Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07457177
PHASE2

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

Sponsor: LIANG WANG

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-02-10

Completion Date

2030-01-30

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

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.