This is an open-label, prospective and exploratory clinical study to evaluate the efficacy and safety of JAK inhibitor SHR-0302 in combination with EZH2 inhibitor SHR-2554 in patients with R/R PTCL. The study plans to enroll approximately 25 patients. 6-12 patients will receive SHR-0302 monotherapy and SHR-0302+SHR-2554 combination therapy in the safety run-in phase. According to the safety observed, the investigators discuss and decide to select a dose group to explore the efficacy and safety. 13 patients may be enrolled in the expansion phase.
This is an open-label, prospective, exploratory clinical study. The plan is to enroll 12-25 patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL) to receive a combination of SHR-0302 and SHR-2554. The primary objectives are to evaluate the efficacy and safety of the SHR-0302 and SHR-2554 combination in the treatment of r/r PTCL. Subjects will receive the investigating drugs combination (SHR-0302 and SHR-2554) until study completion, unacceptable toxicity, disease progression, withdrawal of informed consent, or investigators discontinue treatment. The study is divided into two parts. Part I is a safety run-in phase, and part II is an efficacy exploration phase. Part I: Cohort 1: Explore the recommended dose and safety of SHR-0302 monotherapy Cohort 2: Based on the efficacy and safety observed in Cohort 1, explore the clinically recommended dose and safety of the SHR-0302 and SHR-2554. Part II: Based on the safety and tolerability observed during part I, the investigators will discuss and select one tolerable dose cohort to explore the efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGIncidence and severity of AEs and SAEs
Incidence and severity of AEs and SAEs will be recorded and graded according to the CTCAE 5.0.
Time frame: The first dose until 30 days after last dose
Objective response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR) according to Lugano 2014 criteria.
Time frame: 24 months
Disease Control Rate (DCR)
Percentage of patients achieving complete response (CR) and partial response (PR) and stable disease (SD) according to Lugano 2014 criteria.
Time frame: 24 months
Duration of Response (DoR)
Defined as the time from the date of the first CR or PR to the date of the first PD or death due to any cause, whichever occurs first.
Time frame: 24 months
Progression-free Survival (PFS)
Defined as the time from the date of the first dose to the first documented PD or death due to any cause, whichever occurs first.
Time frame: 24 months
Overall Survival (OS)
Defined as the duration of time from start of treatment to death from any cause.
Time frame: 24 months
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