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NOT YET RECRUITING
NCT07496229
PHASE1/PHASE2

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

Sponsor: Dizal Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

165

Start Date

2026-03

Completion Date

2029-12

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

GW5282 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.

DRUG

GW5282 combined with Golidocitinib

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

DRUG

Conventional 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