A Study of SHR2554 With Chemotherapy in Treatment-naïve Patients With Peripheral T-cell Lymphoma

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The study is being conducted to evaluate the safety and efficacy of SHR2554 with CHOP/CHOEP in treatment- naïve peripheral T-cell lymphoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

1. Males or females aged 18-70 years (inclusive);

2. Histologically confirmed peripheral T-cell lymphoma;

3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1;

4. Life expectancy ≥ 12 weeks;

5. Have measurable lesions ;

6. The subject is willing and able to comply with the visit schedule, dosing schedule, laboratory tests, and other clinical study procedures.

Exclusion Criteria:

1. Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug;

2. Known active HBV or HCV infection;

3. History of clinically significant cardiovascular disease;

4. History of other malignancies within 5 years;

5. Pregnant or lactating women;

6. Based on the investigator's judgment, there are objective conditions that may prevent the subject from completing the study as planned or the subject has other factors, concomitant diseases, concomitant treatments, or abnormal laboratory findings that may lead to early study termination.