Tislelizumab Plus Zeprumetostat for 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.

NCT Number	NCT07502768
Lead Sponsor	Rong Tao Collaborators: Fudan University
Conditions	Extranodal NK/T-cell Lymphoma, NK/T-cell Lymphoma, Relapsed or Refractory NK/T-Cell Lymphoma
Enrollment	107 participants
Start Date	2026-04-30
Primary Completion	2027-12-30 (estimated)
Study Completion	2028-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-18