Natural Killer/T-cell LymphomaPhase 2NCT07380984
PD-1 Antibody-based Therapy With Concurrent RT for Early-stage NKTCL
A Phase 2 study testing PD-1 antibody, radiotherapy and Chidamide in people with Natural Killer/T-cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
Natural killer/T-cell lymphoma (nasal type) is a mature T/NK-cell lymphoma closely associated with Epstein-Barr virus (EBV), with a high prevalence among populations in Asia and South America. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Natural Killer/T-cell Lymphoma
- What is being tested?
- PD-1 antibody, radiotherapy and Chidamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- Mar 2026to Feb 2029
- 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
- The subject has histopathologically confirmed extranodal NK/T-cell lymphoma, nasal type (according to the 2022 WHO classification).
- No prior history of anti-lymphoma therapy.
- Age ≥ 18 years.
- Life expectancy > 3 months.
- Ann Arbor stage I-II.
- At least one measurable/evaluable disease site confirmed by diagnostic biopsy prior to the initiation of treatment.
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Signed informed consent form (ICF).
- Willingness and ability to comply with the study protocol.
- Sufficient bone marrow, hepatic, and renal function, defined as:
- Absolute neutrophil count (ANC) > 1,000/μL
- Platelet count > 50,000/μL
- Hemoglobin > 9 g/dL
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3× upper limit of normal (ULN)
- Serum total bilirubin < 1.5 × ULN (patients with Gilbert's syndrome are eligible)
- Serum creatinine < 2 × ULN or creatinine clearance > 50 mL/min
- Availability of tumor tissue samples (preferably fresh tissue; archived tissue samples are acceptable).
- For women of childbearing potential, agreement to use adequate contraception to avoid pregnancy during the study treatment period.
- For male, agreement to remain abstinent or use a barrier method of contraception.
Who cannot join
- Advanced-stage disease (Ann Arbor Stage III-IV).
- Nonnasal-type NKTCL.
- A history of autoimmune disease requiring systemic treatment (i.e., with disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within the past 2 years, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody-associated vasculopathy, granulomatosis with polyangiitis (Wegener's), Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- The following conditions are permissible for enrollment: patients with autoimmune hypothyroidism or type 1 diabetes receiving stable treatment; hormone replacement therapy (e.g., levothyroxine, insulin, or supplementation with physiological hormones for adrenal or pituitary insufficiency) is not considered systemic therapy and is allowed.
- A history of other invasive malignancies within the past 3 years that has not been treated with curative intent or is currently receiving anticancer therapy (including hormonal therapy for breast or prostate cancer).
- A history of (non-infectious) pneumonia requiring corticosteroid therapy; or clinical evidence of interstitial lung disease or active, non-infectious pneumonia.
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- Active infections requiring systemic treatment, including:
- A known history of active tuberculosis;
- Positive results for HBsAg, HCV, or HIV; HBV seropositivity is permitted only if HBV DNA < 1000 IU/mL;
- Active viral infections other than hepatitis B and C (e.g., herpes zoster).
- Severe cardiovascular disease, including myocardial infarction, unstable arrhythmia, or unstable angina occurring within the past 3 months.
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
- Administration of live-attenuated vaccines within 4 weeks prior to the initiation of study treatment; patients are prohibited from receiving live-attenuated vaccines during the study period, including influenza vaccines.
- Use of systemic immunosuppressive agents within 2 weeks prior to the initiation of study treatment, or planned use of such agents during the study period, including cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) drugs.
- Evidence of central nervous system involvement.
- A history of allogeneic tissue/solid organ transplantation.
- A history of severe hypersensitivity reactions (Grade ≥ 3) to PD-1 monoclonal antibodies and/or their excipients, or to gorlitinib and/or its excipients.
- Any other factors judged by the investigator to potentially affect compliance with the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai
+862164370045
About this study
Official title: A Prospective Study to Evaluate the Efficacy and Safety of PD-1 Monoclonal Antibody-based Stratified Targeted Therapy Combined With Concurrent Radiotherapy for Patients With Treatment-naive Early-stage Nasal-type NK/T-cell Lymphoma
Natural killer/T-cell lymphoma (nasal type) is a mature T/NK-cell lymphoma closely associated with Epstein-Barr virus (EBV), with a high prevalence among populations in Asia and South America. It primarily occurs at extranodal sites, including the nasal/paranasal regions, skin, gastrointestinal tract, and other organs. This study focuses on previously untreated patients with early-stage NKTCL (nasal type), exploring a response-adapted comprehensive therapeutic strategy that combines PD-1 monoclonal antibody-based stratified targeted therapy with concurrent radiotherapy. The aim is to provide integrated management for early-stage extranodal NK/T-cell lymphoma (nasal type), and reduce toxicity while improving overall treatment outcomes for patients.
