Clinical trial NCT02206308: Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: B-cell Non Hodgkin's Lymphoma
Keywords: Chimeric anti-CD20 monoclonal antibody(SCT400)
escalating doses
safety
pharmacokinetics and pharmacodynamics
Lead sponsor: Sinocelltech Ltd.
Sponsor class: INDUSTRY
First posted: 2014-08-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with infusion-related reaction and with drug-related adverse events.
timeFrame: up to 27 weeks
Secondary outcomes:
measure: Area Under the plasma concentration versus time curve (AUC) of SCT400
timeFrame: prior to the initial dose on day 1 and 0,2,4,8,24,48,72,96,120 hours post-dose
Other outcomes:
measure: Time to disease progression
timeFrame: up to 27 weeks
Locations:
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing， China
name: Yuan kai Shi, PhD
role: PRINCIPAL_INVESTIGATOR
References: