WBC collection for CAR T-Cells for Immunotherapies research.
Research type
Research Study
Full title
White Blood Cell Collection for the Development of Chimeric Antigen Receptor (CAR) T-Cell Immunotherapies
IRAS ID
185945
Contact name
Kirsty Thomson
Contact email
Sponsor organisation
Autolus Ltd
Duration of Study in the UK
3 years, 0 months, 30 days
Research summary
Adoptive immunotherapy is showing promise and is increasingly being explored as a treatment for malignancy. Briefly, T-cells are isolated from a patient or a donor through venesection or leukapheresis. T-cells are manipulated in various ways in the cell processing lab to generate T-cells with the desired specificity and function. Manipulations include: selection for antigen specificity; genetic engineering to insert receptors and/or other component; or genetic editing to disrupt certain genes; expansion and cryopreservation. At present, many approaches for adoptive immunotherapy are being evaluated in phase 1, 2 and 3 clinical trials, and many more are in pre-clinical development.
Prior to initiating a clinical trial, T-cell engineering methods. A sufficient source of T-cells is hence needed to develop and validate these T-cell engineering methods.
This protocol has been established to provide a sufficient source of normal healthy donor T-cells for this application. White blood cells are harvested from normal healthy adult volunteers by leukapheresis at experienced apheresis collection units in the UK.
The harvested cells will be manipulated in the research laboratory to test the process of converting T-cells into therapeutic products prior to scaling up the production for the conduct of clinical trials. T-cell products will be analysed and tested and ultimately discarded in accordance with national and/or local guidelines. The only intervention to the project participant is the procedure to harvest the whole blood cells.
Leukapheresis is a process in which blood is removed from one arm; it passes through a specialized equipment which removes white blood cells and returns red blood cells and plasma back to the donor via their other arm.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
15/LO/1322
Date of REC Opinion
1 Sep 2015
REC opinion
Favourable Opinion