Phaes Ⅱ Study of Golidocitinib-Pegaspargase-PD-1 Antibody First-Line for Advanced ENKTL (NCT07457177) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phaes Ⅱ Study of Golidocitinib-Pegaspargase-PD-1 Antibody First-Line for Advanced ENKTL
40 participantsStarted 2026-02-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntarily provides written informed consent (ICF) and agrees to comply with study procedures.
✓. Histopathologically confirmed ENKTL per the 2022 WHO Classification of Lymphoid Neoplasms, with no prior systemic anti-lymphoma therapy.
✓. At least one measurable or evaluable lesion per 2014 Lugano Classification:
✓. Age ≥18 years at ICF signing.
✓. Estimated life expectancy ≥12 weeks.
✓. ECOG performance status 0-2.
✓. Hematology: Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L (≥0.5×10⁹/L with bone marrow involvement); Platelet (PLT) ≥100×10⁹/L (≥50×10⁹/L with bone marrow involvement); Hemoglobin (HGB) ≥8.0 g/dL.
✓. Left Ventricular Ejection Fraction (LVEF) ≥50% by MUGA or echocardiogram.
Exclusion criteria
✕. Aggressive NK-cell leukemia or ENKTL in leukemic phase.
What they're measuring
1
Complete Response Rate (CRR)
Timeframe: At the end of 6 cycles of combined treatment (each cycle is 21 days, total 18 weeks from the first dose of treatment).
✕. Lymphoma involvement of central nervous system (CNS) or meninges.
✕. History of other malignancies within 5 years (except cured localized tumors: e.g., basal/squamous cell skin cancer, in situ prostate/cervical/breast cancer).
✕. Prior therapy:
✕. Active viral infections (e.g., herpes zoster) or bacterial infections requiring IV/oral antimicrobials within 30 days (including pneumonia).
✕. Active autoimmune diseases requiring systemic therapy within 2 years (allowed if inactive for 2 years; hormone replacement therapy for hypothyroidism/diabetes is allowed).