NCT07154264 A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)
| NCT ID | NCT07154264 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Dizal Pharmaceuticals |
| Condition | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2025-09-22 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 66 participants in total. It began in 2025-09-22 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Niu
PRINCIPAL INVESTIGATOR
West China Hospital
Frequently Asked Questions
Who can join the NCT07154264 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07154264 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07154264 currently recruiting?
Yes, NCT07154264 is actively recruiting participants. Contact the research team at ling.zhou@dizalpharma.com for enrollment information.
Where is the NCT07154264 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Guangzhou, China, Guangzhou, China and 11 additional locations.
Who is sponsoring the NCT07154264 clinical trial?
NCT07154264 is sponsored by Dizal Pharmaceuticals. The principal investigator is Niu at West China Hospital. The trial plans to enroll 66 participants.
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