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CompletedNCT05844956Updated Feb 21, 2025

A Study of DZD8586 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (TAI-SHAN1)

A Phase 1/2 interventional study of DZD8586 in Lymphoma, Non-Hodgkin, sponsored by Dizal Pharmaceuticals. Completed at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-21.

Sponsored by Dizal Pharmaceuticals · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jun 2022, registered Apr 2023).
Phase
Phase 1/2
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study is designed to evaluate the safety, tolerability, pharmacokinetic profile, and antitumor efficacy of DZD8586 in participants with relapsed or refractory B-NHL.

02

Conditions studied

  • Lymphoma, Non-Hodgkin
03

In context

Lymphoma, Non-Hodgkin

2,043 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 309 are open to participants now.

This study's enrollment of 17 is below the median of 40 across 1,744 interventional studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

Dizal Pharmaceuticals is the lead sponsor of 39 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. All participants must provide a signed and dated written informed consent form prior to any study-specific procedures, sampling, and analysis.
  2. Male and female participants must be ≥ 18 years of age when signing the informed consent form.
  3. ECOG performance status score of 0 - 2 points and no disease deterioration in the past two weeks.
  4. Participants with relapsed or refractory B-NHL must be cytologically or histologically confirmed.
  5. Adequate bone marrow reserve (no blood transfusion within 7 days of the pre-enrollment visit, and no use of any stimulating factor or erythropoietin) and organ function.
  6. Participants should be able to follow the requirements of this study for medication use and follow-up.
  7. Female spouses (partners) of male participants who may become pregnant should use barrier contraception (such as condoms) during the participants' participation in the trial and within 6 months after the end of dosing. Male participants should also refrain from donating sperms during participation in the trial and within 6 months after the end of dosing.
  8. Female participants should use adequate contraception such as abstinence, tubal ligation, use of hormonal contraception with a known lower risk of drug-drug interaction [levonorgestrel intrauterine device (Mirena), medroxyprogesterone injection (Depo Provera)], copper-containing intrauterine device, and partner's vasectomy during the trial and within 3 months after the end of the trial.

Exclusion criteria

Exclusion Criteria:

  1. Have unresolved adverse drug reactions (except for alopecia) of higher than grade 1 (as defined by CTCAE v5.0) before the start of dosing in the study.
  2. A history of anticancer treatment within washout period as defined in the protocol.
  3. Participants with B-NHL other than CNSL who have central nervous system or intraocular lymphoma lesions.
  4. Participants with CNSL who have the following health conditions:

    1. Unable to cooperate with a lumbar puncture or cerebrospinal fluid test.
    2. Involvement of sites outside the CNS requiring systemic therapy.
    3. Participants with condition requiring systemic glucocorticoid therapy at a dose of > 8 mg/day (dexamethasone equivalent dose); or participants requiring immunosuppressant or biologic therapy.
  5. Active infectious diseases, including HBC, HCV, HIV, TB, etc.
  6. Abnormal heart and lung function.
  7. Refractory nausea and vomiting not well controlled by supportive care, chronic gastrointestinal disease, dysphagia, or previous surgical resection of bowel segments that may interfere with adequate drug absorption.
  8. Participants diagnosed with other malignancies apart from B-cell lymphoma within the past 5 years. However, participants may also be enrolled if the current evidence shows that the participant has been clinically cured and the investigator believes that the potential benefit of treatment with DZD8586 outweighs the potential risk.
  9. Participants with hypersensitivity to DZD8586 pharmaceutical excipients or other chemical analogs.
  10. Participants with serious or poorly controlled systemic diseases as judged by the investigator or other evidence, including poorly controlled hypertension and active bleeding disorders.
  11. Personnel involved in the planning and implementation of this study (only applicable to employees of the sponsor and study site).
  12. Female participants who are breastfeeding or pregnant.
  13. Participants who have taken DZD8586.
  14. Participants should not participate in the study if they are considered by the investigator to be unlikely to comply with study procedures, restrictions, and requirements.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    DZD8586

    Drug: DZD8586

Interventions

  • Daily dose of DZD8586, except for cycle 0 of Part A, in which a single dose of DZD8586 is administrated. Starting dose of DZD8586 is 10 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD8586.

06

What researchers measure

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

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

Secondary outcomes

  1. Plasma and cerebral spinal fluid concentrations of DZD8586

    Time frame: Through cycle 0 day 1 (8 days for Cycle 0, 28 days for Cycle 1, then 21 days for each subsequent cycle, up to Cycle 4)

  2. Objective Response Rate

    Time frame: Through cycle 3 day 1 for non-CNSL or Cycle 1 day 15 for CNSL(21 days for each subsequent cycle, assessed up to 2 years)

07

Study locations

6 sites
  • Research Site
    Beijing, Beijing Municipality 100142, China
  • Research Site
    Beijing, Beijing Municipality 100191, China
  • Research Site
    Guangzhou, Guangdong 510080, China
  • Research Site
    Zhengzhou, Henan 450008, China
  • Research Site
    Nanjing, Jiangsu 210000, China
  • Research Site
    Hangzhou, Zhejiang 310022, 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 Feb 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05844956
Responsible party
Sponsor
First posted
May 6, 2023
Start date
Jun 1, 2022
Primary completion
Feb 29, 2024
Completion
Feb 29, 2024
Last update
Feb 21, 2025

Study contacts

Anne Zhang
study director · Dizal Pharma

Oversight

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

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