drugset / Trial / NCT07457177
Phaes Ⅱ Study of Golidocitinib-Pegaspargase-PD-1 Antibody First-Line for Advanced ENKTL
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-02-10
- Primary completion
- 2028-01-30
- Completion
- 2030-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Golidocitinib | Small molecule | 150 mg | Oral |
| Subject | Pegaspargase | Protein / enzyme biologic | 2000 unknown | Intravenous |
| Subject | Pegaspargase | Protein / enzyme biologic | 2500 unknown | Intravenous |