Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma
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.
• Males or females aged 18-70 years (inclusive);
• Histologically confirmed peripheral T-cell lymphoma;
• Disease status defined as relapsed or refractory after \>=1 prior systemic treatment lines;
• Have measurable lesions;
• ECOG performance status must be 0 or 1 and has not deteriorated in the past 2 weeks;
• Life expectancy ≥12 weeks;
• Adequate bone marrow reserve and organ system function reserve;
• Participants should be able and willing to comply with the study protocol requirement;