Lymphoma, Non-HodgkinPhase 1NCT05824585
DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
A Phase 1 study testing DZD8586 in people with Lymphoma, Non-Hodgkin, run by Dizal Pharmaceuticals at 5 sites in 2 countries.
Trial summary
This study will treat patients with B-NHL who have relapsed, progressed, or were intolerant to systemic therapy progressed following prior therapy. This study will help to understand what type of side effects may occur with the drug treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- DZD8586
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 May 2023to 30 Jun 2025
- Phase
- Phase 1
- 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
- Male or female participants who have provided ICF with age ≥ 18 yrs
- ECOG performance 0-2, no deterioration in the past 2 weeks
- Participants with relapsed or refractory B-NHL must have cytologically or histologically confirmed B-cell lymphoma
- Adequate bone marrow reserve and organ system functions
- Participants willing to comply with contraceptive restrictions
Who cannot join
- Any unresolved > Grade 1 adverse event at the time of starting study treatment with the exception of alopecia.
- Prior history of allogeneic hematopoietic stem cell transplantation
- Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, investigational small molecule therapy within 14 days. Monoclonal antibodies and antibody-drug conjugates within 28 days Radiation therapy within 1 weeks
- Live attenuated vaccines or viral vector vaccines within 4 weeks. Major surgery or significant traumatic injury within 4 weeks. History of stroke or intracranial hemorrhage within 6 months
- Participants with non-CNSL presence of CNS or intraocular lymphoma lesions.
- CNSL participants with systemic presence of lymphoma, unable to complete lumbar puncture, under systemic corticosteroids at a dose > 8 mg/day (dexamethasone equivalent dose) within 14 days or requiring immunosuppressive or biologic therapy."
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- Participants with infectious disease:
- Clinically significant cardiac disorders or abnormalities
- Another malignancy within 5 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.
- Refractory nausea and vomiting if not controlled by supportive therapy, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption
- Women who are breast feeding
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Australia4 sites
Research site
Albury, New South Wales
Research site
Ballarat, Victoria
Research site
Melbourne, Victoria
Research site
Perth, Western Australia
About this study
Official title: A Phase 1, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)
This study will treat patients with B-NHL who have relapsed, progressed, or were intolerant to systemic therapy progressed following prior therapy. This study 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 and assess its anti-cancer activity as monotherapy.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- DZD8586
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DZD8586Drug
DZD8586 treatment starting from 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD8586.
| Study group | Role | What they receive |
|---|---|---|
| DZD8586 | Experimental | Not described Receives: Drug: DZD8586 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Incidence of adverse events
Measured: 30 days after the last dose, assessed up to 2 years
Part B: Objective Response Rate assessed by investigators
Measured: assessed up to 2 years
Secondary outcomes (5)
Part A: Objective Response Rate assessed by investigators
Measured: assessed up to 2 years
Part A: Plasma and CSF concentration of DZD8586
Measured: through discontinuation of treatment up to 10 weeks
Part B: Duration of Response assessed by investigators
Measured: from date of first documented response until the date of documented progression, assessed up to 2 years
Part B: Incidence of adverse events
Measured: 30 days after the last dose, assessed up to 2 years
Part B: Plasma and CSF concentration of DZD8586
Measured: through discontinuation of treatment, 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 posted21 Apr 2023
- Study start15 May 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by Dizal PharmaceuticalsThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tianwei Zhang, Study director, Dizal Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824585
- Sponsor's protocol ID
- DZ2022B0002
- Status last verified
- Jun 2026
- First submitted
- 30 Mar 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)
- ClinicalTrials.gov ID
- NCT05824585
- Acronym / sponsor ID
- DZ2022B0002
- Conditions
- Lymphoma, Non-Hodgkin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 21 Apr 2023 (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 B-NHL who have relapsed, progressed, or were intolerant to systemic therapy progressed following prior therapy. This study 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 and assess its anti-cancer activity as monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DZD8586 | 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 (5 listed)
- Male or female participants who have provided ICF with age ≥ 18 yrs
- ECOG performance 0-2, no deterioration in the past 2 weeks
- Participants with relapsed or refractory B-NHL must have cytologically or histologically confirmed B-cell lymphoma
- Adequate bone marrow reserve and organ system functions
- Participants willing to comply with contraceptive restrictions
Key exclusion criteria (12 listed)
- Any unresolved > Grade 1 adverse event at the time of starting study treatment with the exception of alopecia.
- Prior history of allogeneic hematopoietic stem cell transplantation
- Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, investigational small molecule therapy within 14 days. Monoclonal antibodies and antibody-drug conjugates within 28 days Radiation therapy within 1 weeks
- Live attenuated vaccines or viral vector vaccines within 4 weeks. Major surgery or significant traumatic injury within 4 weeks. History of stroke or intracranial hemorrhage within 6 months
- Participants with non-CNSL presence of CNS or intraocular lymphoma lesions.
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 |
|---|---|---|
| DZD8586DZD8586 treatment starting from 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD8586. | Drug | DZD8586 |
Primary outcome
Part A: Incidence of adverse events
Time frame: 30 days after the last dose, assessed up to 2 years
Part B: Objective Response Rate assessed by investigators
Time frame: assessed up to 2 years
5 secondary outcomes
Part A: Objective Response Rate assessed by investigators
Time frame: assessed up to 2 years
Part A: Plasma and CSF concentration of DZD8586
Time frame: through discontinuation of treatment up to 10 weeks
Part B: Duration of Response assessed by investigators
Time frame: from date of first documented response until the date of documented progression, assessed up to 2 years
Part B: Incidence of adverse events
Time frame: 30 days after the last dose, assessed up to 2 years
Part B: Plasma and CSF concentration of DZD8586
Time frame: through discontinuation of treatment, 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 2 Jul 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.
Tianwei Zhang study director
Dizal Pharma
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DZD8586 in people with Lymphoma, Non-Hodgkin, run by Dizal Pharmaceuticals at 5 sites in 2 countries.
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 5 inclusion and 12 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 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Part A: Incidence of adverse events (time frame: 30 days after the last dose, assessed up to 2 years). The study lists 2 primary outcomes in all. 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 2 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.