NCT07496229

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Dizal Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• T-cell Lymphomas

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-15
• Primary completion: 2029-09-01
• Completion: 2029-12-01
• First posted: 2026-03-27
• Last updated: 2026-04-17

Locations

12 sites across 1 country: China