Recruiting

A Phase Ib/II, Open-label, Multi-center Study of SHR2554 With CHOP/CHOEP in Treatment-naïve Patients With Peripheral T-cell Lymphoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

SHR2554/CHOP

+ SHR2554/CHOEP

Drug
Who is being recruted

Hemic and Lymphatic Diseases+8

+ Immune System Diseases

+ Immunoproliferative Disorders

From 18 to 70 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: December 2023
See protocol details

Summary

Principal SponsorJiangsu HengRui Medicine Co., Ltd.
Study ContactYang Wu
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 22, 2023

Actual date on which the first participant was enrolled.

This clinical trial is focused on finding out how safe and effective a new drug, SHR2554, is when used together with standard chemotherapy treatments, CHOP or CHOEP, in patients who have never received treatment for peripheral T-cell lymphoma. Peripheral T-cell lymphoma is a type of blood cancer that affects the lymphatic system, and exploring new treatment options is crucial for improving outcomes for those affected by this condition. This study aims to provide a new potential treatment combination that might work better or have fewer side effects than current options. Participants in this study will receive SHR2554 in combination with the chemotherapy drugs CHOP or CHOEP. The study will monitor how well this combination works and check for any side effects that participants experience. By closely observing the effects of the treatment, researchers hope to gather valuable information about its safety and how effectively it can combat the cancer. The goal is to ensure that the treatment is not only effective but also safe for patients.

Official TitleA Phase Ib/II, Open-label, Multi-center Study of SHR2554 With CHOP/CHOEP in Treatment-naïve Patients With Peripheral T-cell Lymphoma
NCT06173999
Principal SponsorJiangsu HengRui Medicine Co., Ltd.
Study ContactYang Wu
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, T-CellLymphoma, T-Cell, Peripheral

Criteria

6 inclusion criteria required to participate
Males or females aged 18-70 years (inclusive);
Have measurable lesions ;
Histologically confirmed peripheral T-cell lymphoma;
Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1;
Show More Criteria
6 exclusion criteria prevent from participating
Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug;
Known active HBV or HCV infection;
History of clinically significant cardiovascular disease;
History of other malignancies within 5 years;
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Beijing Cancer Hospital

Beijing, ChinaOpen Beijing Cancer Hospital in Google Maps
Recruiting
One Study Center