Tislelizumab Plus Zeprumetostat for Relapsed or Refractory NK/T-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRong Tao
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Tislelizumab
- Zeprumetostat
Treatment groups
107 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov