An Open-Label, Single Arm, Multi-Center, Phase 2 Study of PD-1 Antibody SHR-1210 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- SHR-1210
- Conditions
- Extranodal NK/T-cell Lymphoma, Nasal Type
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 97
- Locations
- 1
- Primary Endpoint
- objective response rate
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility Criteria
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:
- •Absolute neutrophil count ≥ 1.0× 109/L ;
- •Platelets ≥ 75 × 109/L;
- •Hemoglobin ≥ 8.0 g/dL;
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
- •Recieved anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months.
- •Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody .
- •Participating in other clinical studies or less than 4 weeks before the end of a clinical trial;
- •Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted.
- •Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids \> 10mg.
Arms & Interventions
SHR-1210
SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes.
Intervention: SHR-1210
Outcomes
Primary Outcomes
objective response rate
Time Frame: from first patient first visit to 6 month after last patient first visit
rate of subjects achieved complete response plus partial response in all evaluable subjects