drugset / Trial / NCT06519526

Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma

NCT06519526

Phase 2 Recruiting 25 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-08-12
Primary completion
2027-02-28
Completion
2027-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject SHR0302 Unknown Oral
Subject SHR2554 Small molecule Oral