Tislelizumab plus Zeprumetostat in relapsed or refractory NK/T-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label phase Ib/II trial evaluating tislelizumab with zeprumetostat in adults with relapsed or refractory NK/T-cell lymphoma after at least one prior asparaginase-based regimen. Phase Ib determines the RP2D using two zeprumetostat dose levels, with toxicity and week-12 responses guiding dose selection. Phase II enrolls patients into two cohorts based on prior PD-1 inhibitor exposure to further assess efficacy and safety, with objective response rate at week 12 as the primary endpoint. Secondary endpoints include complete response rate and safety measures. Treatment continues until progression, toxicity, or withdrawal, with imaging reviewed by independent blinded review per Lugano 2014 criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Chuanxu Liu, MD & PhD — Shanghai Cancer Center
• Study coordinator: Rong Tao, MD & PhD
• Email: hkutao@hotmail.com
• Phone: 008621-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.