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WithdrawnNCT04148742Updated Feb 25, 2025

Assessing an Oral Bruton Tyrosine Kinase Inhibitor, DZD9008 in Patients Who Have Non-Hodgkin B-cell Lymphoma (WU-KONG3)

A Phase 1/2 interventional study of DZD9008 in Non-Hodgkin's B-cell Lymphoma, sponsored by Dizal Pharmaceuticals. Withdrawn at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-25.

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

Why this study was withdrawn
Clinical development strategy adjustment, non-safety reason
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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. 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).

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Conditions studied

  • Non-Hodgkin's B-cell Lymphoma
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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

Browse Lymphoma 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.

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Who can participate

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

  • 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.
  • 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.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    daily dose of DZD9008

    daily dose of DZD9008

    Drug: DZD9008

Interventions

  • DrugDZD9008

    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.

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What researchers measure

Primary outcomes

  1. Part A: Incidence of Treatment-Emergent Adverse Events

    Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0

    Time frame: Through study completion, an average of 1.5 years

  2. Part B: objective response rate (ORR)

    Time frame: Through study completion, an average of 1.5 years

Secondary outcomes

  1. Maximum Plasma DZD9008 concentration

    Time frame: up to 16 weeks

  2. Plasma DZD9008 concentration- Area Under the Curve

    Time frame: up to 16 weeks

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Study locations

2 sites
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
    Nanjing, China
  • Jiangsu Province Hospital - Haematology
    Nanjing, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04148742
Lead sponsor
Dizal Pharmaceuticals
Responsible party
Sponsor
First posted
Nov 1, 2019
Start date
Aug 2021 (estimated)
Primary completion
Jul 2023 (estimated)
Completion
Jul 2023 (estimated)
Last update
Feb 25, 2025

Study contacts

Jianyong Li
principal investigator · The First Affiliated Hospital with Nanjing Medical University

Oversight

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

Not currently enrolling

This study is withdrawn, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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