Extranodal NK/T-cell LymphomaPhase 1/2EpiRev-NKTNCT07502768
Tislelizumab Plus Zeprumetostat for Relapsed or Refractory NK/T-Cell Lymphoma
A Phase 1/2 study testing Tislelizumab and Zeprumetostat in people with Extranodal NK/T-cell Lymphoma and NK/T-cell Lymphoma, run by Rong Tao at 1 site in China.
Trial summary
This is a multicenter, open-label, phase Ib/II study evaluating tislelizumab in combination with zeprumetostat (SHR2554) in patients with relapsed or refractory NK/T-cell lymphoma after at least one prior asparaginase-based chemotherapy-containing regimen, with or without radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma, NK/T-cell Lymphoma, Relapsed or Refractory NK/T-Cell Lymphoma
- What is being tested?
- Tislelizumab and Zeprumetostat
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 30 Dec 2028
- Phase
- Phase 1/2
- 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
- Age 18 years or older.
- Pathologically confirmed NK/T-cell lymphoma.
- Relapsed or refractory disease after at least 1 prior asparaginase-based chemotherapy-containing regimen, with or without radiotherapy.
- At least 1 measurable or evaluable lesion according to Lugano 2014 criteria.
- ECOG performance status 0 to 2.
- Life expectancy greater than 12 weeks.
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- Adequate hematologic, hepatic, renal, coagulation, and cardiac function.
- Recovery from prior anti-cancer treatment-related toxicities to CTCAE grade 1 or baseline, except for specified stable irreversible toxicities allowed by the investigator.
- Negative pregnancy test for women of childbearing potential.
- Willingness to use effective contraception.
- Written informed consent.
Who cannot join
- Prior treatment with any EZH1/2 or EZH2 inhibitor.
- Allogeneic hematopoietic stem cell transplantation within 5 years before study treatment.
- Autologous hematopoietic stem cell transplantation within 3 months before study treatment.
- Requirement for high-dose systemic corticosteroids or other immunosuppressive therapy within 14 days before study treatment, except permitted local/inhaled or short-course use.
- Cytotoxic chemotherapy not discontinued within 14 days before study treatment.
- Systemic anti-cancer therapy or investigational therapy within 4 weeks before study treatment.
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- Major surgery within 4 weeks or radiotherapy within 90 days before study treatment.
- Active infection, including active/latent tuberculosis, HIV infection, active hepatitis B or C with detectable viral nucleic acid, or other clinically significant active viral infection.
- Uncontrolled cardiovascular disease.
- Persistent unresolved toxicities greater than CTCAE grade 1 from prior therapy, except alopecia.
- Gastrointestinal disorders or prior intestinal surgery that may impair oral drug absorption.
- Pregnancy or breastfeeding.
- Psychiatric illness or inability to provide informed consent.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for the study.
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200043
Rong Tao, MD & PhD, 008621-64175590 ext. 660103, rtao@shca.or.cn
Chuanxu Liu, MD & PhD, 008621-64175590 ext. 660103, liuchaunxu@shca.or.cn
About this study
Official title: A Multicenter, Open-Label, Seamless Phase Ib/II Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Zeprumetostat (SHR2554) in Patients With Relapsed or Refractory NK/T-Cell Lymphoma
This is a multicenter, open-label, phase Ib/II study evaluating tislelizumab in combination with zeprumetostat (SHR2554) in patients with relapsed or refractory NK/T-cell lymphoma after at least one prior asparaginase-based chemotherapy-containing regimen, with or without radiotherapy. In phase Ib, two fixed dose levels of zeprumetostat in combination with tislelizumab will be evaluated to determine the recommended phase II dose (RP2D). In phase II, patients will be enrolled into 2 predefined cohorts according to prior exposure to PD-1 inhibitors to further evaluate efficacy and safety. The primary phase II endpoint is objective response rate at week 12 assessed by independent blinded imaging review according to Lugano 2014 criteria.
Read the detailed description
This is a multicenter, open-label, phase Ib/II clinical trial in relapsed or refractory NK/T-cell lymphoma.
