NCT06519526

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Relapsed/Refractory Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	SHR-0302	SHR-0302 will be administered orally as tablets.
DRUG	SHR-2554	SHR-2554 will be administered orally as tablets.

Timeline

• Start date: 2024-08-12
• Primary completion: 2027-02-28
• Completion: 2027-08-31
• First posted: 2024-07-25
• Last updated: 2026-03-24

Locations

1 site across 1 country: China