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CompletedNCT06539195Updated Aug 4, 2026

DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9)

A Phase 2 interventional study of DZD8586 and DZD8586 in Diffuse Large B Cell Lymphoma, sponsored by Dizal Pharmaceuticals. Completed at 14 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Dizal Pharmaceuticals · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2024, registered Aug 2024).
Phase
Phase 2
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diffuse Large B Cell Lymphoma
03

In context

Lymphoma, Large B-Cell, Diffuse

1,390 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 350 are open to participants now.

This study's enrollment of 59 is above the median of 47 across 1,185 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.

Browse Lymphoma, Large B-Cell, Diffuse studies →

Lead sponsor

Dizal Pharmaceuticals is the lead sponsor of 37 studies on the registry; 15 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 1 (7%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Participants who meet all the following criteria:

  1. Male and female ≥ 18 years of age.
  2. ECOG performance status 0-2.
  3. Histologically confirmed recurrent or refractory DLBCL.
  4. Adequate bone marrow reserve and organ system functions.
  5. Willing to comply with contraceptive restrictions

Exclusion criteria

Exclusion Criteria:

Participants who meet any of the following criteria:

  1. CNS involvement
  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. 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    Daily dose of DZD8586 at 25 mg

    Drug: DZD8586

  • Experimental
    Daily dose of DZD8586 at 50 mg

    Drug: DZD8586

  • Experimental
    Daily dose of DZD8586 at 75 mg

    Drug: DZD8586

Interventions

  • DrugDZD8586

    Daily dose of DZD8586 at 25 mg

  • DrugDZD8586

    Daily dose of DZD8586 at 50 mg

  • DrugDZD8586

    Daily dose of DZD8586 at 75 mg

06

What researchers measure

Primary outcomes

  1. Objective Response Rate assessed by investigators

    Time frame: Assessed up to 2 years

Secondary outcomes

  1. Incidence of adverse events

    Time frame: 30 days after the last dose, assessed up to 2 years

07

Study locations

14 sites
  • Research Site
    Hefei, Anhui 230031, China
  • Research Site
    Beijing, Beijing Municipality 100083, China
  • Research Site
    Guangzhou, Guangdong 510060, China
  • Research Site
    Nanning, Guangxi 530016, China
  • Research Site
    Zhengzhou, Henan 450003, China
  • Research Site
    Wuhan, Hubei 430023, China
  • Research Site
    Changsha, Hunan 410031, China
  • Research Site
    Jinan, Shandong 250117, China
  • Research Site
    Linyi, Shandong 276002, China
  • Research Site
    Xi’an, Shanxi 710061, China
  • Research Site
    Chengdu, Sichuan 610041, China
  • 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, China
  • Research Site
    Tianjin, Tianjin Municipality 300181, China
  • Research Site
    Hangzhou, Zhejiang 310009, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06539195
Lead sponsor
Dizal Pharmaceuticals
Responsible party
Sponsor
First posted
Aug 6, 2024
Start date
Mar 13, 2024
Primary completion
Jun 10, 2026
Completion
Jun 10, 2026
Last update
Aug 4, 2026

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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