RecruitingPhase 1Phase 2NCT07496229

Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3)

A Phase I/II Clinical Study to Evaluate the Efficacy and Safety of GW5282 in Combination With Golidocitinib in the Treatment of T-Cell Lymphoma


Sponsor

Dizal Pharmaceuticals

Enrollment

165 participants

Start Date

Apr 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 1/2 open-label study to evaluate GW5282 in combination with golidocitinib (G2 regimen) for the treatment of T-cell lymphoma. In the first phase of the study, the maximum tolerated dose will be determined through dose escalation; in the second phase, the potential therapeutic advantages of the novel combination therapy over the conventional CHOP regimen will be preliminarily assessed through a randomized controlled design.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Conventional CHOP regimen, a drug called GW5282 combined with Golidocitinib, and others for people with t-cell lymphomas. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGGW5282 combined with Golidocitinib

GW5282 and Golidocitinib will be administered in combination as twice daily (BID) and once daily (QD), respectively. The starting dose will be GW5282 40 mg BID combined with golidocitinib 150 mg QD. If tolerated, the dose of GW5282 will be subsequently escalated.

DRUGGW5282 combined with Golidocitinib

GW5282 and Golidocitinib will be administered at the doses determined during escalation part.

DRUGConventional CHOP regimen

CHOP regimen includes the administrations of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.


Locations(12)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Fudan University Shanghai Cancer Center

Shanghai, China

Shanxi Provincial Cancer Hospital

Taiyuan, China

Henan Cancer Hospital

Zhengzhou, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07496229


Related Trials