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

NCT06519526 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-03-24

No results posted yet for this study

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.

Conditions

  • Relapsed/Refractory Peripheral T Cell Lymphoma

Interventions

DRUG

SHR-0302

SHR-0302 will be administered orally as tablets.

DRUG

SHR-2554

SHR-2554 will be administered orally as tablets.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Rong Tao, MD · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06519526 on ClinicalTrials.gov