Status:
RECRUITING
Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma
Lead Sponsor:
Fudan University
Conditions:
Relapsed/Refractory Peripheral T Cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is an open-label, prospective and exploratory clinical study to evaluate the efficacy and safety of JAK inhibitor SHR-0302 in combination with EZH2 inhibitor SHR-2554 in patients with R/R PTCL. T...
Detailed Description
This is an open-label, prospective, exploratory clinical study. The plan is to enroll 12-25 patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL) to receive a combination of SHR-0302...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06519526
Start Date
August 12 2024
End Date
August 31 2027
Last Update
August 21 2024
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032