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

Phase 1

Recruiting

• Conditions: Peripheral T-cell Lymphoma
• Interventions: Drug: SHR2554/CHOP; Drug: SHR2554/CHOEP

• Registration Number: NCT06173999
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-08
• Study First Posted: 2023-12-18
• Study Start: 2023-12-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-11
• Last Update Posted: 2024-05-14
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group A	SHR2554/CHOP	-
Treatment group B	SHR2554/CHOEP	-

Primary Outcome Measures

Name	Time	Method
Safety endpoints: incidence and severity of adverse events (AEs)	through study completion, an average of about 6 months	Ib phase
Overall response rate (ORR)	90 days since the date of first dose	II phase

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs)	through study completion, an average of about 6 months	II phase
Plasma concentration	Day 1 of cycle 1 to day 1 of cycle 4 (21 days/cycle)	Ib phase
Progression Free Survival (PFS)	through study completion, an average of about 6 months	II phase
Overall Survival (OS)	2 years since the date of first dose	II phase
Duration of response (DOR)	through study completion, an average of about 6 months	II phase

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China