This is a single-arm, multi-cohort, multicenter, phase Ib/IIa clinical study designed to evaluate the safety and efficacy of Zeprumetostat (an EZH2 inhibitor) in combination with different therapeutic agents/regimens - specifically, the JAK1 inhibitor golidocitinib and the GemOx chemotherapy regimen (gemcitabine plus oxaliplatin) - in patients with relapsed or refractory peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) and T-follicular helper cell lymphoma (TFHL). The trial comprises a phase Ib dose-escalation phase and a phase IIa dose-expansion phase. Two combination cohorts are established: Cohort A (zemitostatin + golidocitinib) and Cohort B (zemitostatin + GemOx). Subjects will be randomly assigned to either Cohort A or Cohort B.
Age 18 years or older, both males and females are eligible;
Patients who have undergone prior hematopoietic stem cell transplantation are allowed;
ECOG PS 0-2
Life expectancy greater than 3 months.
Prior treatment with EZH2 inhibitors or EZH1/2 inhibitors before enrollment;
Peripheral T-cell lymphoma of subtypes other than PTCL-NOS and TFHL;
History of other primary invasive malignancies that have not been in remission or have been in remission for no more than 3 years;
Central nervous system involvement (meningeal or parenchymal);
Single group
Zeprumetostat( an EZH2 inhibitor) + X
DrugZeprumetostat( an EZH2 inhibitor) + JAK1 inhibitor or GemOx
Summary of DLT events (Phase Ib)
A Phase Ib Dose-Finding Study of Zeprumetostat in Combination Using a 3+3 Design
Overall response rate (Phase Ⅱ)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment EZH2+JAK1/GeMox
Complete response rate
Complete Response Rate (CRR) is defined as the proportion of subjects who achieve CR after treatment EZH2+JAK1/GeMox
Duration of response
Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or PR) to the first documented relapse evidence of the responders.
Progression free survival
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first
Overall survival
Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first
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