NCT07502768 Tislelizumab Plus Zeprumetostat for Relapsed or Refractory NK/T-Cell Lymphoma
| NCT ID | NCT07502768 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Rong Tao |
| Condition | Extranodal NK/T-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 107 participants |
| Start Date | 2026-04-30 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 107 participants in total. It began in 2026-04-30 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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, 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.
Contact & Investigator
Rong Tao, MD & PhD
STUDY CHAIR
Shanghai Cancer Center
Frequently Asked Questions
Who can join the NCT07502768 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Extranodal NK/T-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07502768 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07502768 currently recruiting?
Yes, NCT07502768 is actively recruiting participants. Contact the research team at hkutao@hotmail.com for enrollment information.
Where is the NCT07502768 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07502768 clinical trial?
NCT07502768 is sponsored by Rong Tao. The principal investigator is Rong Tao, MD & PhD at Shanghai Cancer Center. The trial plans to enroll 107 participants.