AGB002 - SAIT101 vs Rituximab in patients with low tumour burden FL
Research type
Research Study
Full title
A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients with Low Tumor Burden Follicular Lymphoma
IRAS ID
208631
Contact name
Simon Watt
Contact email
Sponsor organisation
Archigen Biotech Limited
Eudract number
2016-001966-27
Duration of Study in the UK
3 years, 0 months, 15 days
Research summary
The study drug being assessed in this study is an investigational medication called SAIT101, which is a type of drug known as a ‘biosimilar’. This means that it is biologically similar to a medication called rituximab that has already been approved by regulatory agencies in several countries for the treatment of non-Hodgkin’s lymphoma. Low tumour burden follicular lymphoma (LTBFL) is known as one type of non-Hodgkin’s lymphoma. The purpose of the study is to evaluate how well the study drug works and how safe it is, compared to rituximab. In addition, this study will compare the study drug and rituximab with regards to how they affect the body’s immune system by checking if the immune system produces antibodies (proteins that stick to things that the body thinks may cause harm or infection) to the study drugs. LTBFL is caused by abnormal B cells. SAIT101 works by attaching itself to B cells, a type of white blood cell that, when healthy, helps the body fight infection. The attachment of SAIT101 to B cells leads to a decrease in the number of these cells in the body. The study drug is thought to work with the body’s immune system to eliminate these abnormal B cells.
Subjects will be randomised on a 1:1 basis to either the study drug or rituximab.
The study will consist of a screening period (up to 30 days), a treatment period (4 weeks), and a follow-up period (48 weeks).
During the treatment period, subjects will receive an intravenous (IV) infusion of 375 mg/m2 of the study drug or rituximab calculated based on their height and weight.
A sub-population of approximately 48 patients (24 patients per group) will be used for PK (what the body does to the drug) and PD (what the drug does to the body) assessments for the analysis of rituximab PK and PD.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0436
Date of REC Opinion
23 Dec 2016
REC opinion
Further Information Favourable Opinion