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Tislelizumab Plus Zeprumetostat for Relapsed or Refractory NK/T-Cell Lymphoma

Study acronym: EpiRev-NKT
StatusRecruiting
PhasePhase 1/2
SponsorRong Tao
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened
    • Start date changed from estimate of Mar 23, 2026 to Apr 30, 2026
    • Site details revised
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07502768
Lead Sponsor Rong Tao
Collaborators: Fudan University
Conditions
(from sponsor)
Extranodal NK/T-cell Lymphoma, NK/T-cell Lymphoma, Relapsed or Refractory NK/T-Cell Lymphoma
Related terms Lymphoma, Extranodal NK-T-Cell, Recurrence
Enrollment 107 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov