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

Sponsor

Sinocelltech Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02206308

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
B-cell Non Hodgkin's Lymphoma	Biological: Chimeric anti-CD20 monoclonal antibody	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single arm 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 Other Names: SCT400

Arm

Intervention/Treatment

Experimental: single arm

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

Other Names:

SCT400

Outcome Measures

Primary Outcome Measures

Number of participants with infusion-related reaction and with drug-related adverse events. [up to 27 weeks]

Secondary Outcome Measures

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]

Other Outcome Measures

Time to disease progression [up to 27 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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