In phase Ib, patients with relapsed or refractory NK/T-cell lymphoma after at least 1 prior asparaginase-based chemotherapy-containing regimen will receive tislelizumab 200 mg intravenously every 3 weeks in combination with zeprumetostat at 1 of 2 dose levels: 300 mg orally twice daily or 350 mg orally twice daily. The dose-limiting toxicity observation window is 21 days. If neither dose level is excessively toxic, enrollment will continue until 12 evaluable patients are included in each arm. Dose selection for phase II will be based on dose-limiting toxicity and objective response rate at week 12 assessed by independent blinded imaging review according to Lugano 2014 criteria. If efficacy is similar, the lower dose level will be preferred.
In phase II, patients will receive zeprumetostat at the RP2D plus tislelizumab 200 mg intravenously every 3 weeks. Patients will be enrolled into 2 predefined cohorts according to prior exposure to PD-1 inhibitors: Cohort-R (prior PD-1 exposed/refractory) and Cohort-N (PD-1 inhibitor-naive). Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, loss to follow-up, death, or study termination.
The primary phase II endpoint is objective response rate at week 12 assessed by independent blinded imaging review according to Lugano 2014 criteria. Secondary endpoints include complete response rate, duration of response, progression-free survival, overall survival, and safety. Exploratory endpoints include the association of ctDNA and EBV-DNA dynamics, PD-L1, EZH2/H3K27me3, and tumor microenvironment biomarkers with clinical outcome.
- Conditions
- Extranodal NK/T-cell Lymphoma, NK/T-cell Lymphoma, Relapsed or Refractory NK/T-Cell Lymphoma
- Being tested
- Tislelizumab, Zeprumetostat
- Keywords
- Tislelizumab, Zeprumetostat, EZH2 inhibitor, PD-1 inhibitor, NKTCL
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab 200 mg administered intravenously on day 1 of each 21-day cycle.
ZeprumetostatDrug
Zeprumetostat (SHR2554), an oral EZH2 inhibitor, administered twice daily. In phase Ib, dose levels are 300 mg BID and 350 mg BID. In phase II, zeprumetostat is administered at the recommended phase II dose selected from phase Ib.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib Dose Level A | Experimental | Tislelizumab 200 mg IV every 3 weeks plus zeprumetostat 300 mg orally twice daily. Receives: Drug: Tislelizumab; Drug: Zeprumetostat |
| Phase Ib Dose Level B | Experimental | Tislelizumab 200 mg IV every 3 weeks plus zeprumetostat 350 mg orally twice daily. Receives: Drug: Tislelizumab; Drug: Zeprumetostat |
| Phase II Cohort-R (Prior PD-1 Exposed/Refractory) | Experimental | Tislelizumab 200 mg IV every 3 weeks plus zeprumetostat at the RP2D in patients previously exposed or refractory to PD-1 inhibitor therapy. Receives: Drug: Tislelizumab; Drug: Zeprumetostat |
| Phase II Cohort-N (PD-1 Inhibitor-Naive) | Experimental | Tislelizumab 200 mg IV every 3 weeks plus zeprumetostat at the RP2D in patients without prior PD-1 inhibitor therapy. Receives: Drug: Tislelizumab; Drug: Zeprumetostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase II Dose (RP2D) of zeprumetostat in combination with tislelizumab
Determination of the recommended phase II dose based on dose-limiting toxicities during the first 21 days and objective response rate at week 12.
Measured: During phase Ib, up to 12 weeks
Objective Response Rate (ORR) at Week 12
Objective response rate assessed by independent blinded imaging review according to Lugano 2014 criteria during phase II.
Measured: Week 12
Secondary outcomes (5)
Complete Response Rate (CRR)
Proportion of participants whose best overall response is complete response (CR) at week 12, as assessed according to Lugano 2014 criteria.
Measured: 12 weeks
Duration of Response (DOR)
Duration of response is defined as the time from first documented complete response (CR) or partial response (PR) to disease progression, relapse, or death, according to Lugano 2014 criteria.
Measured: From first documented CR or PR until first documented disease progression, relapse, or death, up to 36 months
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from study enrollment/first dose to the first documentation of progressive disease or death from any cause, whichever occurs first.
Measured: From first dose until first documented disease progression or death from any cause, up to 36 months
Overall Survival (OS)
Overall survival is defined as the time from study enrollment/first dose to death from any cause.
Measured: From first dose until death from any cause, up to 36 months
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-Related Adverse Events (irAEs)
Safety will be assessed by the incidence, type, severity, timing, seriousness, attribution, actions taken, and outcomes of adverse events, serious adverse events, and immune-related adverse events.
