Diffuse Large B Cell LymphomaPhase 2NCT06539195
DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9)
A Phase 2 study testing DZD8586 in people with Diffuse Large B Cell Lymphoma, run by Dizal Pharmaceuticals at 14 sites in China.
Trial summary
This study will treat patients with DLBCL whose disease comes back or is not responding to prior therapy. 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- DZD8586
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 14 sitesChina
- Study dates
- 13 Mar 2024to 10 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who meet all the following criteria:
- Male and female ≥ 18 years of age.
- ECOG performance status 0-2.
- Histologically confirmed recurrent or refractory DLBCL.
- Adequate bone marrow reserve and organ system functions.
- Willing to comply with contraceptive restrictions
Who cannot join
- Participants who meet any of the following criteria:
- CNS involvement
- 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.
- Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
- 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.
- Active infection.
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- Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
- Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
- 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.
- Women who are breast feeding.
- History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Research Site
Beijing, Beijing Municipality, 100083
Research Site
Changsha, Hunan, 410031
Research Site
Chengdu, Sichuan, 610041
Research Site
Guangzhou, Guangdong, 510060
Research Site
Hangzhou, Zhejiang, 310009
Research Site
Hefei, Anhui, 230031
Research Site
Jinan, Shandong, 250117
Research Site
Linyi, Shandong, 276002
Research Site
Nanning, Guangxi, 530016
National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, 300020
Research Site
Tianjin, Tianjin Municipality, 300181
Research Site
Wuhan, Hubei, 430023
Research Site
Xi’an, Shanxi, 710061
Research Site
Zhengzhou, Henan, 450003
About this study
Official title: A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
This study will treat patients with DLBCL whose disease comes back or is not responding to prior therapy. 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.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- DZD8586
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DZD8586Drug
Daily dose of DZD8586 at 25 mg
DZD8586Drug
Daily dose of DZD8586 at 50 mg
DZD8586Drug
Daily dose of DZD8586 at 75 mg
| Study group | Role | What they receive |
|---|---|---|
| Daily dose of DZD8586 at 25 mg | Experimental | Not described Receives: Drug: DZD8586 |
| Daily dose of DZD8586 at 50 mg | Experimental | Not described Receives: Drug: DZD8586 |
| Daily dose of DZD8586 at 75 mg | Experimental | Not described Receives: Drug: DZD8586 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate assessed by investigators
Measured: Assessed up to 2 years
Secondary outcomes (1)
Incidence of adverse events
Measured: 30 days after the last dose, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start13 Mar 2024
- Primary completion10 Jun 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lugui Qiu, Principal investigator, National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539195
- Sponsor's protocol ID
- DZ2023B0003
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06539195
- Acronym / sponsor ID
- DZ2023B0003
- Conditions
- Diffuse Large B Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will treat patients with DLBCL whose disease comes back or is not responding to prior therapy. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Daily dose of DZD8586 at 25 mg | Experimental | Drug: DZD8586 |
| Daily dose of DZD8586 at 50 mg | Experimental | Drug: DZD8586 |
| Daily dose of DZD8586 at 75 mg | Experimental | Drug: DZD8586 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female ≥ 18 years of age.
- ECOG performance status 0-2.
- Histologically confirmed recurrent or refractory DLBCL.
- Adequate bone marrow reserve and organ system functions.
- Willing to comply with contraceptive restrictions
Key exclusion criteria (11 listed)
- CNS involvement
- 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.
- Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
- 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.
- Active infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DZD8586Daily dose of DZD8586 at 25 mg | Drug | Daily dose of DZD8586 at 25 mg |
| DZD8586Daily dose of DZD8586 at 50 mg | Drug | Daily dose of DZD8586 at 50 mg |
| DZD8586Daily dose of DZD8586 at 75 mg | Drug | Daily dose of DZD8586 at 75 mg |
Primary outcome
Objective Response Rate assessed by investigators
Time frame: Assessed up to 2 years
1 secondary outcome
Incidence of adverse events
Time frame: 30 days after the last dose, assessed up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lugui Qiu principal investigator
National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DZD8586 in people with Diffuse Large B Cell Lymphoma, run by Dizal Pharmaceuticals at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate assessed by investigators (time frame: Assessed up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.