Phaes Ⅱ Study of Golidocitinib-Pegaspargase-PD-1 Antibody First-Line for Advanced ENKTL
ConditionNK T-Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLIANG WANG
About this trial
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.
Eligibility criteria
Qualifiers
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.
Age ≥18 years at ICF signing.
Estimated life expectancy ≥12 weeks.
Disqualifiers
Aggressive NK-cell leukemia or ENKTL in leukemic phase.
Concurrent hemophagocytic syndrome.
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).
Trial design
Treatments tested in this trial
- Golidocitinib + Pegaspargase + Anti-PD-1 mAb
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
LIANG WANG
Lead sponsor
Beijing Tongren Hospital
Sponsor institution
Source ClinicalTrials.gov