Controlling Hyperactive Immunity with Long-lasting Lymphocytes (CHILL)
Research type
Research Study
Full title
A single-arm, open-label, multi-centre, phase I/II first-in-human study evaluating the safety and clinical activity of QEL-005, an autologous CAR T-regulatory cell therapy treatment targeting CD19, in patients with diffuse cutaneous systemic sclerosis (dcSSc) and in patients with difficult to treat rheumatoid arthritis (D2TRA)
IRAS ID
1012972
Contact name
Gareth Wright
Contact email
Sponsor organisation
Quell Therapeutics Limited
Research summary
This study is being conducted to find out if different doses of a new investigational product called QEL-005 is safe, reduces disease symptoms and improves quality of life (well-being) after a single administration to adults with difficult to treat rheumatoid arthritis (D2TRA) and diffuse cutaneous systemic sclerosis (dcSSc).
D2TRA and dcSSc are long-lasting and hard-to-treat autoimmune diseases. Autoimmune diseases happen when a person’s immune system attacks normal cells in their body, and in D2TRA and dcSSc, this can be caused by overactive immune cells called ‘B cells’.
QEL-005 is made from a person’s own immune cells called T Regulatory Cells (also called Tregs), which will be collected and changed in a lab and put back into the person to try and regulate (control and calm) the immune system. These T regs are changed to be able to find B cells, and calm them down, which may dampen or stop the B cell activity that keeps D2TRA and dcSSc disease going. It is hoped these Tregs will have a long-lasting ability to calm B cells and therefore provide long-term control of these diseases.
Eligible participants will have their blood cells collected using a procedure called leukapheresis, which will be used to make QEL-005. Following the collection it will take about 6-8 weeks to make QEL-005. In order to assess the disease before the
administration of the investigational product (QEL-005), participants may have the following procedures performed, biopsies (small pieces of tissue removed from the body) of the joint (D2TRA) or skin (dcSSc) and lymph nodes (all participants) and images/scans.QEL-005 will be given once by intravenous infusion, with an overnight stay in hospital afterwards for monitoring. Regular safety checks will be performed approximately every 1 to 4 weeks to start with, then every 3 months, and then once a year from year 2 through to year 15.
This study is being conducted in hospitals in the UK, Germany and Spain.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
25/SC/0398
Date of REC Opinion
22 Jan 2026
REC opinion
Further Information Favourable Opinion