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

NCT07502768 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

  • Extranodal NK/T-cell Lymphoma
  • NK/T-cell Lymphoma
  • Relapsed or Refractory NK/T-Cell Lymphoma

Interventions

DRUG

Tislelizumab

Tislelizumab 200 mg administered intravenously on day 1 of each 21-day cycle.

DRUG

Zeprumetostat

Zeprumetostat (SHR2554), an oral EZH2 inhibitor, administered twice daily. In phase Ib, dose levels are 300 mg BID and 350 mg BID. In phase II, zeprumetostat is administered at the recommended phase II dose selected from phase Ib.

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Rong Tao

    lead OTHER

Principal Investigators

  • Rong Tao, MD & PhD · Shanghai Cancer Center

  • Chuanxu Liu, MD & PhD · Shanghai Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-23
Primary Completion
2027-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07502768 on ClinicalTrials.gov