A PRE-CLINICAL STUDY TO PROFILE & TEST HEALTHY DONOR NEUTROPHILS
Research type
Research Study
Full title
A PRE-CLINICAL STUDY TO PROFILE & TEST HEALTHY DONOR NEUTROPHILS CANCER KILLING
IRAS ID
308203
Contact name
Oxana Polyakova
Contact email
Sponsor organisation
LIfT BioSciences Ltd
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
LIfT Biosciences intends to bring to market a 1st in class cell therapy termed N-LIfT. N-LIfT uses a specific subtype of N1a neutrophil, with exceptional cancer killing and immune recruitment capabilities, only found in a small proportion of donors (<10%). The aim of this study is to build the world's first cell bank of haematopoietic stem cells (HSCs) from which we can develop our potentially curative 'cancer killing neutrophil' to treat a range of solid tumours with unmet medical needs. This study will support the running of our Proof-of-Concept clinical trial next year.
Donors identified from Anthony Nolan donor register who satisfy our criteria (age 18-35, no immediate family history of cancer) will be screened through a simple blood test. Neutrophils collected will be mixed with cancer cells and their cancer killing activity will be assessed through a functional assay over 24 hours. Once exceptional eligible donors are identified and have given their explicit consent, they will have their neutrophil production enhanced by a 4-day course of G-CSF-stimulation. Their stem cells will be collected from peripheral blood as a one-day outpatient procedure and stored in our cell bank for use in development of N-LIfT product.
We will source CD34+ from 20 different donors, selected based on their exceptional cancer killing activity, to potentially treat 60 cancer patients.
The study is expected to last approximately 18 months, separated into three phases: Phase 1 - identification of eligible donors; Phase 2 - donor screening to identify exceptional donors; Phase 3 - harvest of stem cells from specific donors.
Our partnership with Anthony Nolan and their 600,000 donors pool provides rapid access to a pool of appropriate donors and more scalable approach to conducting our own donor recruitment to get the best possible donors for developing a curative cancer therapy.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0445
Date of REC Opinion
12 May 2023
REC opinion
Further Information Favourable Opinion