SHR2554 as Maintenance Therapy in Patients With Peripheral T-cell Lymphoma

An Open-label, Multicenter Exploratory Clinical Study of the EZH2 Inhibitor SHR2554 as Maintenance Therapy After First-line Systemic Treatment in Patients With Peripheral T-cell Lymphoma

Evaluation of the Safety and Efficacy of SHR2554 as Maintenance Therapy after first-line systemic treatment in patients with peripheral T-cell lymphoma

Study Overview

• Status: Not yet recruiting
• Conditions: PTCL
• Intervention / Treatment: Drug: SHR2554 Tablets

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wei Xu, Doctor; Phone Number: 86-2568302182; Email: xuwei10000@hotmail.com
• Study Contact Backup: Name: Jinhua Liang, M.D; Phone Number: 86-2568302182; Email: 1151525490@qq.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • The First Affiliated Hospital with Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years old
2. Histologically confirmed PTCL,including PTCL NOS, ALCL, nTFHL,MEITL,ENKTL etc. according to WHO 2022 criteria.
3. Previously received first-line systemic induction therapy and achieved CR/PR; Auto-transplantation or allo-transplantation are allowed.
4. A measurable or evaluable disease at the time of first diagnosis of PTCL (any nodes/nodal masses>1.5 cm in longest diameter (LDi) or extralymphatic sites of disease >1.0 cm in LDi)
5. ECOG PS 0-2
6. With adequate organ function
7. Expected survival ≥ 12 weeks
8. Women of childbearing potential (WOCBP) should be proven to be negative by human chorionic gonadotropin (hCG) test in 7 days before the first dose of SHR2554. They must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy from the day they sign the informed consent form (ICF) to at least 30 days after receiving the last dose of study treatment. Male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy；
9. Participant who has provided written consent to participate in the study and ability to comply with all aspects of the protocol.

Exclusion Criteria:

1. cutaneous T cell lymphoma
2. Has a prior malignancy other than the malignancies under study within 3 years without relieve
3. Participants with a presence of central nerves invasion
4. Known sensitivity or allergy to investigational product
5. Participated in another clinical trial within 4 weeks prior to the start of the study;
6. Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
7. Active infected persons, except tumor-related B symptom fever;
8. Diseases and medical history:

1.have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 2.have a history of psychotropic substance abuse and can not quit or have mental disorders; 3.Subjects with any severe and/or uncontrolled medical condition; 9.A history of immunodeficiency 10.Patients with mental disorders or those unable to provide informed consent 11.In any conditions which investigator considered ineligible for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR2554 monotherapy; Patients With Peripheral T-cell Lymphoma After First-line Systemic Treatment Receiving SHR2554 monotherapy as Maintenance Therapy	Drug: SHR2554 Tablets; SHR2554 orally twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2 years PFS	The 2-year rate of during and after treatment that the participant lives without progression of the disease, as assessed by 2014 Lugano criteria.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year and 2-year DFS rates for patients who were in CR at enrollment	The rate of 1-year and 2-year that the participant lives without disease, as assessed by 2014 Lugano criteria.	1year,2year
Rate of patients who were PR at enrollment converting to CR	The Rate of patients who were PR at enrollment converting to CR	Time from the first dose to any events, assessed up to 12 months
Complete Response Rate (CR)	The proportion of participants who achieve a complete response (CR) during the treatment period, as assessed by the 2014 Lugano criteria using FDG-PET imaging.	Time from the first dose to disease progression or death, assessed up to 12months
Duration of Response (DoR)	The interval from the initial documentation of response (CR or PR) to the first documentation of disease progression or death.	From the date response is first documented to the date of disease progression or death, up to 36 months
Progression-Free Survival (PFS)	The length of time during and after treatment that the participant lives without progression of the disease, as assessed by 2014 Lugano criteria.	Time from the first dose to disease progression or death, assessed up to 36 months
Overall Survival (OS)	The length of time from the start of treatment until death from any cause.	Time from the first dose to death from any cause, assessed up to 36 months
Incidence of Treatment-Related Adverse Events (Safety and Tolerability)	The incidence, type, and severity of adverse events (graded according to CTCAE v5.0), and their relationship to the study treatment.	Up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal Residual Disease (MRD)-Negative Rate	The proportion of patients who achieve minimal residual disease negativity at the completion of treatment.	Up to 12 months after the first dose

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-SR-1121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No