Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma
Sponsored by Fudan University
About this trial
Last updated 10 months ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started a year ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Males or females aged 18-70 years (inclusive);
- Histologically confirmed peripheral T-cell lymphoma;
- Disease status defined as relapsed or refractory after >=1 prior systemic treatment lines;
- Have measurable lesions;
- ECOG performance status must be 0 or 1 and has not deteriorated in the past 2 weeks;
- Life expectancy ≥12 weeks;
- Adequate bone marrow reserve and organ system function reserve;
- Participants should be able and willing to comply with the study protocol requirement;
Exclusion Criteria
- Received anti-tumor treatment within 28 days prior to the first dose of the study drug; received Chinese medicine treatment with anti-tumor effect within 14 days before the first dose of the study drug; received steroid hormones within 7 days prior to the first dose of study drug administration;
- Underwent major surgery within 4 weeks prior to the first dose of study treatment;
- Severe cardiovascular disease;
- Cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment;
- Significant impairment of lung function;
- Active infections;
- Unexplained fever > 38.5°C during screening period or on the first day of medication;
- Pregnant;
- Known alcohol or drug abuse;
- Subjects are currently receiving known moderately potent or potent CYP inducers/inhibitors or P-glycoprotein (P-gp) inhibitors;
- History of hypersensitivity to the investigational drug or its excipients;
- In the judgment of the investigator, objective conditions make the subject unable to complete the planned study or the subject has other factors, concomitant diseases, combined treatment or abnormal laboratory examination that may lead to the forced termination of the study.