Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, multi-center, nonrandomized, Phase 2 study to evaluate efficacy and safety of SHR-1210 in subjects with relapsed or refractory extranodal NK/T cell lymphoma.Efficacy will be assessed every 8 weeks according to 2014 Lugano criteria.Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.
The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 in patients with relapsed or refractory extranodal NK/T cell lymphoma. The secondary objective is to observe time to response,progression free survival rate at 2 years,overall survival rate at 2 years,safety and immunogenicity of SHR-1210 in relapsed or refractory extranodal NK/T cell lymphoma.The relationship of PD-L1 expression in tumor tissue and EBV-DNA copies in blood to SHR-1210 efficacy in these patients would also be explored.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210 | Experimental | SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | A humanized monoclonal immunoglobulin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | rate of subjects achieved complete response plus partial response in all evaluable subjects | from first patient first visit to 6 month after last patient first visit |
Not provided
Not provided
Inclusion Criteria:
Histologically confirmed extranodal NK/T cell lymphoma;
Relapsed or refrsctory cHL and received L-asparaginase based chemotherapy.
Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
Need to provide ≥5 tumor tissue sections for detection.
ECOG performance status of 0 or 1;
Life expectancy ≥ 12 weeks.;
Adequate laboratory parameters during the screening period as evidenced by the following:
Women of childbearing potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 60 days after receiving the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7days before entering the group and not in in lactation; Male subjects with WOCBP partner should receive Surgical sterilization orconsent to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment.
Able to understand and sign an informed consent form (ICF).
Exclusion Criteria:
invasive NK cell leukemia or precursor NK cell tumor
Known central nervous system lymphoma
Haemophilus cell syndrome at diagnosis
Large lung vessels were involved
History and complication
laboratory test
Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D009369 |
| Neoplasms |