SHR-1210 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma
Primary Purpose
Extranodal NK/T-cell Lymphoma, Nasal Type
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1210
Sponsored by
About this trial
This is an interventional treatment trial for Extranodal NK/T-cell Lymphoma, Nasal Type
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;
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5×ULN
- Serum Creatinine ≤1.25×ULN or Creatinine clearance≥45 mL/min;
- Coagulation function index:INR ≤1.5×ULN,APTT≤1.5×ULN
- 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
- 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.
- Known and suspicion of interstitial pneumonia
- Other active malignancies that required treating.
- Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except trichomadesis) did not recover to CTCAE ≤1.
- Prior allo-HSCT.
- ASCT within 90 days.
- Impact of major surgery or severe trauma had been eliminated for less than 14 days.
- Active pulmonary tuberculosis.
- Severe acute or chronic infection requiring systemic therapy.
- Suffering from heart failure (New York Heart Association standard III or IV) and given appropriate medical treatment.Uncontrolled coronary artery disease and arrhythmia. History of myocardial infarction within 6 months.
laboratory test
- known HIV positive or known AIDS.
- Untreated active hepatitis; Hepatitis B and hepatitis C infection in common.
- 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
Sites / Locations
- First Affiliated Hospital of Zhengzhou University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SHR-1210
Arm Description
SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes.
Outcomes
Primary Outcome Measures
objective response rate
rate of subjects achieved complete response plus partial response in all evaluable subjects
Secondary Outcome Measures
Full Information
NCT ID
NCT03363555
First Posted
November 29, 2017
Last Updated
June 17, 2020
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03363555
Brief Title
SHR-1210 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 29, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal NK/T-cell Lymphoma, Nasal Type
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-1210
Arm Type
Experimental
Arm Description
SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes.
Intervention Type
Drug
Intervention Name(s)
SHR-1210
Intervention Description
A humanized monoclonal immunoglobulin.
Primary Outcome Measure Information:
Title
objective response rate
Description
rate of subjects achieved complete response plus partial response in all evaluable subjects
Time Frame
from first patient first visit to 6 month after last patient first visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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;
Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5×ULN
Serum Creatinine ≤1.25×ULN or Creatinine clearance≥45 mL/min;
Coagulation function index:INR ≤1.5×ULN,APTT≤1.5×ULN
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
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.
Known and suspicion of interstitial pneumonia
Other active malignancies that required treating.
Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except trichomadesis) did not recover to CTCAE ≤1.
Prior allo-HSCT.
ASCT within 90 days.
Impact of major surgery or severe trauma had been eliminated for less than 14 days.
Active pulmonary tuberculosis.
Severe acute or chronic infection requiring systemic therapy.
Suffering from heart failure (New York Heart Association standard III or IV) and given appropriate medical treatment.Uncontrolled coronary artery disease and arrhythmia. History of myocardial infarction within 6 months.
laboratory test
known HIV positive or known AIDS.
Untreated active hepatitis; Hepatitis B and hepatitis C infection in common.
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
Facility Information:
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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SHR-1210 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma
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