- Conditions
- Natural Killer/T-cell Lymphoma
- Being tested
- PD-1 antibody, radiotherapy, Chidamide, golidocitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 antibodyDrug
Administration of PD-1 mAb will start on Day 1 of radiotherapy (C1D1) at a dose of 200 mg via intravenous infusion over 30 minutes or longer, once every 3 weeks, cycle 1 - cycle 6
radiotherapyRadiation
Concurrent standard involved-site radiotherapy (ISRT)
ChidamideDrug
The dosage of chidamide will follow a dose-escalation design: 20 mg twice weekly (biw) in the first stage, then escalated to 30 mg biw, using the Bayesian Optimal Interval (BOIN) design to determine the recommended dose, followed by dose expansion in the second stage, every 3 weeks, cycle 4 - cycle 6.
golidocitinibDrug
Golidocitinib will be administered at a dose of 150 mg once daily (qd), every 3 weeks, cycle 4 - cycle 6.
| Study group | Role | What they receive |
|---|---|---|
| PD-1 antibody monotherapy group | Experimental | Patients will receive concurrent standard involved-site radiotherapy (ISRT) and PD-1 monoclonal antibody therapy. Administration of PD-1 mAb will start on Day 1 of radiotherapy (C1D1) at a dose of 200 mg via intravenous infusion over 30 minutes or longer, once every 3 weeks. After the 3rd cycle, patients will undergo re-evaluation (PET scan and plasma EBV DNA detection). Patients with an interim Deauville score of 1-3 and negative EBV DNA will continue to receive 3 cycles of PD-1 monoclonal antibody therapy. Receives: Drug: PD-1 antibody; Radiation: radiotherapy |
| The multi-drug combination group | Experimental | Patients will receive concurrent standard involved-site radiotherapy (ISRT) and PD-1 monoclonal antibody therapy. Administration of PD-1 mAb will start on Day 1 of radiotherapy (C1D1) at a dose of 200 mg via intravenous infusion over 30 minutes or longer, once every 3 weeks. After the 3rd cycle, patients will undergo re-evaluation (PET scan and plasma EBV DNA detection). Patients with an interim Deauville score of 4-5 or positive EBV DNA will subsequently receive 3 cycles of a combination regimen of PD-1 antibody, chidamide and golidocitinib. Receives: Drug: PD-1 antibody; Radiation: radiotherapy; Drug: Chidamide; Drug: golidocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival rate
Progression-free survival is defined as the time from registration to the first occurrence of disease progression or relapse, using 2014 Lugano criteria, or death from any cause. For patients who received subsequent treatment after the interim assessment, the endpoint shall be defined by the event first occurring after the initiation of subsequent treatment.
Measured: Baseline up to data cut-off (up to 24 months).
Secondary outcomes (7)
Complete Response Rate
The proportion of patients with complete response after 3 cycles, 6 cycles from treatment start, according to the 2014 Lugano Response Criteria.
Measured: At the end of cycle 3, cycle 6 after treatment start.
Overall Response Rate
The proportion of patients with complete and partial response after 3 cycles, 6 cycles from treatment start, according to the 2014 Lugano Response Criteria.
Measured: At the end of cycle 3, cycle 6 after treatment start.
2-year overall survival rate
Overall survival is defined as the time from registration to death from any cause.
Measured: Baseline up to data cut-off (up to 24 months).
2-year event-free survival rate
Event-free survival is defined as the time from registration to event occurrence. An event is defined as one of the following: disease progression, death from any cause, discontinuation of the protocol-specified treatment due to adverse events, or initiation of a new anti-lymphoma therapy.
Measured: Baseline up to data cut-off (up to 24 months).
Duration of Response
Duration of response is defined as the period from the first response to first evidence of disease progression, relapse or death of any cause.
Measured: From enrollment to study completion (up to approximately 24 months).
Treatment-Related Adverse Events rate
Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.
Measured: From enrollment to study completion (up to approximately 24 months).
The change of plasma EB virus DNA load
The change of plasma EB virus DNA load during the treatment
Measured: Baseline up to data cut-off (up to 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Natural Killer/T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380984
- Sponsor's protocol ID
- NOVEL-02
- Status last verified
- Mar 2026
- First submitted
- 24 Jan 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Efficacy and Safety of PD-1 Monoclonal Antibody-based Stratified Targeted Therapy Combined With Concurrent Radiotherapy for Patients With Treatment-naive Early-stage Nasal-type NK/T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT07380984
- Acronym / sponsor ID
- NOVEL-02
- Conditions
- Natural Killer/T-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 2 Feb 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.