Measured: From signing of informed consent through 28 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start30 Apr 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Extranodal 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In phase Ib, participants are assigned to 1 of 2 parallel dose levels of zeprumetostat in combination with fixed-dose tislelizumab. In phase II, participants are enrolled into 2 parallel cohorts based on prior exposure to PD-1 inhibitors.
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rong Tao
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Sponsor-investigator, Rong Tao, Fudan University
- Investigators
- Rong Tao, MD & PhD, Study chair, Shanghai Cancer CenterChuanxu Liu, MD & PhD, Principal investigator, Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502768
- Sponsor's protocol ID
- SHCA-NKT-2601
- Acronym
- EpiRev-NKT
- Status last verified
- Jun 2026
- First submitted
- 20 Mar 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing is currently undecided. The study team will determine whether de-identified participant-level data can be shared after study completion in accordance with institutional policy, participant consent, and applicable regulations.
Publications
Song Y, Liu Y, Li ZM, Li L, Su H, Jin Z, Zuo X, Wu J, Zhou H, Li K, He C, Zhou J, Qi J, Hao S, Cai Z, Li Y, Wang W, Zhang X, Zou J, Zhu J. SHR2554, an EZH2 inhibitor, in relapsed or refractory mature lymphoid neoplasms: a first-in-human, dose-escalation, dose-expansion, and clinical expansion phase 1 trial. Lancet Haematol. 2022 Jul;9(7):e493-e503. doi: 10.1016/S2352-3026(22)00134-X.
PubMed 35772429Song Y, Jin Z, Li ZM, Liu Y, Li L, He C, Su H, Zhou H, Li K, Hao S, Zuo X, Wu J, Li D, Wu M, Sun X, Qi J, Cai Z, Li Z, Li Y, Huang Y, Shen J, Xiao Z, Zhu J. Enhancer of Zeste Homolog 2 Inhibitor SHR2554 in Relapsed or Refractory Peripheral T-cell Lymphoma: Data from the First-in-Human Phase I Study. Clin Cancer Res. 2024 Apr 1;30(7):1248-1255. doi: 10.1158/1078-0432.CCR-23-2582.
PubMed 38190117Huang H, Tao R, Hao S, Yang Y, Cen H, Zhou H, Guo Y, Zou L, Cao J, Huang Y, Jin J, Zhang L, Yang H, Xing X, Zhang H, Liu Y, Ding K, Qi Q, Zhu X, Zhu D, Wang S, Fang T, Dai H, Shi Q, Yang J. Sugemalimab Monotherapy for Patients With Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (GEMSTONE-201): Results From a Single-Arm, Multicenter, Phase II Study. J Clin Oncol. 2023 Jun 1;41(16):3032-3041. doi: 10.1200/JCO.22.02367. Epub 2023 Mar 30.
PubMed 36996373Tao R, Fan L, Song Y, Hu Y, Zhang W, Wang Y, Xu W, Li J. Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4). Signal Transduct Target Ther. 2021 Oct 27;6(1):365. doi: 10.1038/s41392-021-00768-0.
PubMed 34702811
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Seamless Phase Ib/II Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Zeprumetostat (SHR2554) in Patients With Relapsed or Refractory NK/T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07502768
- Acronym / sponsor ID
- EpiRev-NKT / SHCA-NKT-2601
- Conditions
- Extranodal NK/T-cell Lymphoma, NK/T-cell Lymphoma, Relapsed or Refractory NK/T-Cell Lymphoma
- Keywords
- Tislelizumab, Zeprumetostat, EZH2 inhibitor, PD-1 inhibitor, NKTCL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Rong TaoUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 31 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.
This is a multicenter, open-label, phase Ib/II study evaluating tislelizumab in combination with zeprumetostat (SHR2554) in patients with relapsed or refractory NK/T-cell lymphoma after at least one prior asparaginase-based chemotherapy-containing regimen, with or without radiotherapy. In phase Ib, two fixed dose levels of zeprumetostat in combination with tislelizumab will be evaluated to determine the recommended phase II dose (RP2D). In phase II, patients will be enrolled into 2 predefined cohorts according to prior exposure to PD-1 inhibitors to further evaluate efficacy and safety. The primary phase II endpoint is objective response rate at week 12 assessed by independent blinded imaging review according to Lugano 2014 criteria.
