Evaluating SHR-0302 and SHR-2554 for treating relapsed peripheral T-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This exploratory clinical study aims to assess the safety and efficacy of the JAK inhibitor SHR-0302 in combination with the EZH2 inhibitor SHR-2554 in patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL). The study will enroll approximately 25 patients, starting with a safety run-in phase where 6-12 patients will receive either SHR-0302 alone or the combination therapy. Based on the safety data, a dose will be selected for further exploration of efficacy in an expansion phase. Participants will be monitored until study completion or until they experience unacceptable toxicity or disease progression.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Rong Tao, MD — Fudan University
• Study coordinator: Rong Tao, MD
• Email: rtao@shca.org.cn
• Phone: 8621-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.