NK T-Cell LymphomaPhase 2NCT07457177
Phaes Ⅱ Study of Golidocitinib-Pegaspargase-PD-1 Antibody First-Line for Advanced ENKTL
A Phase 2 study testing Golidocitinib + Pegaspargase + Anti-PD-1 mAb in people with NK T-Cell Lymphoma, run by LIANG WANG.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NK T-Cell Lymphoma
- What is being tested?
- Golidocitinib + Pegaspargase + Anti-PD-1 mAb
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2026to 30 Jan 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Measurable lesion: Lymph node ≥1.5 cm (long axis) × ≥1.0 cm (short axis); extranodal lesion ≥1.0 cm (long axis); if the only measurable lesion was previously irradiated, radiological progression after radiotherapy is required.
- Evaluable lesion: FDG-PET uptake higher than liver in lymph nodes or extranodal sites, consistent with lymphoma.
- Age ≥18 years at ICF signing.
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- Estimated life expectancy ≥12 weeks.
- ECOG performance status 0-2.
- Adequate organ and bone marrow function (without supportive care within 14 days):
- 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.
- Liver function: Total Bilirubin (TBIL) ≤1.5×ULN (≤3.0×ULN for Gilbert syndrome or liver involvement); Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×ULN (≤5.0×ULN for liver involvement).
- Renal function: Serum Creatinine (Cr) ≤1.5×ULN or Creatinine Clearance Rate (Ccr) ≥50 mL/min (Cockcroft-Gault method).
- Coagulation: International Normalized Ratio (INR) ≤1.5×ULN; Prothrombin Time (PT)/Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN (unless on anticoagulants with stable levels).
- Thyroid function: Thyroid Stimulating Hormone (TSH), Free Thyroxine (FT4), Free Triiodothyronine (FT3) within ±10% of normal range (non-autoimmune TSH abnormalities allowed).
- Left Ventricular Ejection Fraction (LVEF) ≥50% by MUGA or echocardiogram.
- Resolution of acute toxicities from prior therapies to ≤Grade 1 (CTCAE v5.0) or baseline; irreversible Grade 2 toxicities (e.g., neuropathy, alopecia) are allowed if not worsening.
- Women of Childbearing Potential (WOCBP) must have negative serum pregnancy test within 7 days of first dose; WOCBP and male partners must use effective contraception from ICF signing to 6 months after last study drug dose.
Who cannot join
- 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).
- Prior therapy:
- Allogeneic hematopoietic stem cell transplantation (HSCT) within 5 years (allowed if >5 years with no graft-versus-host disease).
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- Autologous HSCT within 3 months. Prior JAK/STAT3 inhibitors. Concurrent use of strong CYP3A inducers/inhibitors (unable to discontinue 1 week before first dose).
- Concurrent vitamin K antagonists, antiplatelet agents, or anticoagulants (unable to discontinue 1 week before first dose).
- Systemic glucocorticoids or immunosuppressants within 14 days (local/ocular/inhaled/nasal glucocorticoids or short-term ≤7 days for prophylaxis allowed).
- Cytotoxic chemotherapy within 21 days. Systemic anti-tumor therapy (including mAbs, immunotherapy) within 4 weeks. Major surgery within 6 weeks or radiotherapy within 90 days. Toxin/isotope-antibody conjugates within 10 weeks. Investigational drugs within 30 days.
- Active infections:
- Active/latent tuberculosis (PPD positive with induration >10 mm or radiological evidence).
- HIV infection. Active chronic hepatitis B (HBsAg positive with HBV DNA >2500 copies/mL or 500 IU/mL) or hepatitis C (HCV RNA positive). HBV carriers with controlled HBV DNA and cured HCV are allowed; HBsAg-positive patients require monthly HBV DNA monitoring and prophylactic entecavir until 12 months after anti-tumor 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).
- Uncontrolled cardiac disease: NYHA Class >2 heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmias requiring treatment.
- Prior interstitial lung disease (except radiation-induced asymptomatic disease).
- Unresolved Grade >1 AEs (except alopecia) from prior therapies.
- Hypersensitivity to golidocitinib, pegaspargase, anti-PD-1 mAb, or excipients; history of Grade ≥3 hypersensitivity to mAbs or uncontrolled allergic asthma.
- Refractory nausea/vomiting, chronic gastrointestinal disease, dysphagia, or prior bowel resection affecting drug absorption.
- Pregnant or lactating women; unwilling to use contraception.
- Psychiatric illness or inability to provide informed consent.
- Investigator-determined unsuitability for study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm, Open-Label Phase II Clinical Study to Evaluate the Safety and Efficacy of Golidocitinib in Combination With Pegaspargase and Anti-Programmed Death-1 (PD-1) Monoclonal Antibody as First-Line Therapy for Advanced Extranodal Natural Killer/T-Cell Lymphoma (ENKTL)
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.
- Conditions
- NK T-Cell Lymphoma
- Being tested
- Golidocitinib + Pegaspargase + Anti-PD-1 mAb
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Golidocitinib + Pegaspargase + Anti-PD-1 mAbDrug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Golidocitinib + Pegaspargase + Anti-PD-1 mAb | Experimental | Not described Receives: Drug: Golidocitinib + Pegaspargase + Anti-PD-1 mAb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (CRR)
Measured: 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 (5)
Overall Response Rate (ORR)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Throughout treatment and 28-day safety follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start10 Feb 2026 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NK T-Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LIANG WANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LIANG WANG, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457177
- Sponsor's protocol ID
- TREC2025-KY247
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label Phase II Clinical Study to Evaluate the Safety and Efficacy of Golidocitinib in Combination With Pegaspargase and Anti-Programmed Death-1 (PD-1) Monoclonal Antibody as First-Line Therapy for Advanced Extranodal Natural Killer/T-Cell Lymphoma (ENKTL)
- ClinicalTrials.gov ID
- NCT07457177
- Acronym / sponsor ID
- TREC2025-KY247
- Conditions
- NK T-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- LIANG WANGUniversity, hospital or other
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Golidocitinib + Pegaspargase + Anti-PD-1 mAb | Experimental | Drug: Golidocitinib + Pegaspargase + Anti-PD-1 mAb |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- Measurable lesion: Lymph node ≥1.5 cm (long axis) × ≥1.0 cm (short axis); extranodal lesion ≥1.0 cm (long axis); if the only measurable lesion was previously irradiated, radiological progression after radiotherapy is required.
- Evaluable lesion: FDG-PET uptake higher than liver in lymph nodes or extranodal sites, consistent with lymphoma.
Key exclusion criteria (23 listed)
- 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).
- Prior therapy:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Golidocitinib + Pegaspargase + Anti-PD-1 mAb* 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. | Drug | Golidocitinib + Pegaspargase + Anti-PD-1 mAb |
Primary outcome
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).
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Golidocitinib + Pegaspargase + Anti-PD-1 mAb in people with NK T-Cell Lymphoma, run by LIANG WANG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Wang (+86 15001108693, wangliangtrhos@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.