SHR-1210 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma
NCT03363555 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97
Last updated 2020-06-18
Summary
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.
Conditions
- Extranodal NK/T-cell Lymphoma, Nasal Type
Interventions
- DRUG
-
SHR-1210
A humanized monoclonal immunoglobulin.
Sponsors & Collaborators
-
Jiangsu HengRui Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-29
- Primary Completion
- 2019-06-30
- Completion
- 2021-06-30
Countries
- China
Study Locations
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