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

WITHDRAWNPHASE1/PHASE2

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

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

NCT04148742•Dizal Pharmaceuticals

View on ClinicalTrials.gov

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.

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

•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.
+10 more criteria

Locations (2)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Nanjing, China

Jiangsu Province Hospital - Haematology

Nanjing, China

Key Dates

Start Date

August 1, 2021

Primary Completion Date

July 1, 2023

Completion Date

July 1, 2023

Last Updated

February 25, 2025

Conditions

Non-Hodgkin's B-cell Lymphoma

Interventions

DZD9008

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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