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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Golidocitinib + Pegaspargase + Anti-PD-1 mAb

    Drug

    * 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Golidocitinib + Pegaspargase + Anti-PD-1 mAbExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Secondary outcomes

1

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).
2

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.
3

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.
4

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LIANG WANG

Lead sponsor

Beijing Tongren Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: