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New treatment option for Relapsed/Refractory Peripheral T Cell Lymphoma
Official title Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma
ClinicalTrials.gov ID: NCT06519526
What this study is testing
What is SHR-0302?
SHR-0302 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for relapsed/refractory peripheral t cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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;
You likely can't join if
- Received anti-tumor treatment within 28 days prior to the first dose of the study drug; received Chinese medicine treatment with anti-tumor effect...
- 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;
See the full eligibility 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;
- 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...
- 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;
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.