This is a prospective, multicenter, open-label, phase Ib/II clinical study to evaluate the safety and efficacy of EZH2 inhibitor Zeprumetostat in combination therapy for patients with relapsed or refractory mature T-cell and NK-cell lymphomas.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
350mg, po, bid
Cohort 1: Golidocitinib: 150mg, po, qd
Cohort 2: Chidamide: 20mg, po, biw
DLT for Phase 1b
To identify the dose-limiting toxicity
Time frame: The first cycle after administration (each cycle is 28 days)
Overall response rate(ORR) for Phase 2
The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.
Time frame: Up to 24 months
RP2D for phase Ib
To identify the recommended phase 2 dose
Time frame: The first cycle after administration (each cycle is 28 days)
Complete response rate (CRR)
Defined as the proportion of patients who achieve complete remission as the best response
Time frame: Up to 24 months
Duration of Response(DOR)
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 4 years
Progression-free survival(PFS)
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 4 years
Overall survival(OS)
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 4 years
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