Tislelizumab Plus Zeprumetostat for Relapsed or Refractory NK/T-Cell Lymphoma (NCT07502768) | Clinical Trial Compass
RecruitingPhase 1/2
Tislelizumab Plus Zeprumetostat for Relapsed or Refractory NK/T-Cell Lymphoma
China107 participantsStarted 2026-04-30
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* 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.
Exclusion Criteria:
* 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.
* Major surgery within 4 weeks or radiotherapy within 90 days before study treatment.
* Active infection, includ…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is still in Phase 1/2, meaning it's partly focused on figuring out the right dose of zeprumetostat combined with tislelizumab, what does that mean for how much is known about the safety of this combination in people with NK/T-cell lymphoma like mine?
2The trial is measuring objective response rate at 12 weeks as a key outcome — based on what's been seen so far, or what's known about these two drugs separately, is there any early signal about how likely a response might be for someone at my stage of relapsed or refractory disease?
3Zeprumetostat is an EZH2 inhibitor and tislelizumab is a PD-1 checkpoint inhibitor — what are the most important side effects I should watch for when these two types of drugs are combined, and how are those side effects typically managed?
4Before considering this trial, are there standard salvage treatment options for relapsed or refractory NK/T-cell lymphoma that I should try first, or would enrolling in this study be a reasonable path to discuss given where I am in my treatment history?
5What would my visit schedule and overall commitment look like if I were to participate in this trial, and are there any requirements — like how recently I received prior treatment — that my doctor would need to review to see if this could even be a fit for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recommended Phase II Dose (RP2D) of zeprumetostat in combination with tislelizumab