Non-Hodgkin's B-cell LymphomaPhase 1/2NCT04148742
Assessing an Oral Bruton Tyrosine Kinase Inhibitor, DZD9008 in Patients Who Have Non-Hodgkin B-cell Lymphoma (WU-KONG3)
A Phase 1/2 study testing DZD9008 in people with Non-Hodgkin's B-cell Lymphoma, run by Dizal Pharmaceuticals at 2 sites in China.
Trial summary
This study will treat patients with non-Hodgkin B-cell lymphoma who have relapsed from, refractory or intolerant to prior therapy. This study will help 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
- Non-Hodgkin's B-cell Lymphoma
- What is being tested?
- DZD9008
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2021to Jul 2023
- Phase
- Phase 1/2
- 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
- Aged at least 18 years old.
- Patients must be willing and able to participate in all required evaluations and procedures.
- Patients must be able to provide a signed written informed consent.
- With documented histologically confirmed diagnosis of CLL/SLL, MCL or MZL and have least 1 measurable site of disease. Subjects must have relapsed, or are refractory or intolerant to >= 2 lines of prior therapy, and without preferred alternative treatment as judged by investigator. For Part B, subjects should be either BTK inhibitor treatment naive or intolerant to prior BTK inhibitor within 6 months on treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Predicted life expectancy ≥ 12 weeks.
- Adequate organ system functions.
Who cannot join
- Prior malignancy requires active treatment within 2 to 3 years.
- A life-threatening illness, medical condition or organ system dysfunction.
- Radiotherapy with a limited field of radiation for palliation within 1 week of the screening.
- Major surgery within 4 weeks before screening.
- Prior treatment with any onco-immunotherapy within 4 weeks before screening.
- Subjects require immediate cytoreduction.
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- Any history of Richter's transformation.
- Central nervous system (CNS) involvement unless previous treated and asymptomatic.
- Requires anticoagulation therapy with Warfarin, heparin.
- Known history of human immunodeficiency virus (HIV); Positive Hepatitis B surface antigen (HbsAg) or positive HCV antibodies; any other uncontrolled active systemic infection.
- Any of the following cardiac criteria: (1) mean resting corrected QT interval (QTcF) > 470 msec obtained from 3 electrocardiograms (ECGs). (2) prior history of atrial fibrillation. (3) any factors that increase the risk of QTcF prolongation, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
- History of stroke or intracranial haemorrhage.
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.
- History of hypersensitivity.
- Receiving (or unable to stop using) medications or herbal supplements known to be potent inhibitors or inducers of CYP3A.
- Grapefruit, grapefruit juice, and orange marmalade (made with Seville oranges) should be excluded.
- Women who are pregnant or breast feeding
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
- Previous allogenic bone marrow transplant.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Nanjing
Jiangsu Province Hospital - Haematology
Nanjing
About this study
Official title: A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Non-Hodgkin B-cell Lymphoma
This study will treat patients with non-Hodgkin B-cell lymphoma who have relapsed from, refractory or intolerant to prior therapy. This study will help understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.
Read the detailed description
A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients with Non-Hodgkin B-cell Lymphoma. This study includes dose escalation (Part A) and dose expansion (Part B).
- Conditions
- Non-Hodgkin's B-cell Lymphoma
- Being tested
- DZD9008
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DZD9008Drug
Daily dose of DZD9008, except for cycle 0 of Part A, in which a single dose of DZD9008 is administrated. Starting dose of DZD9008 is 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD9008.
| Study group | Role | What they receive |
|---|---|---|
| daily dose of DZD9008 | Experimental | daily dose of DZD9008 Receives: Drug: DZD9008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
Measured: Through study completion, an average of 1.5 years
Part B: objective response rate (ORR)
Measured: Through study completion, an average of 1.5 years
Secondary outcomes (2)
Maximum Plasma DZD9008 concentration
Measured: up to 16 weeks
Plasma DZD9008 concentration- Area Under the Curve
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study startAug 2021 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Why it stopped: Clinical development strategy adjustment, non-safety reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's B-cell LymphomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianyong Li, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148742
- Sponsor's protocol ID
- DZ2019B0001
- Status last verified
- Feb 2025
- First submitted
- 28 Oct 2019
- Last updated
- 25 Feb 2025
- 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 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Non-Hodgkin B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04148742
- Acronym / sponsor ID
- DZ2019B0001
- Conditions
- Non-Hodgkin's B-cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Clinical development strategy adjustment, non-safety reason
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2021 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 1 Nov 2019 (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 non-Hodgkin B-cell lymphoma who have relapsed from, refractory or intolerant to prior therapy. This study will help understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.
Detailed description
A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients with Non-Hodgkin B-cell Lymphoma. This study includes dose escalation (Part A) and dose expansion (Part B).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| daily dose of DZD9008 | Experimental | Drug: DZD9008daily dose of DZD9008 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged at least 18 years old.
- Patients must be willing and able to participate in all required evaluations and procedures.
- Patients must be able to provide a signed written informed consent.
- With documented histologically confirmed diagnosis of CLL/SLL, MCL or MZL and have least 1 measurable site of disease. Subjects must have relapsed, or are refractory or intolerant to >= 2 lines of prior therapy, and without preferred alternative treatment as judged by investigator. For Part B, subjects should be either BTK inhibitor treatment naive or intolerant to prior BTK inhibitor within 6 months on treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Key exclusion criteria (20 listed)
- Prior malignancy requires active treatment within 2 to 3 years.
- A life-threatening illness, medical condition or organ system dysfunction.
- Radiotherapy with a limited field of radiation for palliation within 1 week of the screening.
- Major surgery within 4 weeks before screening.
- Prior treatment with any onco-immunotherapy within 4 weeks before screening.
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 |
|---|---|---|
| DZD9008Daily dose of DZD9008, except for cycle 0 of Part A, in which a single dose of DZD9008 is administrated. Starting dose of DZD9008 is 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD9008. | Drug | daily dose of DZD9008 |
Primary outcome
Part A: Incidence of Treatment-Emergent Adverse Events
Time frame: Through study completion, an average of 1.5 years
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
Part B: objective response rate (ORR)
Time frame: Through study completion, an average of 1.5 years
2 secondary outcomes
Maximum Plasma DZD9008 concentration
Time frame: up to 16 weeks
Plasma DZD9008 concentration- Area Under the Curve
Time frame: up to 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- 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.
Jianyong Li principal investigator
The First Affiliated Hospital with Nanjing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DZD9008 in people with Non-Hodgkin's B-cell Lymphoma, run by Dizal Pharmaceuticals at 2 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 7 inclusion and 20 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: withdrawn, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined 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.
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 was withdrawn before enrolling participants, so there are no results.
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 Treatment-Emergent Adverse Events (time frame: Through study completion, an average of 1.5 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 25 Feb 2025.