Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma

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. 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

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.

Conditions2

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