NCT06519526 Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma
| NCT ID | NCT06519526 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Relapsed/Refractory Peripheral T Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-08-12 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2024-08-12 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Rong Tao, MD
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT06519526 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Relapsed/Refractory Peripheral T Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06519526 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06519526 currently recruiting?
Yes, NCT06519526 is actively recruiting participants. Contact the research team at rtao@shca.org.cn for enrollment information.
Where is the NCT06519526 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06519526 clinical trial?
NCT06519526 is sponsored by Fudan University. The principal investigator is Rong Tao, MD at Fudan University. The trial plans to enroll 25 participants.