Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.

Study Overview
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Brief Summary
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The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma

Official Title
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A Phase I Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SCT400, a Recombinant Chimeric Anti-CD20 Monoclonal Antibody，in Patients With CD20+ B-cell Non Hodgkin's Lymphoma.

Conditions
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B-cell Non Hodgkin's Lymphoma

Intervention / Treatment
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* Biological: Chimeric anti-CD20 monoclonal antibody


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged from 18 to 75 years having histologically confirmed NHL expressing CD20 antigen having relapsed non-Hodgkin's lymphoma(NHL) after at least one prior course of standard therapy Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 according to WHO scale, and expected survival of at least ≥ 3 months signed an informed consent form which was approved by the institutional review board of the respective medical center Exclusion Criteria: single measurable lesion ≥7 cm in diameter with serious hematologic dysfunction (white blood cell count of <3.0×103/μL; absolute neutrophil count of <1.5×103/ μL; platelet count of < 75×103/μL; hemoglobin level of < 8.0 g/dL; serum immunoglobulin G(IgG) level of <600 mg/dL);, hepatic dysfunction (total bilirubin level of > 1.5×upper limit of normal（ULN）; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of >2.5 × ULN (≥5 × ULN for patients with liver metastases)); and renal dysfunction (serum creatinine level of > 1.5×ULN ) having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or participating in other clinical trial or have not recovered from significant toxicities of prior therapy had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment had received hematopoietic cytokines, e.g CSF、EPO within 1 week prior to study entry with other malignancies ; or central nervous system (CNS) lymphoma, AIDS- related lymphoma; or active opportunistic infection, a serious nonmalignant disease having hepatitis B virus surface antigen and /or antibodies to hepatitis C virus or human immunodeficiency virus with pleural effusions or ascites secondary to lymphoma; or high risk of tumor lysis syndrome; or recent major surgery (within 28 days ) with a history of allergic reaction or protein product allergy including murine proteins pregnant or lactating or not accepted birth control methods including male patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br>Three escalating single-dose groups of chimeric anti-CD20 monoclonal antibody(SCT400) : 250 mg/m2 , 375 mg/m2，500 mg/m2, once a week for 4 doses; | Biological: Chimeric anti-CD20 monoclonal antibody<br> <br> * Other names: SCT400;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with infusion-related reaction and with drug-related adverse events. |  | up to 27 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the plasma concentration versus time curve (AUC) of SCT400 |  | prior to the initial dose on day 1 and 0,2,4,8,24,48,72,96,120 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chimeric anti-CD20 monoclonal antibody(SCT400), escalating doses, safety, pharmacokinetics and pharmacodynamics