RecruitingPhase 2NCT06519526

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


Sponsor

Fudan University

Enrollment

25 participants

Start Date

Aug 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two experimental drugs (SHR-0302 and SHR-2554) in people with a type of blood cancer called peripheral T-cell lymphoma that has come back or stopped responding to previous treatment. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with peripheral T-cell lymphoma confirmed by biopsy - The cancer has relapsed or stopped responding to at least one prior treatment - You have measurable disease on imaging - You are in good general health (ECOG score 0 or 1) - You have a life expectancy of at least 12 weeks **You may NOT be eligible if...** - You received anti-cancer treatment in the past 28 days - You had major surgery in the past 4 weeks - You have serious heart, lung, or liver disease - You had a stroke or mini-stroke in the past 6 months - You have an active infection or unexplained fever - You are pregnant - You have a history of alcohol or drug abuse Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-0302

SHR-0302 will be administered orally as tablets.

DRUGSHR-2554

SHR-2554 will be administered orally as tablets.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT06519526


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