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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
* 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.
Complete Response Rate (CRR)
Time frame: At the end of 6 cycles of combined treatment (each cycle is 21 days, total 18 weeks from the first dose of treatment).
Overall Response Rate (ORR)
Time frame: At the end of 6 cycles of combined treatment (each cycle is 21 days, total 18 weeks from the first dose of treatment).
Duration of Response (DoR)
Time frame: From the first date of confirmed complete response (CR) or partial response (PR) to the date of first documented disease progression or recurrence, assessed up to 24 months from study enrollment.
Progression-Free Survival (PFS)
Time frame: From the date of study enrollment to the date of first documented progressive disease (PD) or death from any cause (whichever occurs first), assessed up to 24 months from study enrollment.
Overall Survival (OS)
Time frame: From the date of study enrollment to the date of death from any cause, assessed up to 24 months from study enrollment.
Incidence of AEs/SAEs/irAEs
Time frame: Throughout treatment and 28-day safety follow-up
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