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RECRUITINGPHASE1/PHASE2

DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12)

A Phase Ib/II, Multicenter Study to Evaluate the Efficacy and Safety of DZD8586 Combination Therapy in Diffuse Large B-cell Lymphoma

NCT07059650•Dizal Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will treat patients with diffuse large B-cell lymphoma (DLBCL). It will assess the anti-tumor efficacy and safety of DZD8586 combination therapy by using objective response rate and the incidence and severity of adverse events. It will also measure the levels of DZD8586 in the body when combined with immunochemotherapy regimens.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Cohort 1:
•1. Patients with pathologically confirmed DLBCL who have not received prior anti-lymphoma therapy.
•2. Disease stage II to IV by Ann Arbor Classification.
•3. Life expectancy ≥ 12 months.
•Cohort 2, 3:
•1. Pathologically confirmed DLBCL patients who have received adequate first-line treatment containing CD20 monoclonal antibody and anthracyclines (such as R-CHOP-like regimen).
•2. Relapsed or refractory to first-line R-CHOP-like regimen.
•3. For patients who have received only one line of therapy, if the patient has not received autologous stem cell transplantation, the investigator needs to assess as unsuitable or the patient refuses intensive chemotherapy and hematopoietic stem cell transplantation.
•4. Life expectancy ≥ 6 months.
•Patients must also meet all of the following criteria to be included in this study:
+8 more criteria

Exclusion Criteria

•Cohort 2, 3:
•a. Hematopoietic stem cell transplantation, cell therapy, or gene therapy within 90 days prior to first dose. Radiation therapy within 14 days prior to first dose. Chemotherapy and small-molecule targeted therapy were not terminated within 5 half-lives before the first dose; macromolecule drug therapy (such as antibody therapy) was not terminated within 28 days before the first dose.
•All patients should not be included in this study if they have any of the following conditions:
•1. Indolent lymphoma-transformed DLBCL, primary mediastinal lymphoma, lymphoma involving the central nervous system, or DLBCL with MYC and BCL2 rearrangements.
•2. Prior use of BTK inhibitors.
•3. Vaccination with live attenuated vaccines or viral vector vaccines within 4 weeks prior to enrollment.
•4. Currently taking vitamin K antagonists, taking 2 or more antiplatelet/anticoagulant drugs at the same time, drugs/herbs or supplements known to potently induce or inhibit CYP3A enzyme activity, proton pump inhibitor drugs, anti-tumor traditional Chinese medicine or failing to meet the protocol-specified withdrawal time before administration in this study.
•5. Major surgery within 4 weeks or anticipated surgery after the start of this study. Or insufficiently recovered from any toxicity and/or complications of previous intervention.
•6. Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
•7. Active infectious diseases.
+6 more criteria

Locations (16)

Peking University Third Hospital

Beijing, China

Hunan Cancer Hospital

Changsha, China

West China Hospital of Sichuan University

Chengdu, China

Chongqing Cancer Hospital

Chongqing, China

Guangdong Provincial People's Hospital

Guangzhou, China

Sun Yat-sen University Cancer Center

Guangzhou, China

Zhujiang Hospital of Southern Medical University

Guangzhou, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

Anhui Provincial Cancer Hospital

Hefei, China

Shandong Cancer Hospital & Institute

Jinan, China

Key Dates

Start Date

August 19, 2025

Primary Completion Date

October 1, 2030

Completion Date

October 1, 2030

Last Updated

August 28, 2025

Enrollment

150

ESTIMATED participants

Conditions

Diffuse Large B-Cell Lymphoma

Interventions

DZD8586+R-CHOP

DRUG

DZD8586+R-GemOx

DRUG

DZD8586+BR

DRUG

Contacts

Mengling Zhong

CONTACT

+86-21-61095852 mengling.zhong@dizalpharma.com

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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: August 28, 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.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12)

Inclusion Criteria

Exclusion Criteria

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