RecruitingPhase 2NCT07154264

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

A Phase 2 Study of DZD8586 Combination Therapy in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Sponsor

Dizal (Jiangsu) Pharmaceutical Co., Ltd.

Enrollment

66 participants

Start Date

Sep 22, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing DZD8586 in combination with other drugs in people who have never been treated for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) — two closely related slow-growing blood cancers. **You may be eligible if...** - You are 18 or older - You have newly diagnosed CLL or SLL that requires treatment - Your overall health is reasonably good (ECOG score 0–2) - You have adequate bone marrow and organ function - You are willing to follow contraception guidelines **You may NOT be eligible if...** - You have had prior treatment for CLL/SLL - You have a suspected transformation to a more aggressive cancer (Richter's transformation) - You have cancer involvement in the brain - You have an active infection or serious heart or lung condition - You have a prior cancer diagnosis within the past 3 years - You have an allergy to the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDZD8586

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

DRUGVenetoclax

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

Locations(15)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

Yichang Central People's Hospital

Yichang, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07154264

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