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

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

This study is testing a new combination of two drugs to see if they can help people with relapsed peripheral T-cell lymphoma feel better and improve their treatment options.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fudan University (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06519526 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with histologically confirmed relapsed or refractory peripheral T-cell lymphoma who have measurable lesions.

Not a fit: Patients who have received anti-tumor treatment within a specified timeframe or have severe cardiovascular disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with relapsed or refractory peripheral T-cell lymphoma.

How similar studies have performed: While this approach is exploratory, similar studies involving JAK and EZH2 inhibitors have shown promise in other hematological malignancies.

Eligibility criteria

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 this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Rong Tao, MD — Fudan University
• Study coordinator: Rong Tao, MD

Conditions: Relapsed/Refractory Peripheral T Cell Lymphoma