New pill combo targets tough lymphoma

NCT ID NCT06519526

Disease control Sponsor: Fudan University Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 2 trial tests two oral drugs, SHR-0302 and SHR-2554, in about 25 people with peripheral T-cell lymphoma that has come back or not responded to prior treatment. The drugs work by blocking specific proteins that help cancer grow. The study aims to see if the combination is safe and can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: SHR-0302 (a JAK inhibitor) and SHR-2554 (an EZH2 inhibitor), both taken as pills
What this could lead to: If successful, this combination could offer a new treatment option for patients with hard-to-treat peripheral T-cell lymphoma.
What could go wrong: This is a small, early-phase trial with only 25 participants, so results may not apply broadly. The drugs may cause side effects or fail to shrink tumors.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

mature T-cell and NK-cell non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed/refractory peripheral T-cell lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New pill combo targets tough lymphoma

What the study statuses mean