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

Nanjing Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: PTCL

Treatments: Drug: SHR2554 Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT07347288

2025-SR-1121

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

SHR2554 monotherapy

Experimental group

Description:

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

Treatment:

Drug: SHR2554 Tablets