Natural killer/T-cell lymphoma (nasal type) is a mature T/NK-cell lymphoma closely associated with Epstein-Barr virus (EBV), with a high prevalence among populations in Asia and South America. It primarily occurs at extranodal sites, including the nasal/paranasal regions, skin, gastrointestinal tract, and other organs. This study focuses on previously untreated patients with early-stage NKTCL (nasal type), exploring a response-adapted comprehensive therapeutic strategy that combines PD-1 monoclonal antibody-based stratified targeted therapy with concurrent radiotherapy. The aim is to provide integrated management for early-stage extranodal NK/T-cell lymphoma (nasal type), and reduce toxicity while improving overall treatment outcomes for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-1 antibody monotherapy group | Experimental | Drug: PD-1 antibody, Radiation: radiotherapyPatients will receive concurrent standard involved-site radiotherapy (ISRT) and PD-1 monoclonal antibody therapy. Administration of PD-1 mAb will start on Day 1 of radiotherapy (C1D1) at a dose of 200 mg via intravenous infusion over 30 minutes or longer, once every 3 weeks. After the 3rd cycle, patients will undergo re-evaluation (PET scan and plasma EBV DNA detection). Patients with an interim Deauville score of 1-3 and negative EBV DNA will continue to receive 3 cycles of PD-1 monoclonal antibody therapy. |
| The multi-drug combination group | Experimental | Drug: PD-1 antibody, Radiation: radiotherapy, Drug: Chidamide, Drug: golidocitinibPatients will receive concurrent standard involved-site radiotherapy (ISRT) and PD-1 monoclonal antibody therapy. Administration of PD-1 mAb will start on Day 1 of radiotherapy (C1D1) at a dose of 200 mg via intravenous infusion over 30 minutes or longer, once every 3 weeks. After the 3rd cycle, patients will undergo re-evaluation (PET scan and plasma EBV DNA detection). Patients with an interim Deauville score of 4-5 or positive EBV DNA will subsequently receive 3 cycles of a combination regimen of PD-1 antibody, chidamide and golidocitinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- The subject has histopathologically confirmed extranodal NK/T-cell lymphoma, nasal type (according to the 2022 WHO classification).
- No prior history of anti-lymphoma therapy.
- Age ≥ 18 years.
- Life expectancy > 3 months.
- Ann Arbor stage I-II.
Key exclusion criteria (18 listed)
- Advanced-stage disease (Ann Arbor Stage III-IV).
- Nonnasal-type NKTCL.
- A history of autoimmune disease requiring systemic treatment (i.e., with disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within the past 2 years, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody-associated vasculopathy, granulomatosis with polyangiitis (Wegener's), Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- The following conditions are permissible for enrollment: patients with autoimmune hypothyroidism or type 1 diabetes receiving stable treatment; hormone replacement therapy (e.g., levothyroxine, insulin, or supplementation with physiological hormones for adrenal or pituitary insufficiency) is not considered systemic therapy and is allowed.
- A history of other invasive malignancies within the past 3 years that has not been treated with curative intent or is currently receiving anticancer therapy (including hormonal therapy for breast or prostate cancer).
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 |
|---|---|---|
| PD-1 antibodyAdministration of PD-1 mAb will start on Day 1 of radiotherapy (C1D1) at a dose of 200 mg via intravenous infusion over 30 minutes or longer, once every 3 weeks, cycle 1 - cycle 6 | Drug | PD-1 antibody monotherapy group, The multi-drug combination group |
| radiotherapyConcurrent standard involved-site radiotherapy (ISRT) | Radiation | PD-1 antibody monotherapy group, The multi-drug combination group |
| ChidamideThe dosage of chidamide will follow a dose-escalation design: 20 mg twice weekly (biw) in the first stage, then escalated to 30 mg biw, using the Bayesian Optimal Interval (BOIN) design to determine the recommended dose, followed by dose expansion in the second stage, every 3 weeks, cycle 4 - cycle 6. | Drug | The multi-drug combination group |
| golidocitinibGolidocitinib will be administered at a dose of 150 mg once daily (qd), every 3 weeks, cycle 4 - cycle 6. | Drug | The multi-drug combination group |
Primary outcome
2-year progression-free survival rate
Time frame: Baseline up to data cut-off (up to 24 months).
Progression-free survival is defined as the time from registration to the first occurrence of disease progression or relapse, using 2014 Lugano criteria, or death from any cause. For patients who received subsequent treatment after the interim assessment, the endpoint shall be defined by the event first occurring after the initiation of subsequent treatment.
7 secondary outcomes
Complete Response Rate
Time frame: At the end of cycle 3, cycle 6 after treatment start.
Overall Response Rate
Time frame: At the end of cycle 3, cycle 6 after treatment start.
2-year overall survival rate
Time frame: Baseline up to data cut-off (up to 24 months).
2-year event-free survival rate
Time frame: Baseline up to data cut-off (up to 24 months).
Duration of Response
Time frame: From enrollment to study completion (up to approximately 24 months).
Treatment-Related Adverse Events rate
Time frame: From enrollment to study completion (up to approximately 24 months).
The change of plasma EB virus DNA load
Time frame: Baseline up to data cut-off (up to 24 months).
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 20 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD-1 antibody, radiotherapy and Chidamide in people with Natural Killer/T-cell Lymphoma, run by Ruijin Hospital at 1 site in China.
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 19 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Weili Zhao (+610707 +862164370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression-free survival rate (time frame: Baseline up to data cut-off (up to 24 months).). 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 20 Mar 2026.