Actively Recruiting
Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma
Led by Fudan University · Updated on 2026-03-24
25
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18-70 years (inclusive)
- Histologically confirmed peripheral T-cell lymphoma
- Disease status is relapsed or refractory after at least one prior systemic treatment
- Have measurable lesions
- ECOG performance status of 0 or 1 with no recent worsening in the last 2 weeks
- Life expectancy of at least 12 weeks
- Adequate bone marrow and organ function
- Able and willing to follow the study protocol requirements
You will not qualify if you...
- Received anti-tumor treatment within 28 days before first dose
- Received Chinese medicine with anti-tumor effect within 14 days before first dose
- Received steroid hormones within 7 days before first dose
- Underwent major surgery within 4 weeks before first dose
- Severe cardiovascular disease
- Cerebrovascular accident or transient ischemic attack within 6 months before enrollment
- Significant lung function impairment
- Active infections
- Unexplained fever over 38.5 during screening or on first medication day
- Pregnant
- Known alcohol or drug abuse
- Currently taking potent CYP inducers/inhibitors or P-glycoprotein inhibitors
- History of allergy to the study drugs or their ingredients
- Conditions or factors that could prevent completion of the study or risk forced termination as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
R
Rong Tao, MD
CONTACT
C
Chuanxu Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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