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

NCT07347288 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-SR-1121
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PTCL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 1-year and 2-year DFS rates for patients who were in CR at enrollment

  1year,2year

• 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)

  Time from the first dose to disease progression or death, assessed up to 12months

• Duration of Response (DoR)

  From the date response is first documented to the date of disease progression or death, up to 36 months

• Progression-Free Survival (PFS)

  Time from the first dose to disease progression or death, assessed up to 36 months

Other Outcomes (1)

• Minimal Residual Disease (MRD)-Negative Rate

  Up to 12 months after the first dose

Study Arms (1)

SHR2554 monotherapy

EXPERIMENTAL

Patients With Peripheral T-cell Lymphoma After First-line Systemic Treatment Receiving SHR2554 monotherapy as Maintenance Therapy

Drug: SHR2554 Tablets

Interventions

SHR2554 Tablets DRUG

SHR2554 orally twice daily

SHR2554 monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old
• Histologically confirmed PTCL,including PTCL NOS, ALCL, nTFHL,MEITL,ENKTL etc. according to WHO 2022 criteria.
• Previously received first-line systemic induction therapy and achieved CR/PR; Auto-transplantation or allo-transplantation are allowed.
• 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)
• ECOG PS 0-2
• With adequate organ function
• Expected survival ≥ 12 weeks
• 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；
• Participant who has provided written consent to participate in the study and ability to comply with all aspects of the protocol.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Central Study Contacts

Wei Xu, Doctor

CONTACT

86-2568302182; xuwei10000@hotmail.com

Jinhua Liang, M.D

CONTACT

86-2568302182; 1151525490@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)