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

NCT07154264 · tracked via the Priya Life Science China tracker

Sponsor

Dizal Pharmaceuticals

Phase

Phase 2

Started

2025-09-22

Last updated

2026-06-22

Condition(s) studied

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Investigational drug(s) / intervention(s)

DZD8586Venetoclax

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

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

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 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 or other 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 xanthine oxidase inhibitors or rasburicase.

Primary outcome measure(s)

Part A: Incidence of Adverse Events — 30 days after the last dose
Part B: 2-year progression free survival (PFS) rate assessed by investigator — Approximately 5 years

Trial sites (15)

Facility	City	Region	Status
Anhui Provincial Cancer Hospital	Hefei	Anhui	Recruiting
Peking University Third Hospital	Beijing	Beijing Municipality	Recruiting
Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong	Recruiting
Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	Recruiting
Henan Cancer Hospital	Zhengzhou	Henan	Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	Recruiting
Yichang Central People's Hospital	Yichang	Hubei	Recruiting
Hunan Cancer Hospital	Changsha	Hunan	Recruiting
The First People's Hospital of Changzhou	Changzhou	Jiangsu	Recruiting
Affiliated Hospital of Nantong University	Nantong	Jiangsu	Recruiting
The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	Recruiting
The First Bethune Hospital of Jilin University	Changchun	Jilin	Recruiting
Shengjing Hospital of China Medical University	Shenyang	Liaoning	Not Yet Recruiting
West China Hospital of Sichuan University	Chengdu	Sichuan	Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	Recruiting

On this site

📄 Venclexta (venetoclax) drug profile →

More Dizal Pharmaceuticals trials in China

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A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6) Recruiting

Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN2) Recruiting

A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19) Recruiting

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Other trials for the same condition

A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6) Recruiting

Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader Recruiting

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07154264 on ClinicalTrials.gov ↗ ← All trials in China