Detailed description
This is a multicenter, open-label, phase Ib/II clinical trial in relapsed or refractory NK/T-cell lymphoma.
In phase Ib, patients with relapsed or refractory NK/T-cell lymphoma after at least 1 prior asparaginase-based chemotherapy-containing regimen will receive tislelizumab 200 mg intravenously every 3 weeks in combination with zeprumetostat at 1 of 2 dose levels: 300 mg orally twice daily or 350 mg orally twice daily. The dose-limiting toxicity observation window is 21 days. If neither dose level is excessively toxic, enrollment will continue until 12 evaluable patients are included in each arm. Dose selection for phase II will be based on dose-limiting toxicity and objective response rate at week 12 assessed by independent blinded imaging review according to Lugano 2014 criteria. If efficacy is similar, the lower dose level will be preferred.
In phase II, patients will receive zeprumetostat at the RP2D plus tislelizumab 200 mg intravenously every 3 weeks. Patients will be enrolled into 2 predefined cohorts according to prior exposure to PD-1 inhibitors: Cohort-R (prior PD-1 exposed/refractory) and Cohort-N (PD-1 inhibitor-naive). Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, loss to follow-up, death, or study termination.
The primary phase II endpoint is objective response rate at week 12 assessed by independent blinded imaging review according to Lugano 2014 criteria. Secondary endpoints include complete response rate, duration of response, progression-free survival, overall survival, and safety. Exploratory endpoints include the association of ctDNA and EBV-DNA dynamics, PD-L1, EZH2/H3K27me3, and tumor microenvironment biomarkers with clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- In phase Ib, participants are assigned to 1 of 2 parallel dose levels of zeprumetostat in combination with fixed-dose tislelizumab. In phase II, participants are enrolled into 2 parallel cohorts based on prior exposure to PD-1 inhibitors.
| Arm | Type | Receives |
|---|---|---|
| Phase Ib Dose Level A | Experimental | Drug: Tislelizumab, Drug: ZeprumetostatTislelizumab 200 mg IV every 3 weeks plus zeprumetostat 300 mg orally twice daily. |
| Phase Ib Dose Level B | Experimental | Drug: Tislelizumab, Drug: ZeprumetostatTislelizumab 200 mg IV every 3 weeks plus zeprumetostat 350 mg orally twice daily. |
| Phase II Cohort-R (Prior PD-1 Exposed/Refractory) | Experimental | Drug: Tislelizumab, Drug: ZeprumetostatTislelizumab 200 mg IV every 3 weeks plus zeprumetostat at the RP2D in patients previously exposed or refractory to PD-1 inhibitor therapy. |
| Phase II Cohort-N (PD-1 Inhibitor-Naive) | Experimental | Drug: Tislelizumab, Drug: ZeprumetostatTislelizumab 200 mg IV every 3 weeks plus zeprumetostat at the RP2D in patients without prior PD-1 inhibitor therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years or older.
- Pathologically confirmed NK/T-cell lymphoma.
- Relapsed or refractory disease after at least 1 prior asparaginase-based chemotherapy-containing regimen, with or without radiotherapy.
- At least 1 measurable or evaluable lesion according to Lugano 2014 criteria.
- ECOG performance status 0 to 2.
Key exclusion criteria (14 listed)
- Prior treatment with any EZH1/2 or EZH2 inhibitor.
- Allogeneic hematopoietic stem cell transplantation within 5 years before study treatment.
- Autologous hematopoietic stem cell transplantation within 3 months before study treatment.
- Requirement for high-dose systemic corticosteroids or other immunosuppressive therapy within 14 days before study treatment, except permitted local/inhaled or short-course use.
- Cytotoxic chemotherapy not discontinued within 14 days before study treatment.
