Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.
Phase 1
Completed
- Conditions
- B-cell Non Hodgkin's Lymphoma
- Interventions
- Biological: Chimeric anti-CD20 monoclonal antibody
- Registration Number
- NCT02206308
- Lead Sponsor
- Sinocelltech Ltd.
- Brief Summary
The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single arm Chimeric anti-CD20 monoclonal antibody 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;
- Primary Outcome Measures
Name Time Method Number of participants with infusion-related reaction and with drug-related adverse events. up to 27 weeks
- Secondary Outcome Measures
Name Time Method 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