This is a randomized, double-blind, multi-center, phase III clinical trial designed to evaluate the efficacy of XNW5004 tablets versus Chidamide in Relapsed/Refractory PTCL, with a target of enrolling 120 subjects.
Aged 18-70 years (inclusive)，gender not limited.
Pathologically diagnosed, relapsed or refractory peripheral T-cell lymphoma.
Disease status defined as relapsed or refractory after >=1 prior systemic treatment lines, and have not received treatment with HDAC inhibitors, subjects with NK/T-cell lymphoma require treatment with a regimen containing asparaginase/protease, subjects with CD30 positive ALCL require prior treatment with Brentuximab vedotin.
Subjects who have received prior radiotherapy are allowed to enroll, but radiotherapy alone is not considered a systemic therapy.
Prior exposure to EZH2 inhibitor(s) or EZH1/2 inhibitor(s).
Prior exposure to HDAC inhibitor(s).
Subjects with known hypersensitivity to the study drug or its active ingredients or excipients.
Subjects who have received anti-tumor therapy, such as chemotherapy, immunotherapy, radiotherapy, and targeted therapy, within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, received CAR-T therapy within 12 weeks prior to the first dose of the study drug, autologous hematopoietic stem cell transplantation (Auto-HSCT) within 3 months prior to the first dose of the study drug.
Parallel
XNW5004 ; Chidamide placebo
DrugXNW5004 + Chidamide placebo
XNW5004 placebo; Chidamide
DrugXNW5004 placebo + Chidamide
Progression Free Survival (PFS) assessed by BICR
Objective response rate (ORR)
Time to Response
Duration of response
Overall survival
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