NCT06539182 DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)
| NCT ID | NCT06539182 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Dizal Pharmaceuticals |
| Condition | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 155 participants |
| Start Date | 2024-04-29 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 155 participants in total. It began in 2024-04-29 with a primary completion date of 2027-09.
⚠ 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 study will treat patients with CLL/SLL whose disease comes back or is not responding to prior therapy, or if they can not bear side effects of the prior treatment. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.
Eligibility Criteria
Inclusion Criteria: Participants who meet all the following criteria: 1. Male and female ≥ 18 years of age. 2. ECOG performance status 0-2. 3. Confirmed diagnosis of CLL/SLL with indication for treatment. 4. Adequate bone marrow reserve and organ system functions. 5. Willing to comply with contraceptive restrictions. Exclusion Criteria: Participants who meet any of the following criteria: 1. CNS involvement or Richter transformation. 2. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, monoclonal antibodies and antibody-drug conjugates within 28 days. 3. Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks. 4. Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A inhibitors or inducers. 5. Active infection. 6. Clinically significant cardiac disorders or abnormalities. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months. 7. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption. 8. Another malignancy within 2 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer. 9. Women who are breast feeding. 10. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.
Contact & Investigator
Jianyong Li
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Frequently Asked Questions
Who can join the NCT06539182 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 NCT06539182 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 NCT06539182 currently recruiting?
Yes, NCT06539182 is actively recruiting participants. Contact the research team at Tianmo.Sun@dizalpharma.com for enrollment information.
Where is the NCT06539182 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Beijing, China, Guangzhou, China and 11 additional locations.
Who is sponsoring the NCT06539182 clinical trial?
NCT06539182 is sponsored by Dizal Pharmaceuticals. The principal investigator is Jianyong Li at First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital. The trial plans to enroll 155 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.