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Trial Title:
Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma
NCT ID:
NCT06519526
Condition:
Relapsed/Refractory Peripheral T Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-0302
Description:
SHR-0302 will be administered orally as tablets.
Arm group label:
SHR-0302 and SHR-2554 Treatment Arm
Intervention type:
Drug
Intervention name:
SHR-2554
Description:
SHR-2554 will be administered orally as tablets.
Arm group label:
SHR-0302 and SHR-2554 Treatment Arm
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.
Detailed description:
This is an open-label, prospective, exploratory clinical study. The plan is to enroll
12-25 patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL) to receive
a combination of SHR-0302 and SHR-2554. The primary objectives are to evaluate the
efficacy and safety of the SHR-0302 and SHR-2554 combination in the treatment of r/r
PTCL. Subjects will receive the investigating drugs combination (SHR-0302 and SHR-2554)
until study completion, unacceptable toxicity, disease progression, withdrawal of
informed consent, or investigators discontinue treatment.
The study is divided into two parts. Part I is a safety run-in phase, and part II is an
efficacy exploration phase.
Part I:
Cohort 1: Explore the recommended dose and safety of SHR-0302 monotherapy Cohort 2: Based
on the efficacy and safety observed in Cohort 1, explore the clinically recommended dose
and safety of the SHR-0302 and SHR-2554.
Part II: Based on the safety and tolerability observed during part I, the investigators
will discuss and select one tolerable dose cohort to explore the efficacy and safety.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Rong Tao, MD
Phone:
8621-64175590
Email:
rtao@shca.org.cn
Contact backup:
Last name:
Chuanxu Liu, MD
Phone:
8621-64175590
Email:
liuchuanxu@shca.org.cn
Investigator:
Last name:
Rong Tao, MD
Email:
Principal Investigator
Start date:
August 12, 2024
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06519526
