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

NCT07154264 | Recruiting Phase 2

• 1 other identifier: DZ2025B0001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Part A: PFS assessed by investigator

  Approximately 5 years

• Part A: Objective response rate (ORR) assessed by investigator

  Approximately 5 years

• Part B: ORR assessed by investigator

  Approximately 5 years

• Part B: Incidence of Adverse Events

  30 days after the last dose

Study Arms (1)

Combination of DZD8586 and Venetoclax

EXPERIMENTAL

DZD8586 will be taken orally once daily on days 1-28 of each cycle. Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1.

Drug: DZD8586; Drug: Venetoclax

Interventions

DZD8586 DRUG

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

Also known as: Birelentinib

Combination of DZD8586 and Venetoclax

Venetoclax DRUG

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

Combination of DZD8586 and Venetoclax

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female ≥ 18 years of age.
• ECOG performance status 0-2, and life expectancy ≥ 6 months.
• Confirmed newly diagnosis or treatment naïve CLL/SLL with indication for treatment.
• Patients with SLL must have at least one measurable lesion.
• Adequate bone marrow reserve and organ functions.
• Willing to comply with contraceptive restrictions.

You may not qualify if:

• Any of previous or current treatment prohibited by protocol.
• Any unresolved \> grade 1 drug-related adverse events.
• Known or suspected Richter's transformation, or prolymphocytic leukemia.
• CNS involvement.
• Active infection.
• Any of severe cardiac or pulmonary abnormalities.
• Poorly controlled autoimmune anemia or autoimmune thrombocytopenia.
• Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.
• Prior malignancy within the past 3 years.
• Known allergy to study drugs, any of the ingredients of the study drugs, or xanthine oxidase inhibitors or rasburicase.

Sponsors & Collaborators

• Dizal (Jiangsu) Pharmaceutical Co., Ltd.: lead

Study Sites (15)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230031, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

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

Wuhan, Hubei, 430022, China

RECRUITING

Yichang Central People's Hospital

Yichang, Hubei, 443003, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213003, China

RECRUITING

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

NOT YET RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Niu

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Zhou

CONTACT

0086-21-61095755; ling.zhou@dizalpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 4, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)