Pharmacokinetics, Efficacy and Safety of the 304 Injection
NCT ID: NCT03980379
Last Updated: 2019-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
60 participants
INTERVENTIONAL
2018-12-18
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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experimental group
304 injection.WILL be administered single dose IV in the patients with CD20 positive B cell NHL
304 injection
Monoclonal antibodies, 100mg/10ml per injection
control group
Rituximab will be administered single dose IV in the patients with CD20 positive B cell NHL.
rituximab injection
100mg/10ml per injection ，manufactured by Roche
Interventions
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304 injection
Monoclonal antibodies, 100mg/10ml per injection
rituximab injection
100mg/10ml per injection ，manufactured by Roche
Eligibility Criteria
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Inclusion Criteria
* Previous treatments with CR/CRu (see Appendix 1 for lymphoma efficacy criteria) and those with CD20-positive B-cell non-Hodgkin's lymphoma who have not yet worsened and relapsed believe that they can benefit from anti-CD20 monoclonal antibody therapy. The diagnosis of CRu requires complete raw data (using CT findings. The preferred enhanced CT examination)
* At the time of enrollment, the Eastern Oncology Cooperative Group (ECOG) had a physical status score of ≤1 (see Appendix 2 for the evaluation criteria for the ECOG physical status score) and the expected survival period was more than four months
* In the screening test, WBC≥3×109/L, HGB≥80g/L, ANC≥1.5×109/L, PLT≥75×109/L, left ventricular ejection fraction (LVEF) ) ≥ 50%
* Female patients of childbearing age were negative for the blood pregnancy test during the screening period. Patients of childbearing age are willing to contraception after signing the informed consent form until 6 months after the end of the study treatment, including but not limited to: hormonal contraception, or physical contraception, or abstinence
* Be able to understand and comply with clinical trial protocol requirements and voluntarily sign written informed consent
Exclusion Criteria
* Those who have used chemotherapy drugs within 4 weeks before enrollment
* The clinical half-life of more than 5 drugs after taking other clinical trials in three months or other clinical trials (whichever is longer)
* The last time you used rituximab or other anti-CD20 mAbs for no more than 4 months
* In the screening test, the liver and kidney function tests have any of the following abnormalities: total bilirubin \> 1.5 times the upper limit of normal, ALT \> 2.5 times the upper limit of normal, AST \> 2.5 times the upper limit of normal, ALP \> 2.5 times the upper limit of normal, Blood Cr\>1.5 times the upper limit of normal value
* Hyperthyroidism
* He was transfused within 2 weeks before enrollment, or hematopoietic cytokine therapy, such as granulocyte colony-stimulating factor (G-CSF), thrombopoietin, erythropoietin, etc.
* Those who were vaccinated or planned to vaccinate (attenuate) live virus vaccine within 4 weeks prior to enrollment;
* Oversized surgery (not including diagnostic surgery) in the past 8 weeks;
* Have evidence or history of central nervous system involvement or cranial neuropathy;
* Treponema pallidum antibody positive, or HIV antibody positive, or HCV antibody positive;
* HBV examination showed one of the following results: a, HBsAg positive; b, although HBsAg negative, but anti-HBc positive and peripheral blood HBV DNA titer can be measured;
* Have had herpes zoster and have sequelae or latent infections;
* Patients with a history of severe heart disease, including but not limited to: New York Heart Association NYHA class II-IV heart failure (see Appendix 3 for NYHA heart failure grading), uncontrolled angina or arrhythmia, heart conduction above II Blocking, myocardial infarction occurred within 6 months
* Serious illnesses that have been or are currently suffering from any other organ or system (including but not limited to: severely active infections, uncontrolled diabetes, uncontrolled hypertension/hypotension, cerebrovascular disease, gastric ulcers, respiratory diseases, activities) Sexual autoimmune diseases, etc.; and any other medical history that the subject judges to be unsuitable for participating in the trial;
* Pregnant or lactating female subjects, or those who are unwilling to contraception during the trial
* Severe allergies, or any component known to be rituximab or other anti-CD20 mAbs or allergic to murine proteins;
* Subjects had a history of drug abuse or a history of smoking and drinking during the first 6 months of enrollment;
* The investigator judged that the patient was not suitable for entering any other circumstances of the trial
18 Years
75 Years
ALL
No
Sponsors
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The 307 Hospital of People's Liberation Army
Beijing, Beijing Municipality, China
Beijing Luhe Hospital Capital Medical University
Beijing, Beijing Municipality, China
Sun Yat-Sen University Cancer Hospital
Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Affiliated Hospital of Hebei University
Baoding, Heibei, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
The First Affiliated Hospita of Zhengzhou University
Zhengzhou, Henan, China
Weihai Municipal Hospital
Weihai, Shandong, China
Tianjin Medical University Cancer Institute &Hospital
Tianjing, Tianjing, China
The Second Affiliated Hospital of Soochow University
Suzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SSGJ-304-NHL-I-02
Identifier Type: -
Identifier Source: org_study_id
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