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 |
|---|---|---|
| TislelizumabTislelizumab 200 mg administered intravenously on day 1 of each 21-day cycle. | Drug | Phase II Cohort-N (PD-1 Inhibitor-Naive), Phase II Cohort-R (Prior PD-1 Exposed/Refractory), Phase Ib Dose Level A, Phase Ib Dose Level B |
| ZeprumetostatZeprumetostat (SHR2554), an oral EZH2 inhibitor, administered twice daily. In phase Ib, dose levels are 300 mg BID and 350 mg BID. In phase II, zeprumetostat is administered at the recommended phase II dose selected from phase Ib. | Drug | Phase II Cohort-N (PD-1 Inhibitor-Naive), Phase II Cohort-R (Prior PD-1 Exposed/Refractory), Phase Ib Dose Level A, Phase Ib Dose Level B |
Primary outcome
Recommended Phase II Dose (RP2D) of zeprumetostat in combination with tislelizumab
Time frame: During phase Ib, up to 12 weeks
Determination of the recommended phase II dose based on dose-limiting toxicities during the first 21 days and objective response rate at week 12.
Objective Response Rate (ORR) at Week 12
Time frame: Week 12
Objective response rate assessed by independent blinded imaging review according to Lugano 2014 criteria during phase II.
5 secondary outcomes
Complete Response Rate (CRR)
Time frame: 12 weeks
Duration of Response (DOR)
Time frame: From first documented CR or PR until first documented disease progression, relapse, or death, up to 36 months
Progression-Free Survival (PFS)
Time frame: From first dose until first documented disease progression or death from any cause, up to 36 months
Overall Survival (OS)
Time frame: From first dose until death from any cause, up to 36 months
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-Related Adverse Events (irAEs)
Time frame: From signing of informed consent through 28 days after the last dose of study treatment
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 18 Jun 2026.
- Results publication: PubMed 35772429Song Y, Liu Y, Li ZM, Li L, Su H, Jin Z, Zuo X, Wu J, Zhou H, Li K, He C, Zhou J, Qi J, Hao S, Cai Z, Li Y, Wang W, Zhang X, Zou J, Zhu J. SHR2554, an EZH2 inhibitor, in relapsed or refractory mature lymphoid neoplasms: a first-in-human, dose-escalation, dose-expansion, and clinical expansion phase 1 trial. Lancet Haematol. 2022 Jul;9(7):e493-e503. doi: 10.1016/S2352-3026(22)00134-X.
- Results publication: PubMed 38190117Song Y, Jin Z, Li ZM, Liu Y, Li L, He C, Su H, Zhou H, Li K, Hao S, Zuo X, Wu J, Li D, Wu M, Sun X, Qi J, Cai Z, Li Z, Li Y, Huang Y, Shen J, Xiao Z, Zhu J. Enhancer of Zeste Homolog 2 Inhibitor SHR2554 in Relapsed or Refractory Peripheral T-cell Lymphoma: Data from the First-in-Human Phase I Study. Clin Cancer Res. 2024 Apr 1;30(7):1248-1255. doi: 10.1158/1078-0432.CCR-23-2582.
- Results publication: PubMed 36996373Huang H, Tao R, Hao S, Yang Y, Cen H, Zhou H, Guo Y, Zou L, Cao J, Huang Y, Jin J, Zhang L, Yang H, Xing X, Zhang H, Liu Y, Ding K, Qi Q, Zhu X, Zhu D, Wang S, Fang T, Dai H, Shi Q, Yang J. Sugemalimab Monotherapy for Patients With Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (GEMSTONE-201): Results From a Single-Arm, Multicenter, Phase II Study. J Clin Oncol. 2023 Jun 1;41(16):3032-3041. doi: 10.1200/JCO.22.02367. Epub 2023 Mar 30.
- Results publication: PubMed 34702811Tao R, Fan L, Song Y, Hu Y, Zhang W, Wang Y, Xu W, Li J. Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4). Signal Transduct Target Ther. 2021 Oct 27;6(1):365. doi: 10.1038/s41392-021-00768-0.
- Individual participant dataSharing planned: Undecided. IPD sharing is currently undecided. The study team will determine whether de-identified participant-level data can be shared after study completion in accordance with institutional policy, participant consent, and applicable regulations.
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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.
Rong Tao, MD & PhD study chair
Shanghai Cancer Center
Chuanxu Liu, MD & PhD principal investigator
Shanghai Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tislelizumab and Zeprumetostat in people with Extranodal NK/T-cell Lymphoma and NK/T-cell Lymphoma, run by Rong Tao 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 11 inclusion and 14 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 18 Jun 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Rong Tao, MD & PhD (008621-64175590 ext. 660103, hkutao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase II Dose (RP2D) of zeprumetostat in combination with tislelizumab (time frame: During phase Ib, up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07502768, which also lists 4 linked publications.
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 18 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.