZ2025B0001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female ≥ 18 years of age.

  2. ECOG performance status 0-2, and life expectancy ≥ 6 months.

  3. Confirmed newly diagnosis or treatment naïve CLL/SLL with indication for treatment.

  4. Patients with SLL must have at least one measurable lesion.

  5. Adequate bone marrow reserve and organ functions.

  6. Willing to comply with contraceptive restrictions.

Exclusion

Exclusion Criteria:

  1. Any of previous or current treatment prohibited by protocol.

  2. Any unresolved > grade 1 drug-related adverse events.

  3. Known or suspected Richter's transformation, or prolymphocytic leukemia.

  4. CNS involvement.

  5. Active infection.

  6. Any of severe cardiac or pulmonary abnormalities.

  7. Poorly controlled autoimmune anemia or autoimmune thrombocytopenia.

  8. Poorly controlled gastrointestinal disorder, inadequate absorption of medication orother systemic diseases.

  9. Prior malignancy within the past 3 years.

  10. Known allergy to study drugs, any of the ingredients of the study drugs, or xanthineoxidase inhibitors or rasburicase.

Study Design

Total Participants: 66
Treatment Group(s): 2
Primary Treatment: Venetoclax
Phase: 2
Study Start date:
September 22, 2025
Estimated Completion Date:
January 31, 2030

Connect with a study center

  • Anhui Provincial Cancer Hospital

    Hefei 1808722, Anhui 1818058 230031
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing 1816670, Beijing Municipality 2038349 100191
    China

    Active - Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou 1809858, Guangdong 1809935 510515
    China

    Active - Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou 1809858, Guangdong 1809935 510280
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou 1784658, Henan 1808520 450008
    China

    Active - Recruiting

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

    Wuhan 1791247, Hubei 1806949 430022
    China

    Active - Recruiting

  • Yichang Central People's Hospital

    Yichang 1786764, Hubei 1806949 443003
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha 1815577, Hunan 1806691 410013
    China

    Active - Recruiting

  • The First People's Hospital of Changzhou

    Changzhou 1815456, Jiangsu 1806260 213003
    China

    Active - Recruiting

  • Affiliated Hospital of Nantong University

    Nantong 1799722, Jiangsu 1806260 226001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang 1800163, Jiangxi 1806222 330006
    China

    Active - Recruiting

  • The First Bethune Hospital of Jilin University

    Changchun 2038180, Jilin 2036500 130021
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang 2034937, Liaoning 2036115 110004
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu 1815286, Sichuan 1794299 610041
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764 310003
    China

    Active - Recruiting

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