Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFudan University
About this trial
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. The study plans to enroll approximately 25 patients. 6-12 patients will receive SHR-0302 monotherapy and SHR-0302+SHR-2554 combination therapy in the safety run-in phase. According to the safety observed, the investigators discuss and decide to select a dose group to explore the efficacy and safety. 13 patients may be enrolled in the expansion phase.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- SHR-0302
- SHR-2554
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov