Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma
- Conditions
- Relapsed/Refractory Peripheral T Cell Lymphoma
- Registration Number
- NCT06519526
- Lead Sponsor
- Fudan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria:<br><br> - Males or females aged 18-70 years (inclusive);<br><br> - Histologically confirmed peripheral T-cell lymphoma;<br><br> - Disease status defined as relapsed or refractory after >=1 prior systemic treatment<br> lines;<br><br> - Have measurable lesions;<br><br> - ECOG performance status must be 0 or 1 and has not deteriorated in the past 2 weeks;<br><br> - Life expectancy =12 weeks;<br><br> - Adequate bone marrow reserve and organ system function reserve;<br><br> - Participants should be able and willing to comply with the study protocol<br> requirement;<br><br>Exclusion Criteria:<br><br> - Received anti-tumor treatment within 28 days prior to the first dose of the study<br> drug; received Chinese medicine treatment with anti-tumor effect within 14 days<br> before the first dose of the study drug; received steroid hormones within 7 days<br> prior to the first dose of study drug administration;<br><br> - Underwent major surgery within 4 weeks prior to the first dose of study treatment;<br><br> - Severe cardiovascular disease;<br><br> - Cerebrovascular accident or transient ischemic attack within 6 months prior to<br> enrollment;<br><br> - Significant impairment of lung function;<br><br> - Active infections;<br><br> - Unexplained fever > 38.5°C during screening period or on the first day of<br> medication;<br><br> - Pregnant;<br><br> - Known alcohol or drug abuse;<br><br> - Subjects are currently receiving known moderately potent or potent CYP<br> inducers/inhibitors or P-glycoprotein (P-gp) inhibitors;<br><br> - History of hypersensitivity to the investigational drug or its excipients;<br><br> - In the judgment of the investigator, objective conditions make the subject unable to<br> complete the planned study or the subject has other factors, concomitant diseases,<br> combined treatment or abnormal laboratory examination that may lead to the forced<br> termination of the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and severity of AEs and SAEs;Objective response rate (ORR)
- Secondary Outcome Measures
Name Time Method Disease Control Rate (DCR);Duration of Response (DoR);Progression-free Survival (PFS);Overall Survival (OS)