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

Sinocelltech

Status and phase

Completed

Phase 1

Conditions

B-cell Non Hodgkin's Lymphoma

Treatments

Biological: Chimeric anti-CD20 monoclonal antibody

Study type

Interventional

Funder types

Industry

Identifiers

NCT02206308

SCT400NHLI

Details and patient eligibility

About

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

Enrollment

15 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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