NCT07457177

Phaes Ⅱ Study of Golidocitinib-Pegaspargase-PD-1 Antibody First-Line for Advanced ENKTL

A Single-Arm, Open-Label Phase II Clinical Study to Evaluate the Safety and Efficacy of Golidocitinib in Combination With Pegaspargase and Anti-Programmed Death-1 (PD-1) Monoclonal Antibody as First-Line Therapy for Advanced Extranodal Natural Killer/T-Cell Lymphoma (ENKTL)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: LIANG WANG · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive non-Hodgkin lymphoma with poor prognosis in advanced stages, with a 5-year overall survival (OS) rate of less than 30% despite asparaginase-based regimens. Preclinical and clinical evidence suggests that PD-L1 is highly expressed in ENKTL, and PD-1 inhibitors show promising activity, while JAK1 inhibitors (e.g., golidocitinib) can reverse PD-1/PD-L1 inhibitor resistance and enhance anti-tumor immunity. This phase II study aims to evaluate the safety, tolerability, and anti-tumor activity of golidocitinib combined with pegaspargase and anti-PD-1 mAb as first-line therapy for advanced treatment-naive ENKTL, providing a novel therapeutic option for this patient population.

Conditions

• NK T-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Golidocitinib + Pegaspargase + Anti-PD-1 mAb	* Golidocitinib: 150 mg orally, once daily, continuous administration. * Pegaspargase: 2000-2500 IU/m² intravenously, once every 3 weeks (Day 1 of each cycle). * Anti-PD-1 mAb: Administered per product labeling, once every 3 weeks (Day 1 of each cycle). * Treatment Cycle: 3 weeks per cycle; combined treatment for up to 6 cycles. Patients achieving response may receive maintenance therapy with golidocitinib and/or anti-PD-1 mAb for up to 24 months.

Timeline

• Start date: 2026-02-10
• Primary completion: 2028-01-30
• Completion: 2030-01-30
• First posted: 2026-03-09
• Last updated: 2026-03-09