AuToDeCRA-2
Research type
Research Study
Full title
A single-centre, experimental medicine study investigating the route of delivery and potential efficacy of autologous tolerogenic dendritic cell (tolDC) therapy for Rheumatoid Arthritis
IRAS ID
1006392
Contact name
John Isaacs
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Eudract number
2023-000020-11
ISRCTN Number
ISRCTN14999554
Research summary
Rheumatoid Arthritis (RA) is a long-term autoimmune condition, caused by the immune system attacking health body tissue. We have previously trialled a new therapy for RA called tolerogenic dendritic cells (tolDC) which is manufactured from the patient's own white blood cells. The AuToDeCRA trial showed that tolDCs could be made from the white blood cell samples of patients with RA and that the treatment was safe to give to patients with active arthritis.
In that trial, tolDCs were injected directly into affected knee joints but we do not know if this is the best way to introduce the therapy. The AuToDeCRA-2 trial will compare a range of different administration routes and doses to see if how we administer the treatment impacts how well the treatment works at reducing the symptoms of RA. It will also look to identify any changes in the body’s immune system triggered by the treatment.
We aim to treat 20 patients in total, 16 with tolDC in addition to standard care and 4 with standard care alone. Three different routes of administration will be tested, directly into the lymph nodes, into the skin of the upper thigh and into a knee joint. Lymph nodes are small glands in the body where cells from the immune system congregate. Because we think that tolDC need to get to the lymph nodes to work, we are also testing whether a lower dose would be sufficient when injecting directly into a lymph node.
Participants will be randomised to one of the five groups, attending 7-8 visits over a period of up to 25 weeks. Those randomised to receive tolDC will undergo a procedure called leukapheresis to collect the white blood cells from which the treatment will be manufactured. During the trial blood and lymph node samples will be collected to identify changes in the immune system triggered by the treatment. Participants will also be assessed for signs of safety, efficacy and acceptability.REC name
London - West London & GTAC Research Ethics Committee
REC reference
23/LO/0494
Date of REC Opinion
25 Sep 2023
REC opinion
Further Information Favourable Opinion